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CompletedNCT01240915Updated Feb 23, 2016Results posted

A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis

A Phase 2 interventional study of placebo and MultiStem low dose in Colitis, Ulcerative, sponsored by Pfizer. Completed at 58 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-23.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

MultiStem(r) is a new biological product, manufactured from human stem cells obtained from adult bone marrow or other nonembryonic tissue sources. Factors expressed by MultiStem cells are believed to reduce inflammation and regulate immune system function, protect damaged or injured cells and tissue, promote formation of new blood vessels, and augment tissue repair and healing. MultiStem cell treatment resulted in significant efficacy in a mouse model of Graft versus Host Disease with almost complete reversal of gastrointestinal pathology (similar to pathology that would be expected in Ulcerative Colitis). These data, together with safety data generated in 2 other clinical trials, suggest that MultiStem has the potential to be a new treatment option for patients with ulcerative colitis. This is the first study of MultiStem in this patient population and will cautiously explore the safety/toleration and potential benefit of this new treatment in patients with moderate to severe disease.

02

Conditions studied

  • Colitis, Ulcerative

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Keywords

  • safety efficacy MultiStem(r) moderate to severe Ulcerative Colitis
03

In context

Colitis, Ulcerative

1,530 studies on the registry are indexed under Colitis, Ulcerative; 407 are open to participants now.

This study's enrollment of 105 is above the median of 70 across 1,069 interventional studies indexed under Colitis, Ulcerative.

Browse Colitis, Ulcerative studies →

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Browse Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects must have a documented diagnosis of ulcerative colitis at least 6 months prior to screening.
  • Subjects must have active moderate-to-severe ulcerative colitis based on Mayo score.
  • Subjects must have Modified Baron endoscopic score of at least 2 determined within 7 days of first dosing.
  • Subjects must have failed or be intolerant (as determined by the investigator) of at least one of the following treatments for UC: Oral corticosteroids, azathioprine or 6-mercaptopurine (6-MP), or anti-tumor necrosis factor (TNF) therapy, eg, infliximab or adalimumab.
  • Subjects must be on stable steroid doses.

Exclusion criteria

Exclusion Criteria:

  • Subjects who have abnormal organ and marrow function.
  • Subjects with a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.
  • Subjects who meet Truelove-Witts criteria for severe ulcerative colitis.
  • Subjects receiving or who are expected to receive Infliximab or other biologic treatment within 8 weeks of the Day 1 study visit.
  • Subjects receiving or who are expected to receive Cyclosporine, mycophenolate, or tacrolimus within 4 weeks of the Day 1 study visit.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
105 participants (actual)

Study arms

  • Experimental
    Cohort 1

    The first 9 subjects will be recruited into Cohort 1 and will receive either placebo (n=3) or MultiStem low dose (n=6) as an intravenous infusion on Day 1. The first five patients enrolled constitute a subgroup of Cohort 1 and these patients will receive multiple doses, once every day for 7 days for 3 doses (Day 1 and Weeks 1 \& 2).

    Drug: placebo · Drug: MultiStem low dose

  • Experimental
    Cohort 2

    This group will receive either placebo (n=3) or MultiStem high dose (n=6) as an intravenous infusion on Day 1. The subjects then receive the opposite dose of study medication at Week 8.

    Drug: placebo · Drug: MultiStem high dose

  • Experimental
    Cohort 3

    These subjects (total n=88 evaluable patients) will receive either Placebo or MultiStem (1:1 randomization) as an intravenous infusion on Day 1. In addition all subjects in Cohort 3 will receive a single infusion of either MultiStem or Placebo at Week 8, depending on their randomization schedule. A total of \~22 patients will receive an additional infusion of MultiStem, \~44 patients will receive the alternative blinded therapy to that which they received for Day 1 infusion, and \~22 patients will receive an additional infusion of placebo.

    Drug: placebo · Drug: MultiStem high dose

Interventions

  • Drugplacebo

    once every 7 days for 1- 3 doses

  • DrugMultiStem low dose

    1-3 doses

  • Drugplacebo

    Single dose at week 8

  • DrugMultiStem low dose

    Single dose at week 8

  • Drugplacebo

    Single dose Day 1

  • DrugMultiStem high dose

    Single dose Day 1

  • Drugplacebo

    Single dose at week 8

  • DrugMultiStem high dose

    Single dose at week 8

  • Drugplacebo

    Single dose Day 1

  • DrugMultiStem high dose

    Single dose Day 1

  • Drugplacebo

    Single dose at week 8

  • DrugMultiStem high dose

    Single dose at week 8

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Endoscopic Score (as Measured by Modified Baron Score) at Week 8

    Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding).

    Time frame: Baseline and Week 8

  2. Change From Baseline in Rectal Bleeding Mayo Subscore at Week 4

    Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.

    Time frame: Baseline and Week 4

  3. Change From Baseline in Rectal Bleeding Mayo Subscore at Week 8

    Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.

    Time frame: Baseline and Week 8

  4. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.

    Time frame: Baseline up to Week 52

  5. Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC)

    Time frame: Baseline up to Week 52

  6. Number of Treatment-Emergent AEs by Severity

    The intensity grades were defined as follows: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function; severe=interferes significantly with participant's usual function.

    Time frame: Baseline up to Week 52

Secondary outcomes

  1. Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16

    Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.

    Time frame: Baseline, Week 12, Week 16

  2. Number of Participants With Laboratory Test Abnormalities

    The total number of participants with laboratory test abnormalities with or without regard to baseline abnormality was assessed. Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, platelet count, white blood cell \[WBC\] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, erythrocyte sedimentation rate); chemistry (blood urea nitrogen and creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy (only if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase); other (follicle-stimulating hormone, human chorionic gonadotropin, stool microbiology, creatinine kinase, direct bilirubin, indirect bilirubin, gamma-glutamyl transferase, international normalized ratio.

    Time frame: Baseline up to Week 24

  3. Number of Participants With Potentially Clinically Significant Vital Signs Findings

    Vital signs assessment included pulse rate, systolic blood pressure (SBP) and diastolic blood pressure (DBP). Criteria for vital sign values meeting potential clinical concern included: SBP \<90 millimeters of mercury (mm Hg) and \>=30 mm Hg increase/decrease from baseline, DBP \<50 mm Hg and \>=20 mm Hg increase/decrease from baseline, pulse rate \<40 or \>120 beats per minute (bpm),

    Time frame: Baseline up to Week 52

  4. Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16

    Fecal calprotectin, a very stable marker, is a 36kDa calcium and zinc binding protein which is neutrophil-derived. It represents 60% of cytosolic proteins in granulocytes and is a measurement of neutrophil migration to the gastrointestinal tract.

    Time frame: Baseline, Weeks 4, 8, 12 and 16

  5. Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16

    CRP is an acute-phase protein which provides an objective criterion of inflammatory activity. CRP has a short half-life (19 hours) and therefore rises early after the onset of inflammation and rapidly decreases after resolution of the inflammation. It is induced by interleukin-6, TNF-alpha and other pro-inflammatory cytokines that are produced within the intestinal lamina propria.

    Time frame: Baseline, Weeks 4, 8, 12 and 16

  6. Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16

    Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes).

    Time frame: Week 4, 8, 12 and 16

  7. Percentage of Participants in Endoscopic Remission at Week 8

    Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding). Endoscopic remission is defined as modified Baron Endoscopic Score equal to 0.

    Time frame: Week 8

  8. Percentage of Participants in Clinical Remission at Week 8

    Clinical remission is defined as a total Mayo score of 2 points or lower, with no individual subscores exceeding 1 point.

    Time frame: Week 8

  9. Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16

    Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes). A decrease from baseline score indicates improvement.

    Time frame: Baseline, Weeks 4, 8, 12 and 16

  10. Percentage of Participants With Endoscopic Response at Week 8

    Endoscopic response is defined as a decrease in modified Baron endoscopic score from baseline of at least 2 points.

    Time frame: Week 8

  11. Percentage of Participants in Clinical Response at Week 8

    Clinical response is defined as a decrease in total Mayo score from baseline of at least 3 points and at least 30 percent (%), with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1.

    Time frame: Week 8

  12. Change From Baseline in Total Mayo Scores at Week 8

    Mayo Score is an instrument designed to measure disease activity of ulcerative colitis, with total score ranging from 0 to 12. It consists of 4 subscores (stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy, and physician global assessment \[PGA\]), each graded from 0 to 3, with higher scores indicating more severe disease.

    Time frame: Baseline, Week 8

  13. Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16

    Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo Score ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease. A Partial Mayo Score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). Higher scores indicate more severe disease.

    Time frame: Baseline, Weeks 4, 8, 12 and 16

  14. Change From Baseline in Biopsy Histology Scores at Week 8

    A 15 to 25 centimeter (cm) biopsy sample of inflamed mucosal tissue was taken from the worst affected area and scored using the Riley Index. The Riley Index is a histologic scoring system for the assessment of the activity and severity of ulcerative colitis, ranging from 0 to 24. It consists of 6 histologic features (acute inflammatory cell infiltrate, crypt abscesses, mucin depletion, surface epithelial integrity, chronic inflammatory cell infiltrate, and crypt architectural irregularities), all scored on a 4-point scale (higher scores indicate more severe disease).

    Time frame: Baseline and Week 8

  15. Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16

    Patient-reported diary data assessed the number of bowel movements (BM) per day when not having a flare and the presence of blood in the stools (rectal bleeding \[RB\]), if any.

    Time frame: Baseline and Week 16

07

Results

Posted Feb 23, 2016

Participant flow

Participant flow — Overall Study
MilestoneCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
Started2324623251921
Completed0221213171513
Not completed2103410848
Withdrew: Adverse event000102001
Withdrew: Lost to follow-up000011011
Withdrew: Withdrawal by subject210204233
Withdrew: Other000020000
Withdrew: Insufficient clinical response000013603

Outcome measures

PrimaryChange From Baseline in Endoscopic Score (as Measured by Modified Baron Score) at Week 8

Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding).

Time frame:
Baseline and Week 8
Reported as:
Mean · scores on a scale
Change From Baseline in Endoscopic Score (as Measured by Modified Baron Score) at Week 8
scores on a scalePooled MultiStemPooled Placebo
Baseline3.13 ± 1.1043.10 ± 1.128
Change at Week 80.10 ± 1.134-0.30 ± 1.091
Statistical analysis
  • Pooled MultiStem vs Pooled Placebo · ANCOVA · p = 0.96 (1-sided p-value) · Mean difference (final values): 0.40 · 80% CI 0.12 to 0.69
PrimaryChange From Baseline in Rectal Bleeding Mayo Subscore at Week 4

Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.

Time frame:
Baseline and Week 4
Reported as:
Mean · scores on a scale
Change From Baseline in Rectal Bleeding Mayo Subscore at Week 4
scores on a scalePooled MultiStemPooled Placebo
Baseline1.42 ± 0.9421.23 ± 0.832
Change at Week 4-0.44 ± 0.943-0.38 ± 0.705
Statistical analysis
  • Pooled MultiStem vs Pooled Placebo · Mixed Models Analysis · p = 0.54 (1-sided p-value) · Mean difference (final values): 0.02 · 80% CI -0.19 to 0.22MMRM using data up to Week 8
PrimaryChange From Baseline in Rectal Bleeding Mayo Subscore at Week 8

Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.

Time frame:
Baseline and Week 8
Reported as:
Mean · scores on a scale
Change From Baseline in Rectal Bleeding Mayo Subscore at Week 8
scores on a scalePooled MultiStemPooled Placebo
Change From Baseline in Rectal Bleeding Mayo Subscore at Week 8-0.46 ± 1.051-0.43 ± 0.874
Statistical analysis
  • Pooled MultiStem vs Pooled Placebo · Mixed Models Analysis · p = 0.67 (1-sided p-value) · Mean difference (final values): 0.08 · 80% CI -0.15 to 0.30MMRM using data up to Week 8
PrimaryNumber of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.

Time frame:
Baseline up to Week 52
Reported as:
Number · participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
participantsCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
AEs2304520181619
SAEs100307454
PrimaryNumber of Participants With Treatment-Emergent AEs by System Organ Class (SOC)
Time frame:
Baseline up to Week 52
Reported as:
Number · participants
Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC)
participantsCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
BLOOD AND LYMPHATIC SYSTEM DISORDERS000005034
CARDIAC DISORDERS000001011
EAR AND LABYRINTH DISORDERS000001011
ENDOCRINE DISORDERS000000110
EYE DISORDERS000001003
GASTROINTESTINAL DISORDERS2102413101112
GENERAL DISORDERS210318556
IMMUNE SYSTEM DISORDERS000100200
INFECTIONS AND INFESTATIONS1101110997
INJURY, POISONING AND PROCEDURAL COMPLICATIONS010102221
INVESTIGATIONS010014153
METABOLISM AND NUTRITION DISORDERS000102011
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS020026521
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED000001000
NERVOUS SYSTEM DISORDERS010111396
PSYCHIATRIC DISORDERS000001132
RENAL AND URINARY DISORDERS000001100
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS110005514
SKIN AND SUBCUTANEOUS TISSUE DISORDERS000114432
SURGICAL AND MEDICAL PROCEDURES000001010
VASCULAR DISORDERS000021121
PrimaryNumber of Treatment-Emergent AEs by Severity

The intensity grades were defined as follows: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function; severe=interferes significantly with participant's usual function.

Time frame:
Baseline up to Week 52
Reported as:
Number · adverse events
Number of Treatment-Emergent AEs by Severity
adverse eventsCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
Mild AEs616081361355648
Moderate AEs4005233312117
Severe AEs1004013843
SecondaryChange From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16

Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.

Time frame:
Baseline, Week 12, Week 16
Reported as:
Mean · scores on a scale
Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16
scores on a scaleCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
Change at Week 12 (n=0,0,0,0,0,22,25,17,19)NA ± NANA ± NANA ± NANA ± NANA ± NA-0.77 ± 0.869-0.64 ± 1.114-0.53 ± 0.874-0.47 ± 0.905
Change at Week 16 (n=2,3,2,4,6,21,24,17,19)-1.50 ± 0.707-1.00 ± 1.0000.00 ± 0.0000.00 ± 0.816-0.60 ± 1.140-0.57 ± 0.978-0.92 ± 1.100-0.47 ± 0.874-0.58 ± 0.838
SecondaryNumber of Participants With Laboratory Test Abnormalities

The total number of participants with laboratory test abnormalities with or without regard to baseline abnormality was assessed. Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, platelet count, white blood cell \[WBC\] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, erythrocyte sedimentation rate); chemistry (blood urea nitrogen and creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy (only if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase); other (follicle-stimulating hormone, human chorionic gonadotropin, stool microbiology, creatinine kinase, direct bilirubin, indirect bilirubin, gamma-glutamyl transferase, international normalized ratio.

Time frame:
Baseline up to Week 24
Reported as:
Number · participants
Number of Participants With Laboratory Test Abnormalities
participantsCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
Normal/Abnormal Baseline(n=2,3,2,4,6,23,25,19,21)2214414201517
Normal Baseline (n=2,3,2,4,6,23,25,19,21)221349161213
Abnormal Baseline (n=2,3,2,2,3,22,19,15,18)111127446
SecondaryNumber of Participants With Potentially Clinically Significant Vital Signs Findings

Vital signs assessment included pulse rate, systolic blood pressure (SBP) and diastolic blood pressure (DBP). Criteria for vital sign values meeting potential clinical concern included: SBP \<90 millimeters of mercury (mm Hg) and \>=30 mm Hg increase/decrease from baseline, DBP \<50 mm Hg and \>=20 mm Hg increase/decrease from baseline, pulse rate \<40 or \>120 beats per minute (bpm),

Time frame:
Baseline up to Week 52
Reported as:
Number · participants
Number of Participants With Potentially Clinically Significant Vital Signs Findings
participantsCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
Supine SBP <90 mm Hg000020000
Supine DBP <50 mm Hg000000100
Supine Pulse Rate <40 bpm000000000
Supine Pulse Rate >120 bpm000003010
Supine SBP >=30 mm Hg Increase From Baseline000111312
Supine DBP >=20 mm Hg Increase From Baseline200103024
Supine SBP >=30 mm Hg Decrease From Baseline000101111
Supine DBP >=20 mm Hg Decrease From Baseline110006130
SecondaryFold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16

Fecal calprotectin, a very stable marker, is a 36kDa calcium and zinc binding protein which is neutrophil-derived. It represents 60% of cytosolic proteins in granulocytes and is a measurement of neutrophil migration to the gastrointestinal tract.

Time frame:
Baseline, Weeks 4, 8, 12 and 16
Reported as:
Geometric mean · fold change
Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16
fold changeCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
Baseline (n=2,3,1,4,5,21,23,19,20)690.7549 ± 171189.8169 ± 22739.2300 ± NA898.2758 ± 89874.1363 ± 1462576.5796 ± 237476.1504 ± 222513.2139 ± 208821.1953 ± 220
Change at Week 4 (n=2,3,1,3,5,20,21,18,19)0.6297 ± 501.8680 ± 1032.0264 ± NA2.0549 ± 1121.0940 ± 911.2196 ± 1580.8179 ± 3141.0541 ± 1660.6722 ± 193
Change at Week 8 (n=1,2,1,3,2,18,20,17,20)2.4504 ± NA2.4559 ± 512.6199 ± NA0.5744 ± 520.3282 ± 21.0704 ± 2200.7462 ± 2350.8598 ± 2270.3479 ± 242
Change at Week 12 (n=0,0,0,0,0,20,21,17,18)NA ± NANA ± NANA ± NANA ± NANA ± NA0.9947 ± 1710.8269 ± 3100.8788 ± 2930.5279 ± 171
Change at Week 16 (n=2,3,1,4,4,18,18,16,17)2.1672 ± 490.7679 ± 321.1956 ± NA0.4459 ± 1390.2474 ± 45170.6473 ± 2770.8486 ± 1490.5473 ± 3090.5275 ± 243
Statistical analysis
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.53 (1-sided p-value) · Geometric mean ratio: 1.02 · 80% CI 0.73 to 1.42MMRM using data up to Week 16
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.91 (1-sided p-value) · Geometric mean ratio: 1.48 · 80% CI 1.02 to 2.14MMRM using data up to Week 16
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.81 (1-sided p-value) · Geometric mean ratio: 1.38 · 80% CI 0.86 to 2.23MMRM using data up to Week 16
  • Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.44 (1-sided p-value) · Geometric mean ratio: 0.94 · 80% CI 0.59 to 1.51MMRM using data up to Week 16
  • Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.67 (1-sided p-value) · Geometric mean ratio: 1.18 · 80% CI 0.72 to 1.94MMRM using data up to Week 16
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.62 (1-sided p-value) · Geometric mean ratio: 1.12 · 80% CI 0.68 to 1.84MMRM using data up to Week 16
  • Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.95 (1-sided p-value) · Geometric mean ratio: 0.95 · 80% CI 0.58 to 1.57MMRM using data up to Week 16
  • Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.30 (1-sided p-value) · Geometric mean ratio: 0.81 · 80% CI 0.49 to 1.36MMRM using data up to Week 16
SecondaryFold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16

CRP is an acute-phase protein which provides an objective criterion of inflammatory activity. CRP has a short half-life (19 hours) and therefore rises early after the onset of inflammation and rapidly decreases after resolution of the inflammation. It is induced by interleukin-6, TNF-alpha and other pro-inflammatory cytokines that are produced within the intestinal lamina propria.

Time frame:
Baseline, Weeks 4, 8, 12 and 16
Reported as:
Geometric mean · fold change
Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16
fold changeCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
Baseline (n=2,3,2,4,6,22,25,19,20)1.272 ± 451.527 ± 1180.229 ± 340.578 ± 370.180 ± 740.613 ± 3390.542 ± 2360.397 ± 1570.453 ± 297
Change at Week 4 (n=2,3,2,3,6,21,25,18,20)0.289 ± 90.555 ± 821.937 ± 421.285 ± 601.446 ± 540.891 ± 1470.764 ± 1400.999 ± 1030.588 ± 132
Change at Week 8 (n=1,3,1,3,5,21,25,19,20)1.390 ± NA0.745 ± 492.331 ± NA1.172 ± 201.555 ± 311.189 ± 1460.759 ± 2071.200 ± 1130.623 ± 150
Change at Week 12 (n=0,0,0,0,0,21,24,17,18)NA ± NANA ± NANA ± NANA ± NANA ± NA0.937 ± 2110.710 ± 3650.782 ± 1490.373 ± 155
Change at Week 16 (n=2,3,2,4,5,20,24,17,18)0.956 ± 1640.481 ± 560.606 ± 2480.869 ± 141.184 ± 540.776 ± 1560.425 ± 1760.612 ± 1330.417 ± 197
Statistical analysis
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.79 (1-sided p-value) · Geometric mean ratio: 1.17 · 80% CI 0.91 to 1.51MMRM using data up to Week 16
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.80 (1-sided p-value) · Geometric mean ratio: 1.21 · 80% CI 0.90 to 1.63MMRM using data up to Week 16
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.99 (1-sided p-value) · Geometric mean ratio: 2.75 · 80% CI 1.63 to 4.64MMRM using data up to Week 16
  • Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.96 (1-sided p-value) · Geometric mean ratio: 1.96 · 80% CI 1.19 to 3.25MMRM using data up to Week 16
  • Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.95 (1-sided p-value) · Geometric mean ratio: 1.98 · 80% CI 1.15 to 3.41MMRM using data up to Week 16
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.99 (1-sided p-value) · Geometric mean ratio: 2.30 · 80% CI 1.52 to 3.48MMRM using data up to Week 16
  • Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.62 (1-sided p-value) · Geometric mean ratio: 1.10 · 80% CI 0.74 to 1.63MMRM using data up to Week 16
  • Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.89 (1-sided p-value) · Geometric mean ratio: 1.51 · 80% CI 0.98 to 2.32MMRM using data up to Week 16
SecondaryPercentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16

Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes).

Time frame:
Week 4, 8, 12 and 16
Reported as:
Number · percentage of participants
Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16
percentage of participantsCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
Week 450.066.750.033.340.052.228.031.642.9
Week 850.066.750.033.340.047.836.031.647.6
Week 12NANANANANA60.940.047.442.9
Week 1650.010050.050.040.047.848.036.852.4
Statistical analysis
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Regression, Logistic · p = 0.34 (1-sided p-value) · Odds ratio (or): 1.21 · 80% CI 0.66 to 2.19
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Regression, Logistic · p = 0.33 (1-sided p-value) · Odds ratio (or): 1.23 · 80% CI 0.68 to 2.23
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: Placebo, Placebo · Regression, Logistic · p = 0.10 (1-sided p-value) · Odds ratio (or): 2.37 · 80% CI 0.99 to 5.67
  • Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, Placebo · Regression, Logistic · p = 0.74 (1-sided p-value) · Odds ratio (or): 0.66 · 80% CI 0.28 to 1.55
  • Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Regression, Logistic · p = 0.48 (1-sided p-value) · Odds ratio (or): 1.04 · 80% CI 0.41 to 2.64
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: Placebo, Placebo · Regression, Logistic · p = 0.58 (1-sided p-value) · Odds ratio (or): 0.88 · 80% CI 0.38 to 2.03
  • Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, Placebo · Regression, Logistic · p = 0.68 (1-sided p-value) · Odds ratio (or): 0.74 · 80% CI 0.33 to 1.66
  • Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Regression, Logistic · p = 0.84 (1-sided p-value) · Odds ratio (or): 0.51 · 80% CI 0.21 to 1.23
SecondaryPercentage of Participants in Endoscopic Remission at Week 8

Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding). Endoscopic remission is defined as modified Baron Endoscopic Score equal to 0.

Time frame:
Week 8
Reported as:
Number · percentage of participants
Percentage of Participants in Endoscopic Remission at Week 8
percentage of participantsCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
Percentage of Participants in Endoscopic Remission at Week 8000016.74.34.009.5
Statistical analysis
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Regression, Logistic · p = 0.57 (1-sided p-value) · Odds ratio (or): 0.83 · 80% CI 0.22 to 3.07
SecondaryPercentage of Participants in Clinical Remission at Week 8

Clinical remission is defined as a total Mayo score of 2 points or lower, with no individual subscores exceeding 1 point.

Time frame:
Week 8
Reported as:
Number · percentage of participants
Percentage of Participants in Clinical Remission at Week 8
percentage of participantsCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
Percentage of Participants in Clinical Remission at Week 80000008.0019.0
Statistical analysis
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Regression, Logistic · p = 0.85 (1-sided p-value) · Odds ratio (or): 0.39 · 80% CI 0.12 to 1.23
SecondaryPercentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16

Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes). A decrease from baseline score indicates improvement.

Time frame:
Baseline, Weeks 4, 8, 12 and 16
Reported as:
Number · percentage of participants
Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16
percentage of participantsCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
Week 410066.70040.043.548.021.138.1
Week 810033.30040.034.848.031.647.6
Week 12NANANANANA54.560.041.252.6
Week 1610066.7025.060.047.658.335.347.4
Statistical analysis
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Regression, Logistic · p = 0.05 (1-sided p-value) · Odds ratio (or): 2.27 · 80% CI 1.21 to 4.24
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Regression, Logistic · p = 0.43 (1-sided p-value) · Odds ratio (or): 1.09 · 80% CI 0.61 to 1.95
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: Placebo, Placebo · Regression, Logistic · p = 0.44 (1-sided p-value) · Odds ratio (or): 1.11 · 80% CI 0.45 to 2.76
  • Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, Placebo · Regression, Logistic · p = 0.38 (1-sided p-value) · Odds ratio (or): 1.23 · 80% CI 0.50 to 3.04
  • Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Regression, Logistic · p = 0.89 (1-sided p-value) · Odds ratio (or): 0.38 · 80% CI 0.14 to 1.04
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: Placebo, Placebo · Regression, Logistic · p = 0.47 (1-sided p-value) · Odds ratio (or): 1.05 · 80% CI 0.45 to 2.42
  • Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, Placebo · Regression, Logistic · p = 0.24 (1-sided p-value) · Odds ratio (or): 1.58 · 80% CI 0.70 to 3.57
  • Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Regression, Logistic · p = 0.81 (1-sided p-value) · Odds ratio (or): 0.53 · 80% CI 0.22 to 1.32
SecondaryPercentage of Participants With Endoscopic Response at Week 8

Endoscopic response is defined as a decrease in modified Baron endoscopic score from baseline of at least 2 points.

Time frame:
Week 8
Reported as:
Number · percentage of participants
Percentage of Participants With Endoscopic Response at Week 8
percentage of participantsCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
Percentage of Participants With Endoscopic Response at Week 8000008.78.010.519.0
Statistical analysis
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Regression, Logistic · p = 0.84 (1-sided p-value) · Odds ratio (or): 0.49 · 80% CI 0.20 to 1.24
SecondaryPercentage of Participants in Clinical Response at Week 8

Clinical response is defined as a decrease in total Mayo score from baseline of at least 3 points and at least 30 percent (%), with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1.

Time frame:
Week 8
Reported as:
Number · percentage of participants
Percentage of Participants in Clinical Response at Week 8
percentage of participantsCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
Percentage of Participants in Clinical Response at Week 850.033.30004.324.015.842.9
Statistical analysis
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Regression, Logistic · p = 0.96 (1-sided p-value) · Odds ratio (or): 0.30 · 80% CI 0.12 to 0.73
SecondaryChange From Baseline in Total Mayo Scores at Week 8

Mayo Score is an instrument designed to measure disease activity of ulcerative colitis, with total score ranging from 0 to 12. It consists of 4 subscores (stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy, and physician global assessment \[PGA\]), each graded from 0 to 3, with higher scores indicating more severe disease.

Time frame:
Baseline, Week 8
Reported as:
Mean · scores on a scale
Change From Baseline in Total Mayo Scores at Week 8
scores on a scaleCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
Baseline (n=2,3,2,4,6,23,25,19,21)10.00 ± 2.8287.33 ± 1.1558.50 ± 0.7077.75 ± 0.9577.50 ± 2.2588.74 ± 1.8398.48 ± 2.1438.47 ± 1.8068.14 ± 2.220
Change at Week 8 (n=2,3,2,3,5,23,25,19,21)-2.00 ± 1.4140.00 ± 2.6461.00 ± 1.4140.33 ± 0.577-0.60 ± 0.894-0.78 ± 2.088-1.20 ± 2.872-0.89 ± 2.132-2.00 ± 2.683
Statistical analysis
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · ANCOVA · p = 0.87 (1-sided p-value) · Mean difference (final values): 0.58 · 80% CI -0.08 to 1.24
SecondaryChange From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16

Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo Score ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease. A Partial Mayo Score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). Higher scores indicate more severe disease.

Time frame:
Baseline, Weeks 4, 8, 12 and 16
Reported as:
Mean · scores on a scale
Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16
scores on a scaleCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
Baseline (n=2,3,2,4,6,23,25,19,21)7.50 ± 2.1215.33 ± 0.5776.00 ± 1.4145.75 ± 0.5005.50 ± 1.3786.22 ± 1.3476.08 ± 1.6056.00 ± 1.2025.71 ± 1.736
Change at Week 4 (n=2,3,2,3,5,23,25,19,21)-3.00 ± 0.000-2.00 ± 1.732-0.50 ± 0.7070.67 ± 1.528-0.40 ± 1.140-1.00 ± 1.414-0.96 ± 1.791-1.16 ± 1.675-1.24 ± 1.895
Change at Week 8 (n=2,3,2,3,5,23,25,19,21)-2.00 ± 1.414-1.00 ± 1.7320.50 ± 0.7070.33 ± 0.577-0.80 ± 1.095-0.91 ± 1.756-1.12 ± 2.472-0.79 ± 1.653-1.62 ± 2.037
Change at Week 12 (n=0,0,0,0,0,22,25,17,19)NA ± NANA ± NANA ± NANA ± NANA ± NA-1.91 ± 1.974-1.52 ± 2.312-2.06 ± 2.135-2.11 ± 2.622
Change at Week 16 (2,3,2,4,5,21,24,17,19)-1.50 ± 0.707-3.00 ± 3.000-1.00 ± 2.828-1.25 ± 3.403-2.20 ± 1.924-1.86 ± 2.081-2.54 ± 2.621-2.41 ± 2.181-2.63 ± 2.033
Statistical analysis
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.80 (1-sided p-value) · Mean difference (final values): 0.29 · 80% CI -0.15 to 0.74MMRM using data up to Week 16
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.77 (1-sided p-value) · Mean difference (final values): 0.30 · 80% CI -0.23 to 0.84MMRM using data up to Week 16
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.74 (1-sided p-value) · Mean difference (final values): 0.44 · 80% CI -0.42 to 1.30MMRM using data up to Week 16
  • Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.88 (1-sided p-value) · Mean difference (final values): 0.76 · 80% CI -0.08 to 1.59MMRM using data up to Week 16
  • Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.72 (1-sided p-value) · Mean difference (final values): 0.42 · 80% CI -0.50 to 1.33MMRM using data up to Week 16
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.97 (1-sided p-value) · Mean difference (final values): 1.21 · 80% CI 0.37 to 2.06MMRM using data up to Week 16
  • Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.75 (1-sided p-value) · Mean difference (final values): 0.43 · 80% CI -0.39 to 1.25MMRM using data up to Week 16
  • Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.85 (1-sided p-value) · Mean difference (final values): 0.73 · 80% CI -0.16 to 1.63MMRM using data up to Week 16
SecondaryChange From Baseline in Biopsy Histology Scores at Week 8

A 15 to 25 centimeter (cm) biopsy sample of inflamed mucosal tissue was taken from the worst affected area and scored using the Riley Index. The Riley Index is a histologic scoring system for the assessment of the activity and severity of ulcerative colitis, ranging from 0 to 24. It consists of 6 histologic features (acute inflammatory cell infiltrate, crypt abscesses, mucin depletion, surface epithelial integrity, chronic inflammatory cell infiltrate, and crypt architectural irregularities), all scored on a 4-point scale (higher scores indicate more severe disease).

Time frame:
Baseline and Week 8
Reported as:
Mean · scores on a scale
Change From Baseline in Biopsy Histology Scores at Week 8
scores on a scaleCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
Baseline(n=2,3,2,4,5,22,24,18,21)9.0 ± 1.419.7 ± 3.7911.0 ± 2.837.0 ± 3.9210.8 ± 3.779.4 ± 4.3710.4 ± 4.249.9 ± 4.179.7 ± 5.14
Change at Week 4 (n=2,3,1,3,5,21,24,15,20)-3.5 ± 4.951.3 ± 1.15-3.0 ± NA-1.0 ± 1.73-0.4 ± 2.071.4 ± 4.63-1.0 ± 3.760.9 ± 4.09-1.5 ± 4.80
Statistical analysis
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · ANCOVA · p = 0.75 (1-sided p-value) · Mean difference (final values): 0.52 · 80% CI -0.46 to 1.49
SecondaryChange From Baseline in Patient-Reported Rectal Bleeding up to Week 16

Patient-reported diary data assessed the number of bowel movements (BM) per day when not having a flare and the presence of blood in the stools (rectal bleeding \[RB\]), if any.

Time frame:
Baseline and Week 16
Reported as:
Mean · scores on a scale
Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16
scores on a scaleCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
BM: Baseline(n=2,3,2,4,6,23,25,19,21)12.50 ± 4.9508.00 ± 2.7846.75 ± 2.47511.75 ± 10.5088.42 ± 3.0897.50 ± 3.4907.78 ± 3.7817.50 ± 3.5716.88 ± 4.886
BM: Change at Week 1 (n=2,3,2,4,5,23,25,19,21)-1.60 ± 2.263-1.89 ± 1.7664.15 ± 2.845-0.60 ± 2.1770.40 ± 1.300-0.42 ± 1.509-0.59 ± 1.657-0.56 ± 1.215-0.81 ± 3.421
BM: Change at Week 4 (n=2,2,2,3,5,23,23,16,19-1.43 ± 3.435-1.89 ± 5.1012.36 ± 0.5050.17 ± 2.0381.31 ± 1.432-0.81 ± 2.0880.28 ± 3.956-0.63 ± 1.856-1.08 ± 2.575
BM: Change at Week 8 (n=2,3,2,3,6,23,23,16,19)-1.67 ± 3.771-0.86 ± 3.5173.18 ± 0.7580.17 ± 2.7540.41 ± 2.131-0.89 ± 2.864-1.15 ± 2.8330.18 ± 2.531-1.41 ± 3.208
BM: Change at Week 12 (n=1,1,1,2,2,21,25,16,18)0.14 ± NA1.43 ± NA1.57 ± NA-1.68 ± 2.3740.00 ± 0.000-0.67 ± 3.152-0.59 ± 4.426-1.77 ± 2.301-2.02 ± 3.502
BM: Change at Week 16 (n=1,3,2,3,4,22,24,16,18)0.00 ± NA-2.51 ± 3.7161.72 ± 0.596-0.12 ± 2.324-2.45 ± 2.208-1.81 ± 3.278-2.17 ± 3.523-1.68 ± 2.899-1.86 ± 3.616
RB: Baseline (n=2,3,2,4,6,23,25,19,21)1.25 ± 1.0611.17 ± 1.2581.00 ± 1.4141.00 ± 0.8161.33 ± 0.8161.20 ± 0.9741.46 ± 0.9780.97 ± 0.9501.05 ± 0.820
RB: Change at Week 1 (n=2,3,2,4,5,23,25,19,21)-0.32 ± 0.253-1.00 ± 1.167-0.33 ± 0.471-0.12 ± 0.158-0.30 ± 0.415-0.36 ± 0.697-0.24 ± 0.605-0.05 ± 0.574-0.10 ± 0.408
RB: Change at Week 4 (n=2,2,2,3,5,23,23,16,19)-0.75 ± 0.354-0.29 ± 1.010-0.25 ± 0.3540.14 ± 0.378-0.71 ± 0.990-0.34 ± 0.883-0.47 ± 0.840-0.27 ± 0.738-0.26 ± 0.604
RB: Change at Week 8 (n=2,3,2,3,6,22,23,13,20)-0.75 ± 0.354-0.50 ± 0.5000.00 ± 0.0000.33 ± 0.577-0.47 ± 1.035-0.40 ± 0.709-0.51 ± 0.805-0.19 ± 0.997-0.51 ± 0.967
RB: Change at Week 12 (n=1,1,1,2,2,21,25,16,18)-0.57 ± NA0.00 ± NA0.00 ± NA0.00 ± 0.0000.00 ± 0.000-0.60 ± 0.792-0.49 ± 1.084-0.48 ± 0.829-0.39 ± 0.783
RB: Change at Week 16 (n=1,3,2,3,4,22,24,16,18)-1.00 ± NA-1.17 ± 1.258-0.10 ± 0.1410.33 ± 0.577-1.14 ± 0.865-0.41 ± 0.936-0.86 ± 1.106-0.41 ± 0.838-0.39 ± 0.874
Statistical analysis
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.51 (1-sided p-value) · Mean difference (final values): 0.00 · 80% CI -0.18 to 0.19MMRM using data up to Week 16
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.62 (1-sided p-value) · Mean difference (final values): 0.05 · 80% CI -0.16 to 0.25MMRM using data up to Week 16
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.29 (1-sided p-value) · Mean difference (final values): -0.12 · 80% CI -0.39 to 0.16MMRM using data up to Week 16
  • Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.74 (1-sided p-value) · Mean difference (final values): 0.13 · 80% CI -0.14 to 0.40MMRM using data up to Week 16
  • Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.36 (1-sided p-value) · Mean difference (final values): -0.08 · 80% CI -0.37 to 0.21MMRM using data up to Week 16
  • Cohort 3: MultiStem 750, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.56 (1-sided p-value) · Mean difference (final values): 0.04 · 80% CI -0.26 to 0.34MMRM using data up to Week 16
  • Cohort 3: MultiStem 750, Placebo vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.18 (1-sided p-value) · Mean difference (final values): -0.21 · 80% CI -0.51 to 0.09MMRM using data up to Week 16
  • Cohort 3: Placebo, MultiStem 750 vs Cohort 3: Placebo, Placebo · Mixed Models Analysis · p = 0.31 (1-sided p-value) · Mean difference (final values): -0.12 · 80% CI -0.45 to 0.20MMRM using data up to Week 16

Adverse events

Collected over Baseline up to 28 days after last study drug administration.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 1: Placebo, MultiStem 300—1/2 (50%)2/2 (100%)
Cohort 2: Placebo, MultiStem 750—0/3 (0%)3/3 (100%)
Cohort 1: MultiStem 300, Placebo—0/2 (0%)0/2 (0%)
Cohort 1: MultiStem 300 (x3), Placebo—3/4 (75%)3/4 (75%)
Cohort 2: MultiStem 750, Placebo—0/6 (0%)5/6 (83.3%)
Cohort 3: MultiStem 750, MultiStem 750—7/23 (30.4%)18/23 (78.3%)
Cohort 3: MultiStem 750, Placebo—4/25 (16%)16/25 (64%)
Cohort 3: Placebo, MultiStem 750—5/19 (26.3%)15/19 (78.9%)
Cohort 3: Placebo, Placebo—4/21 (19%)18/21 (85.7%)
Most frequent serious events
Showing 10 of 20
Most frequent serious events
EventCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
Colitis ulcerativeGastrointestinal disorders1/20/30/21/40/65/231/252/193/21
ColitisGastrointestinal disorders0/20/30/21/40/60/231/250/190/21
HypersensitivityImmune system disorders0/20/30/21/40/60/230/250/190/21
Clostridium difficile infectionInfections and infestations0/20/30/20/40/61/232/251/190/21
PneumoniaInfections and infestations0/20/30/20/40/60/230/251/190/21
EpilepsyNervous system disorders0/20/30/20/40/60/230/251/190/21
Diastolic hypertensionVascular disorders0/20/30/20/40/60/230/251/190/21
Ventricular tachycardiaCardiac disorders0/20/30/20/40/60/230/250/191/21
Clostridium difficile colitisInfections and infestations0/20/30/20/40/60/230/250/191/21
Superior sagittal sinus thrombosisNervous system disorders0/20/30/20/40/60/230/250/191/21
Most frequent other events
Showing 10 of 95
Most frequent other events
EventCohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300, PlaceboCohort 1: MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, Placebo
PyrexiaGeneral disorders0/20/30/23/40/62/232/251/192/21
Abdominal tendernessGastrointestinal disorders1/20/30/20/41/60/230/250/190/21
Gastrooesophageal reflux diseaseGastrointestinal disorders1/20/30/20/40/60/230/250/190/21
Chest discomfortGeneral disorders1/20/30/20/41/60/230/252/191/21
ChillsGeneral disorders0/21/30/22/40/61/230/250/190/21
Influenza like illnessGeneral disorders1/20/30/20/40/61/231/250/190/21
BronchitisInfections and infestations1/20/30/20/40/60/230/250/190/21
InfluenzaInfections and infestations1/20/30/20/40/61/230/251/190/21
CoughRespiratory, thoracic and mediastinal disorders1/21/30/20/40/63/233/250/190/21
DyspnoeaRespiratory, thoracic and mediastinal disorders1/20/30/20/40/61/230/250/191/21

Baseline characteristics

The safety analysis set consisted of all participants who received at least 1 dose of study medication.

Age, Continuous
Age, Continuous(years)Cohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300 or MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, PlaceboTotal
Mean61.0 ± 7.152.0 ± 7.049.3 ± 14.140.0 ± 14.043.4 ± 12.838.8 ± 13.439.8 ± 12.542.5 ± 15.742.2 ± 13.7
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1: Placebo, MultiStem 300Cohort 2: Placebo, MultiStem 750Cohort 1: MultiStem 300 or MultiStem 300 (x3), PlaceboCohort 2: MultiStem 750, PlaceboCohort 3: MultiStem 750, MultiStem 750Cohort 3: MultiStem 750, PlaceboCohort 3: Placebo, MultiStem 750Cohort 3: Placebo, PlaceboTotal
Female01157123736
Male22511613161469
08

Study locations

58 sites
  • University of California San Francisco
    San Francisco, California 94115, United States
  • USCF Endoscopy Unit at Mount Zion
    San Francisco, California 94115, United States
  • Clinical Research of the Rockies
    Lafayette, Colorado 80026, United States
  • Rocky Mountain Gastroenterology Associates, LLC
    Lakewood, Colorado 80215, United States
  • Arapahoe Gastroenterology, PC
    Littleton, Colorado 80120, United States
  • Metropolitan Gastroenterology Group, PC
    Washington D.C., District of Columbia 20006, United States
  • Gastroenterology Consultants of Clearwater
    Clearwater, Florida 33756, United States
  • West Coast Endoscopy Center
    Clearwater, Florida 33756, United States
  • Clinical Research of West Florida, Inc.
    Clearwater, Florida 33765, United States
  • Borland-Groover Clinic
    Jacksonville, Florida 32256, United States
  • Jacksonville Center for Endoscopy
    Jacksonville, Florida 32256, United States
  • Miami Research Associates
    South Miami, Florida 33143, United States
  • University of Chicago Medical Center
    Chicago, Illinois 60637, United States
  • Cotton-O'Neil Clinical Research Center, Digestive Health
    Topeka, Kansas 66606, United States
  • University of Louisville Healthcare Outpatient Center
    Louisville, Kentucky 40202, United States
  • University of Louisville Hospital
    Louisville, Kentucky 40202, United States
  • Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research
    Chevy Chase, Maryland 20815, United States
  • Endoscopic Microsurgery Associates, PA
    Towson, Maryland 21204, United States
  • Clinical Research Institute of Michigan, LLC
    Chesterfield, Michigan 48047, United States
  • Center for Digestive Health
    Troy, Michigan 48098, United States
  • Utica Surgery Center
    Utica, Michigan 48317, United States
  • Surgery Center of Columbia
    Columbia, Missouri 65201, United States
  • Center for Digestive and Liver Diseases, Inc.
    Mexico, Missouri 65265, United States
  • Present, Chapman, Steinlauf and Marion
    New York, New York 10028, United States
  • Mount Sinai School of Medicine
    New York, New York 10029, United States
  • Asher Kornbluth, MD PC
    New York, New York 10128, United States
  • Charlotte Gastroenterology and Hepatology, PLLC
    Charlotte, North Carolina 28207, United States
  • Wake Internal Medicine Consultants, Inc.
    Raleigh, North Carolina 27612, United States
  • Wake Research Associates
    Raleigh, North Carolina 27612, United States
  • Wake Forest University University Baptist Medical Center - Internal Medicine
    Winston-Salem, North Carolina 27157, United States
  • Gastro One
    Germantown, Tennessee 38138, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232-1375, United States
  • Digestive and Liver Disease Specialists
    Norfolk, Virginia 23502, United States
  • Sentara Leigh Hospital
    Norfolk, Virginia 23502, United States
  • Sentara Norfolk General Hospital
    Norfolk, Virginia 23507, United States
  • McGuire DVAMC
    Richmond, Virginia 23249, United States
  • University of Washington Medical Center
    Seattle, Washington 98195, United States
  • Hopital Erasme / Gastroenterology
    Brussels, 1070, Belgium
  • Pfizer Clinical Research Unit
    Brussels, 1070, Belgium
  • University of Alberta Hospital
    Edmonton, Alberta T6G 2B7, Canada
  • Northern Alberta Clinical Trials and Research Center
    Edmonton, Alberta T6G 2C8, Canada
  • Zeidler Ledcor Centre - University of Alberta
    Edmonton, Alberta T6G 2X8, Canada
  • Maisonneuve-Rosemont Hospital
    Montreal, Quebec H1T 2M4, Canada
  • Agaplesion Markus Krankenhaus
    Frankfurt am Main, 60431, Germany
  • Universitaetsklinikum Halle
    Halle, 06120, Germany
  • Medizinische Hochschule Hannover
    Hanover, 30625, Germany
  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia
    Budapest, 1125, Hungary
  • Pandy Kalman Megyei Korhaz, III. sz. Belosztaly-Gasztroenterologia
    Gyula, 5700, Hungary
  • Karolina Korhaz Rendelointezet, Belgyogyaszat
    Mosonmagyaróvár, 9200, Hungary
  • Tolna Megyei Balassa Janos Korhaz / II. Belgyogyaszat
    Szekszárd, 7100, Hungary
  • Azienda Ospedaliera Luigi Sacco
    Milan, 20157, Italy
  • Azienda Ospedaliera di Padova
    Padova, 35128, Italy
  • Policlinico Universitario Agostino Gemelli
    Roma, 00168, Italy
  • Gastroenterologicke a hepatologicke oddelenie, V. interna klinika LFUK a UN Bratislava, Ruzinov
    Bratislava, Slovakia 826 06, Slovakia
  • Gastroenterologicka ambulancia, GEA s.r.o.
    Trnava, 917 01, Slovakia
  • Sahlgrenska Universitetssjukhuset Medicinkliniken
    Gothenburg, 413 45, Sweden
  • Karolinska Universitetssjukhuset, GastroCentrum Medicin
    Stockholm, 171 76, Sweden
  • Akademiska sjukhuset, Mag tarmmottagningen
    Uppsala, 751 85, Sweden
09

References and documents

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2011, a primary completion of Nov 2014 and a completion of Nov 2014. It does not say whether these dates are actual or estimated.

Results were first posted in Feb 2016, 1 year 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 10, 2010
First posted
Nov 15, 2010
Start
Feb 2011
Primary completionActual
Nov 2014
CompletionActual
Nov 2014
Results first posted
Feb 23, 2016
Last update
Feb 23, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01240915
Lead sponsor
Pfizer
Collaborators
Healios K.K.
Responsible party
Sponsor
First posted
Nov 15, 2010
Start date
Feb 2011
Primary completion
Nov 2014
Completion
Nov 2014
Results posted
Feb 23, 2016
Last update
Feb 23, 2016

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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