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CompletedNCT02464878Updated Dec 22, 2023Results posted

Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant

A Phase 2 interventional study of Alpha 1-Antitrypsin and Islet Transplantation in Kidney Transplant and Type 1 Diabetes, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-12-22.

Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Patients meeting the study entry criteria will receive 1-3 infusion(s) of in vitro cultured islets. Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks.

02

Conditions studied

  • Kidney Transplant
  • Type 1 Diabetes
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's enrollment of 2 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male and female subjects age 18 to 70 years.
  • Subjects who are able to provide written informed consent and to comply with the procedures of the study protocol.

  • Subjects must have one of the following payment mechanisms in place:

    1. Medicare,
    2. A third-party insurer who agrees, via pre-authorization, to pay for participation in the study, or
    3. Another mechanism of payment (self-pay, hospital, university, donations, etc.) for participation in the study.
  • Clinical history compatible with T1D with disease onset \< 40 years of age and insulin-dependence for ≥ 5 years at the time of enrollment.
  • Absent stimulated c-peptide (\< 0.3 ng/mL) in response to a MMTT [Boost® 6 mL/kg body weight (BW) to a maximum of 360 mL; another product with equivalent caloric and nutrient content may be substituted for Boost®] measured at 60 and 90 min after start of consumption.
  • Subjects who are ≥ 3 months post-renal transplant who are taking appropriate calcineurin inhibitor (CNI) based maintenance immunosuppression ([tacrolimus alone or in conjunction with sirolimus, mycophenolate mofetil, myfortic, or azathioprine; or cyclosporine in conjunction with sirolimus, mycophenolate mofetil, or myfortic] ± Prednisone ≤ 10 mg/day).
  • Stable renal function as defined by a creatinine of no more than one third greater than the average creatinine determination performed in the 3 previous months prior to islet transplantation, until rejection, obstruction or infection is ruled out.

  • Subjects who meet one of the options in the following criterion are eligible for transplantation:

    • Reduced awareness of hypoglycemia manifested by a Clarke score of 4 or more measured upon study enrollment and at least one episode of severe hypoglycemia in the 12 months prior to study enrollment.
    • A subject must have a reduced awareness of hypoglycemia manifested by a Clarke score of 4 or more and at least 1 episode of severe hypoglycemia;
    • Any subject not meeting the hypoglycemia option must have an HbA1c > 7.5%.

Exclusion criteria

Exclusion Criteria:

  • Weight more than 100 kg or body mass index (BMI) > 33 kg/m2.
  • Insulin requirement of >1.0 U/kg/day or, > 60 U/day total, or \<15 U/day.
  • Other (non-kidney) organ transplants except prior failed pancreatic graft where graft failure is attributed to thrombosis within the first 4 weeks or to other technical reasons that require graft pancreatectomy; with the graft pancreatectomy occurring more than 6 months ago.
  • Untreated or unstable proliferative diabetic retinopathy.
  • Blood Pressure: SBP > 160 mmHg or DBP >100 mmHg despite treatment with antihypertensive agents.

  • Calculated GFR of ≤ 40 mL/min/1.73 m2 using the subject's measured serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation1. Strict vegetarians (vegans) will be excluded only if their estimated GFR is ≤ 35 mL/min/1.73 m2.

    1. Proteinuria (albumin/creatinine ratio or ACr > 300mg/g) of new onset since kidney transplantation.

  • Calculated panel-reactive anti-HLA antibodies > 50%. Subjects with calculated panel reactive anti-HLA antibodies ≤ 50% will be excluded if any of the following are detected:

    • Positive cross-match,
    • Islet donor-directed anti-HLA antibodies detected by Luminex Single Antigen/specificity bead assay including weakly reactive antibodies that would not be detected by a flow cross-match, or
    • Antibodies to the renal donor (i.e. presumed de novo).
  • For female subjects: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. For male subjects: intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.
  • Presence or history of active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB). Subjects with laboratory evidence of active infection are excluded even in the absence of clinical evidence of active infection.
  • Negative screen for Epstein-Barr virus (EBV) by IgG determination at time of screening or previous kidney transplant.
  • Invasive aspergillus, histoplasmosis, and coccidoidomycosis infection within the last year.
  • Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin.
  • Known active alcohol or substance abuse.
  • Any coagulopathy or medical condition requiring long-term anticoagulant therapy (e.g. warfarin) after islet transplantation (low-dose aspirin treatment [325 mg PO] is allowed) or subjects with international normalized ratio (INR) > 1.5. The use of Plavix is allowed only in conjunction with mini- laparotomy procedure at the time of islet transplant.

  • Severe co-existing cardiac disease, characterized by any one of these conditions:

    • Recent MI (within past 6 months);
    • Evidence of ischemia on functional cardiac exam within the last year;
    • Left ventricular ejection fraction \< 30%; or
    • Valvular disease requiring replacement with prosthetic valve.
  • Persistent serum glutamic-oxaloacetic transaminase (SGOT [AST]), serum glutamate pyruvate transaminase (SGPT [ALT],) alkaline phosphatase or total bilirubin, with values > 1.5 times normal upper limits will exclude a subject.
  • Active infections (except mild skin and nail fungal infections).
  • Acute or chronic pancreatitis.
  • Active peptic ulcer disease, symptomatic gallstones, or portal hypertension.
  • Use of any investigational agents within 4 weeks of enrollment.
  • Administration of live attenuated vaccine(s) within 2 months of enrollment.
  • Any medical condition that, in the opinion of the investigator, will interfere with the safe participation in the trial. (Cancer screenings should be performed per current American Cancer Society guidelines).
  • Positive screen for BK virus by polymerase chain reaction (PCR) performed at time of screening.
  • A kidney transplant patient with type 1 diabetes who has an HbA1c \< 7.5 and no history of severe hypoglycemia.
  • Selective or severe IgA deficiency (levels \< 5-7 mg/dL)
  • AAT deficiency (defined as \< 1.0ng/mg AAT)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Other
    Main study treatment

    Drug: Alpha 1-Antitrypsin · Procedure: Islet Transplantation · Drug: Thymoglobulin · Drug: Basiliximab · Drug: Etanercept

Interventions

  • DrugAlpha 1-Antitrypsin

    Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks.

    Also known as: Glassia

  • ProcedureIslet Transplantation
  • DrugThymoglobulin

    Patients will receive a total of 5 doses between Day -2 and Day +2

    Also known as: Antithymocyte Globulin

  • DrugBasiliximab

    Basiliximab will be used for subsequent transplants.

  • DrugEtanercept

    Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.

    Also known as: Enbrel

06

What researchers measure

Primary outcomes

  1. The Proportion of GLASSIA Versus Control CIT06 Subjects Achieving Insulin Independence After First Infusion of Single Donor Islets.

    Insulin Independence examined 75 days after 1st infusion; subject considered to be insulin independent if they are able to titrate off insulin therapy for \<1 week AND all of the following are met: 1. one HbA1c level, one fasting serum glucose level, and a Mixed Meal Tolerance Test (MMTT) documented within the visit window at Day 75 (Day 70-80) and 7 days of blood sugar and insulin readings are documented within +/- 7 days of the visit window (Day 63-87); 2. HbA1c \</= 6.5% or a \>/= 2.5% decrease from baseline (within 91 days prior to transplant); 3. fasting capillary glucose level should not exceed 140 mg/dL more than 3 times in 7 consecutive days; 4. post-prandial serum glucose \</= 180 mg/dL at 90 minutes during MMTT; 5. fasting serum glucose level \</= 126 mg/dL; (6) at least one MMTT fasting or stimulated c-peptide \>/= 0.5 ng/mL

    Time frame: Day 75

Secondary outcomes

  1. The Proportion of GLASSIA Treated Versus Control CIT06 Subjects Who Are Insulin Independent After 1 or More Islet Infusions

    Subject considered to be insulin independent if they are able to titrate off insulin therapy for \<1 week AND all of the following are met: 1. one HbA1c level, one fasting serum glucose level, and a Mixed Meal Tolerance Test (MMTT) documented within the visit window of time frame, noted below, and 7 days of blood sugar and insulin readings are documented within +/- 7 days of the visit window; 2. HbA1c \</= 6.5% or a \>/= 2.5% decrease from baseline (within 91 days prior to transplant); 3. fasting capillary glucose level should not exceed 140 mg/dL more than 3 times in 7 consecutive days; 4. post-prandial serum glucose \</= 180 mg/dL at 90 minutes during MMTT; 5. fasting serum glucose level \</= 126 mg/dL; 6. at least one MMTT fasting or stimulated c-peptide \>/= 0.5 ng/mL

    Time frame: 1 year after the first islet infusion, 1 year after the last islet infusion, 2 years after the first islet infusion, 2 years after the last islet infusion

  2. The Proportion of GLASSIA Treated Versus CIT06 Control Subjects With Both an HbA1c ≤ 6.5% AND an Absence of Severe Hypoglycemic Events

    Number of subjects with both an HbA1c \</= 6.5% and no severe hypoglycemic events at specified timepoints; data utilized for measure were HbA1c levels and number of severe hypoglycemic events.

    Time frame: From Day 28 to Day 365 after the first islet transplant, From Day 28 to Day 730 after the first islet transplant.

  3. The Proportion of GLASSIA Treated Versus Control Subjects With Both an HbA1c < 7.0% AND Free of Severe Hypoglycemic Events

    Subjects with an HbA1c \<7.0% and free of severe hypoglycemic events at specified timepoints; data utilized were HbA1c levels and number/absence of severe hypoglycemic events

    Time frame: From Day 28 to Day 365 after the first islet transplant, From Day 28 to Day 730 after the first islet transplant.

  4. The Proportion of GLASSIA Treated Versus Control CIT06 Subjects A Reduction in HbA1c of 1 Point AND an Absence of Severe Hypoglycemia

    Subjects with a reduction in HbA1c of 1 point and no severe hypoglycemia at specific timepoints. Data utilized were HbA1c numbers at specified timepoints and absence of any severe hypoglycemic events

    Time frame: From Day 28 to Day 365 after the first islet transplant, From Day 28 to Day 730 after the first islet transplant.

  5. The Change in Clarke Score From Baseline in GLASSIA Treated Versus Control CIT06 Subjects

    Clarke Score is a 7 question patient report of hypoglycemia awareness. Answers provide a rating of either A (aware) or R (reduced). Four or more R ratings suggest impaired hypoglycaemia awareness; \< or equal to 2 = normal awareness, 3=borderline. A higher Clarke Score indicates reduced awarness.

    Time frame: 1 year and 2 years after the first islet transplant

  6. The Proportion of Subjects Receiving a Second Islet Transplant Comparing GLASSIA Treated Versus Control CIT06 Subjects

    Subjects requiring a 2nd islet infusion at specified timepoints; data utilized were the number of patients who were not successful at gaining and maintaining insulin independence following the 1st infusion and required a 2nd infusion/transplant of islets.

    Time frame: 1 year and 2 years following the first and last islet transplant(s)

  7. The Proportion of Subjects Receiving a Third Islet Transplant Comparing GLASSIA Treated Versus Control CIT06 Subjects

    Number of subjects requiring a 3rd islet infusion. Data utilized were the number of patients require a 3rd transplant/infusion of islets due to continued requirement of insulin during study participation.

    Time frame: 1 year and 2 years following the first and last islet transplant(s)

  8. Cardiovascular Events [Death, Cerebrovascular Accident (CVA), Myocardial Infarction (MI)] and Changes in Atherogenic Profile for GLASSIA Treated Versus Control Subjects

    Subjects experience of cardiovascular events and changes in atherogenic profile were examined for the timepoints listed below. Data utilized were baseline lipid labs (triglycerides, total cholesterol, HDL, LDL, and Non-HDL Cholesterol) and lipid labs taken at specified timepoints. An improvement would be an overall improvement of the lipid profile (e.g. reduction in non-HDL cholesterol/overall cholesterol, decrease in LDL, increase in HDL, etc.). Due to the COVID-19 pandemic and increased risk faced by transplant/immunosuppressed individuals, some lipid labs were not collected and data has been indicated as NA due to reduction in sample collection/prioritizing safety labs for subjects.

    Time frame: 1 year and 2 years following the first and last islet transplant(s)

07

Results

Posted Dec 22, 2023

Participant flow

Participant flow — Overall Study
MilestoneMain Study Treatment
Started2
Completed2
Not completed0

Outcome measures

PrimaryThe Proportion of GLASSIA Versus Control CIT06 Subjects Achieving Insulin Independence After First Infusion of Single Donor Islets.

Insulin Independence examined 75 days after 1st infusion; subject considered to be insulin independent if they are able to titrate off insulin therapy for \<1 week AND all of the following are met: 1. one HbA1c level, one fasting serum glucose level, and a Mixed Meal Tolerance Test (MMTT) documented within the visit window at Day 75 (Day 70-80) and 7 days of blood sugar and insulin readings are documented within +/- 7 days of the visit window (Day 63-87); 2. HbA1c \</= 6.5% or a \>/= 2.5% decrease from baseline (within 91 days prior to transplant); 3. fasting capillary glucose level should not exceed 140 mg/dL more than 3 times in 7 consecutive days; 4. post-prandial serum glucose \</= 180 mg/dL at 90 minutes during MMTT; 5. fasting serum glucose level \</= 126 mg/dL; (6) at least one MMTT fasting or stimulated c-peptide \>/= 0.5 ng/mL

Time frame:
Day 75
Reported as:
Count of participants · Participants
The Proportion of GLASSIA Versus Control CIT06 Subjects Achieving Insulin Independence After First Infusion of Single Donor Islets.
ParticipantsMain Study Treatment
Ability to titrate of insulin therapy for at least 1 week0
Documented HbA1c, fasting serum glucose level, MMTT, & 7 days blood sugar/insulin readings2
HbA1c ≤ 6.5% or a ≥ 2.5% decrease from baseline (within 91 days prior to transplant)2
Fasting capillary glucose level should not exceed 140 mg/dL more than 3 x in 7 consecutive days1
Post-prandial serum glucose ≤ 180 mg/dL at 90 minutes during the MMTT1
Fasting serum glucose level ≤ 126 mg/dL1
At least one MMTT fasting or stimulated c-peptide ≥ 0.5 ng/mL2
SecondaryThe Proportion of GLASSIA Treated Versus Control CIT06 Subjects Who Are Insulin Independent After 1 or More Islet Infusions

Subject considered to be insulin independent if they are able to titrate off insulin therapy for \<1 week AND all of the following are met: 1. one HbA1c level, one fasting serum glucose level, and a Mixed Meal Tolerance Test (MMTT) documented within the visit window of time frame, noted below, and 7 days of blood sugar and insulin readings are documented within +/- 7 days of the visit window; 2. HbA1c \</= 6.5% or a \>/= 2.5% decrease from baseline (within 91 days prior to transplant); 3. fasting capillary glucose level should not exceed 140 mg/dL more than 3 times in 7 consecutive days; 4. post-prandial serum glucose \</= 180 mg/dL at 90 minutes during MMTT; 5. fasting serum glucose level \</= 126 mg/dL; 6. at least one MMTT fasting or stimulated c-peptide \>/= 0.5 ng/mL

Time frame:
1 year after the first islet infusion, 1 year after the last islet infusion, 2 years after the first islet infusion, 2 years after the last islet infusion
Reported as:
Count of participants · Participants
The Proportion of GLASSIA Treated Versus Control CIT06 Subjects Who Are Insulin Independent After 1 or More Islet Infusions
ParticipantsMain Study Treatment
1 yr after 1st infusion2
1 yr after last infusion1
2 yrs after 1st infusion1
2 yrs after last infusion1
SecondaryThe Proportion of GLASSIA Treated Versus CIT06 Control Subjects With Both an HbA1c ≤ 6.5% AND an Absence of Severe Hypoglycemic Events

Number of subjects with both an HbA1c \</= 6.5% and no severe hypoglycemic events at specified timepoints; data utilized for measure were HbA1c levels and number of severe hypoglycemic events.

Time frame:
From Day 28 to Day 365 after the first islet transplant, From Day 28 to Day 730 after the first islet transplant.
Reported as:
Count of participants · Participants
The Proportion of GLASSIA Treated Versus CIT06 Control Subjects With Both an HbA1c ≤ 6.5% AND an Absence of Severe Hypoglycemic Events
ParticipantsMain Study Treatment
Day 28-365 after 1st infusion2
Day 28-730 after 1st infusion1
SecondaryThe Proportion of GLASSIA Treated Versus Control Subjects With Both an HbA1c < 7.0% AND Free of Severe Hypoglycemic Events

Subjects with an HbA1c \<7.0% and free of severe hypoglycemic events at specified timepoints; data utilized were HbA1c levels and number/absence of severe hypoglycemic events

Time frame:
From Day 28 to Day 365 after the first islet transplant, From Day 28 to Day 730 after the first islet transplant.
Reported as:
Count of participants · Participants
The Proportion of GLASSIA Treated Versus Control Subjects With Both an HbA1c < 7.0% AND Free of Severe Hypoglycemic Events
ParticipantsMain Study Treatment
Day 28-365 after 1st infusion2
Day 28-730 after 1st infusion1
SecondaryThe Proportion of GLASSIA Treated Versus Control CIT06 Subjects A Reduction in HbA1c of 1 Point AND an Absence of Severe Hypoglycemia

Subjects with a reduction in HbA1c of 1 point and no severe hypoglycemia at specific timepoints. Data utilized were HbA1c numbers at specified timepoints and absence of any severe hypoglycemic events

Time frame:
From Day 28 to Day 365 after the first islet transplant, From Day 28 to Day 730 after the first islet transplant.
Reported as:
Count of participants · Participants
The Proportion of GLASSIA Treated Versus Control CIT06 Subjects A Reduction in HbA1c of 1 Point AND an Absence of Severe Hypoglycemia
ParticipantsMain Study Treatment
Day 28-365 after 1st infusion1
Day 28-730 after 1st infusion1
SecondaryThe Change in Clarke Score From Baseline in GLASSIA Treated Versus Control CIT06 Subjects

Clarke Score is a 7 question patient report of hypoglycemia awareness. Answers provide a rating of either A (aware) or R (reduced). Four or more R ratings suggest impaired hypoglycaemia awareness; \< or equal to 2 = normal awareness, 3=borderline. A higher Clarke Score indicates reduced awarness.

Time frame:
1 year and 2 years after the first islet transplant
Reported as:
Count of participants · Participants
The Change in Clarke Score From Baseline in GLASSIA Treated Versus Control CIT06 Subjects
ParticipantsMain Study Treatment
Year 1 after 1st Infusion : Clarke Score improved from Baseline1
Year 1 after 1st Infusion : Clarke Score without improvement from Baseline1
Year 2 after 1st Infusion : Clarke Score improved from Baseline1
Year 2 after 1st Infusion : Clarke Score without improvement from Baseline1
SecondaryThe Proportion of Subjects Receiving a Second Islet Transplant Comparing GLASSIA Treated Versus Control CIT06 Subjects

Subjects requiring a 2nd islet infusion at specified timepoints; data utilized were the number of patients who were not successful at gaining and maintaining insulin independence following the 1st infusion and required a 2nd infusion/transplant of islets.

Time frame:
1 year and 2 years following the first and last islet transplant(s)
Reported as:
Count of participants · Participants
The Proportion of Subjects Receiving a Second Islet Transplant Comparing GLASSIA Treated Versus Control CIT06 Subjects
ParticipantsMain Study Treatment
1 yr after 1st infusion2
1 yr after last infusion2
2 yrs after 1st infusion2
2 yrs after last infusion2
SecondaryThe Proportion of Subjects Receiving a Third Islet Transplant Comparing GLASSIA Treated Versus Control CIT06 Subjects

Number of subjects requiring a 3rd islet infusion. Data utilized were the number of patients require a 3rd transplant/infusion of islets due to continued requirement of insulin during study participation.

Time frame:
1 year and 2 years following the first and last islet transplant(s)
Reported as:
Count of participants · Participants
The Proportion of Subjects Receiving a Third Islet Transplant Comparing GLASSIA Treated Versus Control CIT06 Subjects
ParticipantsMain Study Treatment
1 yr after 1st infusion0
1 yr after last infusion0
2 yrs after 1st infusion0
2 yrs after last infusion0
SecondaryCardiovascular Events [Death, Cerebrovascular Accident (CVA), Myocardial Infarction (MI)] and Changes in Atherogenic Profile for GLASSIA Treated Versus Control Subjects

Subjects experience of cardiovascular events and changes in atherogenic profile were examined for the timepoints listed below. Data utilized were baseline lipid labs (triglycerides, total cholesterol, HDL, LDL, and Non-HDL Cholesterol) and lipid labs taken at specified timepoints. An improvement would be an overall improvement of the lipid profile (e.g. reduction in non-HDL cholesterol/overall cholesterol, decrease in LDL, increase in HDL, etc.). Due to the COVID-19 pandemic and increased risk faced by transplant/immunosuppressed individuals, some lipid labs were not collected and data has been indicated as NA due to reduction in sample collection/prioritizing safety labs for subjects.

Time frame:
1 year and 2 years following the first and last islet transplant(s)
Reported as:
Count of participants · Participants
Cardiovascular Events [Death, Cerebrovascular Accident (CVA), Myocardial Infarction (MI)] and Changes in Atherogenic Profile for GLASSIA Treated Versus Control Subjects
ParticipantsMain Study Treatment
1 yr after 1st infusion — Number of subjects experiencing a cardiovascular event0
1 yr after 1st infusion — Subjects with improvement in Atherogenic Profile at timepoint compared to baselineNA
1 yr after 1st infusion — Subjects with worsening Atherogenic Profile at timepoint compared to baselineNA
1 yr after 1st infusion — Subjects without change to Atherogenic Profile at timepoint compared to baselineNA
1 yr after last infusion — Number of subjects experiencing a cardiovascular event0
1 yr after last infusion — Subjects with improvement in Atherogenic Profile at timepoint compared to baseline1
1 yr after last infusion — Subjects with worsening Atherogenic Profile at timepoint compared to baseline0
1 yr after last infusion — Subjects without change to Atherogenic Profile at timepoint compared to baseline1
2 yrs after 1st infusion — Number of subjects experiencing a cardiovascular event0
2 yrs after 1st infusion — Subjects with improvement in Atherogenic Profile at timepoint compared to baselineNA
2 yrs after 1st infusion — Subjects with worsening Atherogenic Profile at timepoint compared to baselineNA
2 yrs after 1st infusion — Subjects without change to Atherogenic Profile at timepoint compared to baselineNA
2 yrs after last infusion — Number of subjects experiencing a cardiovascular event0
2 yrs after last infusion — Subjects with improvement in Atherogenic Profile at timepoint compared to baseline0
2 yrs after last infusion — Subjects with worsening Atherogenic Profile at timepoint compared to baseline0
2 yrs after last infusion — Subjects without change to Atherogenic Profile at timepoint compared to baseline2

Adverse events

Collected over 2 Years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Main Study Treatment0/2 (0%)1/2 (50%)2/2 (100%)
Most frequent serious events
Most frequent serious events
EventMain Study Treatment
SeizureNervous system disorders1/2
Tounge Swelling (Allergic Reaction)Investigations1/2
Most frequent other events
Showing 10 of 12
Most frequent other events
EventMain Study Treatment
NauseaGastrointestinal disorders2/2
Abdominal Pain/BloatingGastrointestinal disorders1/2
Chest PainCardiac disorders1/2
ConstipationGastrointestinal disorders1/2
DiaphoresisGeneral disorders1/2
DiarrheaGastrointestinal disorders1/2
Elevated CreatinineInfections and infestations1/2
Elevated Liver Function TestsInvestigations1/2
FeverInvestigations1/2
ShinglesInfections and infestations1/2

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Main Study Treatment
<=18 years0
Between 18 and 65 years2
>=65 years0
Age, Continuous
Age, Continuous(years)Main Study Treatment
Mean51 (44 to 58)
Sex: Female, Male
Sex: Female, Male(Participants)Main Study Treatment
Female1
Male1
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Main Study Treatment
Hispanic or Latino0
Not Hispanic or Latino2
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Main Study Treatment
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White2
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Main Study Treatment
United States2
08

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 7, 2017

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02464878
Lead sponsor
Massachusetts General Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Iowa
Responsible party
James F. Markmann, MD, PhD (Chief, Division of Transplant Surgery, Massachusetts General Hospital) — Principal investigator
First posted
Jun 8, 2015
Start date
Jan 2017
Primary completion
Nov 2022
Completion
Dec 2022
Results posted
Dec 22, 2023
Last update
Dec 22, 2023

Study contacts

Jim Markmann, M.D. Ph.D.
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
View the source record on ClinicalTrials.gov ↗

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