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CompletedNCT02013674TridentUpdated Feb 11, 2020Results posted

The TRansendocardial Stem Cell Injection Delivery Effects on Neomyogenesis STudy (The TRIDENT Study)

A Phase 2 interventional study of Allogeneic hMSCs in Chronic Ischemic Left Ventricular Dysfunction and Myocardial Infarction, sponsored by Joshua M Hare. Completed at 1 site in United States. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-02-11.

Sponsored by Joshua M Hare · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
21 Years to 90 Years
Sex
All
01

Study summary

Thirty (30) patients with chronic ischemic left ventricular dysfunction secondary to MI scheduled to undergo cardiac catheterization will be enrolled in the study. This is a phase II study intended to gain additional safety and efficacy assessments among two dose levels previously studied in a phase I setting.

Read the detailed description

Thirty (30) patients with chronic ischemic left ventricular dysfunction secondary to MI scheduled to undergo cardiac catheterization will be enrolled in the study.This is a phase II study intended to gain additional safety and efficacy assessments among two dose levels previously studied in a phase I setting. In this study, a 20 million total hMSC dose and a 100 million total hMSC dose will be randomly allocated administered via the Biocardia Helical infusion system in a blinded manner.

The technique of transplanting progenitor cells into a region of damaged myocardium, termed cellular cardiomyoplasty, is a potentially new therapeutic modality designed to replace or repair necrotic, scarred, or dysfunctional myocardium. Ideally, graft cells should be readily available, easy to culture to ensure adequate quantities for transplantation, and able to survive in host myocardium, which is often a hostile environment of limited blood supply and immunorejection. Whether effective cellular regenerative strategies require that administered cells differentiate into adult cardiomyocytes and couple electromechanically with the surrounding myocardium is increasingly controversial and recent evidence suggests that this may not be required for effective cardiac repair. Most importantly, transplantation of graft cells should improve cardiac function and prevent adverse ventricular remodeling. To date, a number of candidate cells have been transplanted in experimental models, including fetal and neonatal cardiomyocytes, embryonic stem cell-derived myocytes, tissue engineered contractile grafts9, skeletal myoblasts, several cell types derived from adult bone marrow, and cardiac precursors residing within the heart itself. There has been substantial clinical development in the use of whole bone marrow and skeletal myoblast preparations in studies enrolling both post-infarction patients and patients with chronic ischemic left ventricular dysfunction and heart failure. The effects of bone marrow-derived mesenchymal stem cells (MSCs) have also been studied clinically.

Currently, bone marrow or bone marrow-derived cells represent a highly promising modality for cardiac repair. The totality of evidence from trials investigating autologous whole bone marrow infusions into patients following myocardial infarction supports the safety of this approach. In terms of efficacy, increases in ejection fraction are reported in the majority of the trials.

Chronic ischemic left ventricular dysfunction is a common and problematic condition; definitive therapy in the form of heart transplantation is available to only a tiny minority of eligible patients. Cellular cardiomyoplasty for chronic heart failure has been studied less than for acute MI, but represents a potentially important alternative for this disease.

02

Conditions studied

  • Chronic Ischemic Left Ventricular Dysfunction
  • Myocardial Infarction

Keywords

  • Cardiovascular
  • Chronic Ischemic Left Ventricular Dysfunction
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 30 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Joshua M Hare is the lead sponsor of 15 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.

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

04

Who can participate

Ages eligible
21 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • In order to participate in this study, a patient MUST:

    1. Be ≥ 21 and \< 90 years of age.
    2. Provide written informed consent.
    3. Have a diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as defined by previous myocardial infarction documented by an imaging study demonstrating coronary artery disease with corresponding areas of akinesis, dyskinesis, or severe hypokinesis.
    4. Been treated with appropriate maximal medical therapy for heart failure or post-infarction left ventricular dysfunction. For beta-blockade, the patient must have been on a stable dose of a clinically appropriate beta-blocker for 3 months. For angiotensin-converting enzyme inhibition, the patient must have been on a stable dose of a clinically appropriate agent for 1 month.
    5. Be a candidate for cardiac catheterization within 5 to 10 weeks of screening as determined by doctors.
    6. Have an ejection fraction of less than or equal to 50% by gated blood pool scan, two-dimensional echocardiogram, CT, or left ventriculogram within the prior six months and not in the setting of a recent ischemic event.

Exclusion criteria

Exclusion Criteria:

  • In order to participate in this study, a patient MUST NOT:

    1. Have a baseline glomerular filtration rate ≤ 35 ml/min/1.73m2.
    2. Have a known, serious radiographic contrast allergy.
    3. Have a Mechanical aortic valve or heart constrictive device.
    4. Have a documented presence of aortic stenosis (aortic stenosis graded as 1.5cm2 or less).
    5. Have a documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥+2).
    6. Require coronary artery revascularization. Patients who require or undergo revascularization procedures should undergo these procedures a minimum of 3 months in advance of treatment in this study. In addition, patients who develop a need for revascularization following enrollment will be submitted for this therapy without delay.
    7. Have evidence of a life-threatening arrhythmia in the absence of a defibrillator (non-sustained ventricular tachycardia ≥ 20 consecutive beats or complete second or third degree heart block in the absence of a functioning pacemaker) or Corrected for heart rate (QTc) interval > 550 ms on screening ECG
    8. Automatic Implantable Cardioverter Defibrillator (AICD) firing in the past 60 days prior to enrollment.
    9. Have a hematologic abnormality as evidenced by hematocrit \< 25%, white blood cell \< 2,500/µl or platelet values \< 100,000/µl without another explanation.
    10. Have liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the upper limit of normal (ULN).
    11. Have a coagulopathy = (INR > 1.3) not due to a reversible cause (i.e., Coumadin). Patients on Coumadin will be withdrawn 5 days before the procedure and confirmed to have an INR \< 1.3. Patients who cannot be withdrawn from Coumadin will be excluded from enrollment
    12. Have known allergies to penicillin or streptomycin.
    13. Hypersensitivity to Dimethyl Sulfoxide (DMSO).
    14. Be an organ transplant recipient.
    15. Have a history of organ or cell transplant rejection
    16. Have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, melanoma in situ or cervical carcinoma.
    17. Have a non-cardiac condition that limits lifespan to \< 1 year.
    18. Have a history of drug or alcohol abuse within the past 24 months.
    19. Be on chronic therapy with immunosuppressant medication, such as corticosteroids or TNFα antagonists.
    20. Be serum positive for HIV, hepatitis BsAg or viremic hepatitis C.
    21. Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
    22. Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female patients must undergo a blood or urine pregnancy test at screening and within 36 hours prior to injection.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Group 1: 20 million Allogeneic hMSCs

    Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.

    Biological: Allogeneic hMSCs

  • Experimental
    Group 2: 100 million Allogeneic hMSCs

    Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.

    Biological: Allogeneic hMSCs

Interventions

  • BiologicalAllogeneic hMSCs

    Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection

    Also known as: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs)

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment-emergent Serious Adverse Events (SAE).

    Incidence (at one month post-catheterization) of any treatment-emergent serious adverse events, defined as the composite of: death, non-fatal MI, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 15 seconds or with hemodynamic compromise).

    Time frame: One month post-catheterization

Secondary outcomes

  1. Infarct Scar Size (ISS)

    Determined by delayed contrast enhanced Computed Tomography (CT) Scan

    Time frame: Baseline, 12 months

  2. Number of Participant With Reported Tissue Perfusion

    Tissue perfusion measured by CT.

    Time frame: 6 months, 12 months

  3. Peak Oxygen Consumption (VO2)

    Peak VO2 assessed via treadmill determination.

    Time frame: Baseline, 6 months, 12 months

  4. Six-minute Walk Test.

    A test that measures how far a patient can walk in 6 minutes.

    Time frame: Baseline, 3 months, 6 months, 12 months

  5. Changed in New York Heart Association (NYHA) Functional Classification Based on Patient's Self Reported Activity Level.

    Changed in NYHA Functional Classification will be evaluated. Worsened: Documented increase in limitation in physical activity. Improved: Documented decrease in limitation in physical activity. Unchanged: No documented change in limitation in physical activity.

    Time frame: Baseline to 3 months, Baseline to 6 months, Baseline to 12 months

  6. Number of Incidents of Major Adverse Cardiac Events (MACE).

    Incidence of the Major Adverse Cardiac Events (MACE) endpoint, defined as the composite incidence of (1) death, (2) hospitalization for worsening heart failure, or (3) non-fatal recurrent MI.

    Time frame: 1 month, 6 months, 12 months post injection.

  7. Number of Participants With Treatment Emergent Adverse Event (AE)

    Incidence of Treatment Emergent Adverse Event defined as any untoward medical occurrence in a patient or clinical investigation subject temporally associated with the use of the study product.

    Time frame: 6 months, 12 months

  8. Minnesota Living With Heart Failure (MLHF) Questionnaire Scores

    Minnesota Living with Heart Failure (MLHF) Questionnaire has a total score from 0 to 105. A higher score indicates that participant's heart failure is preventing them from living their life.

    Time frame: Baseline, 3 months, 6 months, 12 months

  9. Echocardiographic-derived Measures of Left Ventricular Function

    Left ventricular end diastolic wall thickness as determined by echocardiogram.

    Time frame: 6 months, 12 months

  10. Difference Between Regional Left Ventricular Function (at the Site of Allogeneic Cell Injections)

    As determined by Computed Tomography Scan

    Time frame: Baseline, 12 Months

  11. Difference Between the Regional Left Ventricular Wall Thickening

    As determined by Computed Tomography Scan

    Time frame: Baseline, Month 12

  12. Difference Between Left Ventricular End Diastolic Wall Thickness

    As determined by Computed Tomography Scan

    Time frame: Baseline, 12 Months

  13. Difference Between the Left Ventricular Ejection Fraction (LVEF)

    Change in 1-year LVEF by CT as compared to baseline.

    Time frame: Baseline, 12 months

  14. Difference in LVEF

    As assessed via ECHO

    Time frame: Baseline, 6 months, 12 months

  15. Difference in Left Ventricular Volume

    Difference in left ventricular end diastolic and end systolic volume will be assessed via ECHO

    Time frame: Baseline, 6 months, 12 months

  16. Difference in Left Ventricular Volume

    Difference in left ventricular end diastolic and end systolic volume will be assessed via CT

    Time frame: Baseline, 12 months

  17. Difference in Left Ventricular Regional Myocardial Perfusion

    As measured via myocardial mass by CT

    Time frame: Baseline, 12 months

  18. Number of Participants With Abnormal Electrocardiogram (ECG) Reads.

    The number of participants with abnormal ECG readings via 24 hour ambulatory ECG recordings as assessed per treating physician discretion.

    Time frame: 12 months

  19. Number of Clinically Significant of Abnormal Lab Values.

    Clinical significance of abnormal lab values will be assessed by treating physician

    Time frame: 12 months

  20. Serial Troponin I

    Serial Troponin I values in ng/mL over time.

    Time frame: 12 hours, 24 hours post cardiac catheterization

  21. Number of Participants With Abnormal ECHO Reading

    The number of participants with abnormal reading post-cardiac catheterization. As assessed per treating physician discretion.

    Time frame: 6 hours post cardiac catheterization

  22. Creatinine Kinase Muscle/Brain (CK-MB)

    CK-MB values in ng/mL over time.

    Time frame: 12 hours, 24 hours post cardiac catheterization

07

Results

Posted Feb 5, 2020

Participant flow

Participant flow — Overall Study
MilestoneGroup 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCs
Started1515
Completed1414
Not completed11
Withdrew: Death01
Withdrew: Lost to follow-up10

Outcome measures

PrimaryNumber of Participants With Treatment-emergent Serious Adverse Events (SAE).

Incidence (at one month post-catheterization) of any treatment-emergent serious adverse events, defined as the composite of: death, non-fatal MI, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 15 seconds or with hemodynamic compromise).

Time frame:
One month post-catheterization
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Serious Adverse Events (SAE).
ParticipantsGroup 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCs
Number of Participants With Treatment-emergent Serious Adverse Events (SAE).00
SecondaryInfarct Scar Size (ISS)

Determined by delayed contrast enhanced Computed Tomography (CT) Scan

Time frame:
Baseline, 12 months
Reported as:
Median · Percent of Left Ventricular Mass
Infarct Scar Size (ISS)
Percent of Left Ventricular MassGroup 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCs
Baseline9.9 (6.5 to 16.6)9.7 (6.5 to 12.3)
12 Months6.8 (4.5 to 8.6)5.6 (4.7 to 6.9)
SecondaryNumber of Participant With Reported Tissue Perfusion

Tissue perfusion measured by CT.

Time frame:
6 months, 12 months
Reported as:
Count of participants · Participants
Number of Participant With Reported Tissue Perfusion
ParticipantsGroup 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCs
at 6 months00
at 12 months00
SecondaryPeak Oxygen Consumption (VO2)

Peak VO2 assessed via treadmill determination.

Time frame:
Baseline, 6 months, 12 months
Reported as:
Mean · mL/kg/min
Peak Oxygen Consumption (VO2)
mL/kg/minGroup 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCs
Baseline15.8 ± 5.1516.7 ± 4.48
6 months15.0 ± 5.2716.5 ± 5.30
12 months14.4 ± 4.9416.3 ± 5.84
SecondarySix-minute Walk Test.

A test that measures how far a patient can walk in 6 minutes.

Time frame:
Baseline, 3 months, 6 months, 12 months
Reported as:
Mean · Meters
Six-minute Walk Test.
MetersGroup 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCs
Baseline398.7 ± 111.62434.9 ± 120.04
3 months396.1 ± 109.62433.5 ± 133.97
6 months416.4 ± 107.76453.6 ± 126.82
12 months409.7 ± 130.19463.0 ± 143.07
SecondaryChanged in New York Heart Association (NYHA) Functional Classification Based on Patient's Self Reported Activity Level.

Changed in NYHA Functional Classification will be evaluated. Worsened: Documented increase in limitation in physical activity. Improved: Documented decrease in limitation in physical activity. Unchanged: No documented change in limitation in physical activity.

Time frame:
Baseline to 3 months, Baseline to 6 months, Baseline to 12 months
Reported as:
Count of participants · Participants
Changed in New York Heart Association (NYHA) Functional Classification Based on Patient's Self Reported Activity Level.
ParticipantsGroup 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCs
Baseline to 3 months, Improved24
Baseline to 3 months, Unchanged109
Baseline to 3 months, Worsened32
Baseline to 6 months, Improved54
Baseline to 6 months, Unchanged78
Baseline to 6 months, Worsened22
Baseline to 12 months, Improved56
Baseline to 12 months, Unchanged84
Baseline to 12 months, Worsened14
SecondaryNumber of Incidents of Major Adverse Cardiac Events (MACE).

Incidence of the Major Adverse Cardiac Events (MACE) endpoint, defined as the composite incidence of (1) death, (2) hospitalization for worsening heart failure, or (3) non-fatal recurrent MI.

Time frame:
1 month, 6 months, 12 months post injection.
Reported as:
Number · Incidents
Number of Incidents of Major Adverse Cardiac Events (MACE).
IncidentsGroup 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCs
1 month from injection00
6 months from injection32
12 months from injection32
SecondaryNumber of Participants With Treatment Emergent Adverse Event (AE)

Incidence of Treatment Emergent Adverse Event defined as any untoward medical occurrence in a patient or clinical investigation subject temporally associated with the use of the study product.

Time frame:
6 months, 12 months
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Adverse Event (AE)
ParticipantsGroup 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCs
Treatment emergent AE (6 month)810
Treatment emergent AE (12 months)1013
SecondaryMinnesota Living With Heart Failure (MLHF) Questionnaire Scores

Minnesota Living with Heart Failure (MLHF) Questionnaire has a total score from 0 to 105. A higher score indicates that participant's heart failure is preventing them from living their life.

Time frame:
Baseline, 3 months, 6 months, 12 months
Reported as:
Median · score on a scale
Minnesota Living With Heart Failure (MLHF) Questionnaire Scores
score on a scaleGroup 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCs
Baseline29.0 (21.0 to 52.0)35.0 (6.0 to 60.0)
3 months22.0 (10.0 to 51.0)20.0 (6.0 to 40.0)
6 months30.0 (16.0 to 53.0)21.5 (9.0 to 34.0)
12 months25.0 (4.0 to 41.0)15.0 (8.0 to 64.0)
SecondaryEchocardiographic-derived Measures of Left Ventricular Function

Left ventricular end diastolic wall thickness as determined by echocardiogram.

Time frame:
6 months, 12 months
Reported as:
Median · centimeters (cm)
Echocardiographic-derived Measures of Left Ventricular Function
centimeters (cm)Group 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCs
Month 65.8 (5.2 to 6.3)6.3 (5.7 to 6.6)
Month 126.1 (5.4 to 6.9)6.2 (5.4 to 6.6)
SecondaryDifference Between Regional Left Ventricular Function (at the Site of Allogeneic Cell Injections)

As determined by Computed Tomography Scan

Time frame:
Baseline, 12 Months

No measurements were reported for this outcome.

SecondaryDifference Between the Regional Left Ventricular Wall Thickening

As determined by Computed Tomography Scan

Time frame:
Baseline, Month 12

No measurements were reported for this outcome.

SecondaryDifference Between Left Ventricular End Diastolic Wall Thickness

As determined by Computed Tomography Scan

Time frame:
Baseline, 12 Months

No measurements were reported for this outcome.

SecondaryDifference Between the Left Ventricular Ejection Fraction (LVEF)

Change in 1-year LVEF by CT as compared to baseline.

Time frame:
Baseline, 12 months
Reported as:
Median · Percentage of ejected blood
Difference Between the Left Ventricular Ejection Fraction (LVEF)
Percentage of ejected bloodGroup 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCs
Difference Between the Left Ventricular Ejection Fraction (LVEF)-0.27 (-12.25 to 32.17)3.00 (-8.27 to 10.33)
SecondaryDifference in LVEF

As assessed via ECHO

Time frame:
Baseline, 6 months, 12 months

No measurements were reported for this outcome.

SecondaryDifference in Left Ventricular Volume

Difference in left ventricular end diastolic and end systolic volume will be assessed via ECHO

Time frame:
Baseline, 6 months, 12 months

No measurements were reported for this outcome.

SecondaryDifference in Left Ventricular Volume

Difference in left ventricular end diastolic and end systolic volume will be assessed via CT

Time frame:
Baseline, 12 months
Reported as:
Median · ml
Difference in Left Ventricular Volume
mlGroup 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCs
Difference in Left Ventricular Volume7.65 (-15.89 to 44.76)3.70 (-43.85 to 53.66)
SecondaryDifference in Left Ventricular Regional Myocardial Perfusion

As measured via myocardial mass by CT

Time frame:
Baseline, 12 months

No measurements were reported for this outcome.

SecondaryNumber of Participants With Abnormal Electrocardiogram (ECG) Reads.

The number of participants with abnormal ECG readings via 24 hour ambulatory ECG recordings as assessed per treating physician discretion.

Time frame:
12 months
Reported as:
Count of participants · Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Reads.
ParticipantsGroup 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCs
baseline, normal01
baseline, abnormal not clinically significant1514
baseline, abnormal, clinically significant00
12 months, normal00
12 months, abnormal not clinically significant1214
12 months, abnormal, clinically significant00
SecondaryNumber of Clinically Significant of Abnormal Lab Values.

Clinical significance of abnormal lab values will be assessed by treating physician

Time frame:
12 months

No measurements were reported for this outcome.

SecondarySerial Troponin I

Serial Troponin I values in ng/mL over time.

Time frame:
12 hours, 24 hours post cardiac catheterization
Reported as:
Median · ng/ml
Serial Troponin I
ng/mlGroup 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCs
12-hours post-catheterization0.01 (0.01 to 0.10)0.01 (0.01 to 0.03)
24-hours post-catheterization0.06 (0.01 to 0.29)0.05 (0.01 to 0.18)
SecondaryNumber of Participants With Abnormal ECHO Reading

The number of participants with abnormal reading post-cardiac catheterization. As assessed per treating physician discretion.

Time frame:
6 hours post cardiac catheterization
Reported as:
Count of participants · Participants
Number of Participants With Abnormal ECHO Reading
ParticipantsGroup 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCs
Normal12
Abnormal, Not Clinically Significant66
Abnormal, Clinically Significant00
SecondaryCreatinine Kinase Muscle/Brain (CK-MB)

CK-MB values in ng/mL over time.

Time frame:
12 hours, 24 hours post cardiac catheterization
Reported as:
Median · ng/ml
Creatinine Kinase Muscle/Brain (CK-MB)
ng/mlGroup 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCs
12 hour post catheterization3.25 (1.50 to 27.30)2.45 (1.20 to 6.20)
24 hour post catheterization4.20 (2.40 to 19.30)4.40 (2.40 to 11.10)

Adverse events

Collected over Adverse events are collected over approximately 1 year period.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: 20 Million Allogeneic hMSCs0/15 (0%)4/15 (26.7%)8/15 (53.3%)
Group 2: 100 Million Allogeneic hMSCs1/15 (6.7%)2/15 (13.3%)10/15 (66.7%)
Most frequent serious events
Most frequent serious events
EventGroup 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCs
cardiac failure congestiveCardiac disorders3/151/15
Cardiac failureCardiac disorders2/150/15
Acute coronary syndromeCardiac disorders0/151/15
Myocardial InfarctionCardiac disorders0/151/15
ArterisolerosisVascular disorders0/151/15
HaematomaVascular disorders1/150/15
HypotensionVascular disorders1/150/15
Most frequent other events
Showing 10 of 44
Most frequent other events
EventGroup 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCs
Cardiac failureCardiac disorders4/150/15
Cardiac failure congestiveCardiac disorders3/152/15
HaematuriaRenal and urinary disorders0/153/15
Squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/152/15
DyspnoeaRespiratory, thoracic and mediastinal disorders0/152/15
Acute coronary syndromeCardiac disorders0/151/15
Myocardial InfarctionCardiac disorders0/151/15
Sinus ArrestCardiac disorders1/150/15
VertigoEar and labyrinth disorders1/150/15
Eye pruritusEye disorders0/151/15

Baseline characteristics

Age, Continuous
Age, Continuous(years)Group 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCsTotal
Mean66.8 ± 12.265.6 ± 9.466.2 ± 10.7
Sex: Female, Male
Sex: Female, Male(Participants)Group 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCsTotal
Female303
Male121527
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Group 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCsTotal
Hispanic or Latino235
Not Hispanic or Latino131225
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCsTotal
American Indian or Alaska Native000
Asian011
Native Hawaiian or Other Pacific Islander000
Black or African American101
White141428
More than one race000
Unknown or Not Reported000
Enrollment Ejection Fraction (%)
Enrollment Ejection Fraction (%)(percentage)Group 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCsTotal
Mean31.5 ± 9.926.7 ± 6.529.1 ± 8.6
Enrollment Glomerular Filtration Rate (mL/Min)
Enrollment Glomerular Filtration Rate (mL/Min)(mL/min)Group 1: 20 Million Allogeneic hMSCsGroup 2: 100 Million Allogeneic hMSCsTotal
Mean70.0 ± 24.479.2 ± 20.474.6 ± 22.6
08

Study locations

1 site
  • ISCI / University of Miami
    Miami, Florida 33136, United States
09

References and documents

Publications

  • Florea V, Rieger AC, DiFede DL, El-Khorazaty J, Natsumeda M, Banerjee MN, Tompkins BA, Khan A, Schulman IH, Landin AM, Mushtaq M, Golpanian S, Lowery MH, Byrnes JJ, Hendel RC, Cohen MG, Valasaki K, Pujol MV, Ghersin E, Miki R, Delgado C, Abuzeid F, Vidro-Casiano M, Saltzman RG, DaFonseca D, Caceres LV, Ramdas KN, Mendizabal A, Heldman AW, Mitrani RD, Hare JM. Dose Comparison Study of Allogeneic Mesenchymal Stem Cells in Patients With Ischemic Cardiomyopathy (The TRIDENT Study). Circ Res. 2017 Nov 10;121(11):1279-1290. doi: 10.1161/CIRCRESAHA.117.311827. Epub 2017 Sep 18. PubMed 28923793 ↗

Study documents

  • Protocol and statistical analysis plan · Jun 9, 2016

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

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02013674
Lead sponsor
Joshua M Hare
Collaborators
The Emmes Company, LLC
Responsible party
Joshua M Hare (Chief Science Officer, Director of Interdisciplinary Stem Cell Institute, University of Miami) — Sponsor-investigator
First posted
Dec 17, 2013
Start date
Feb 13, 2014
Primary completion
Mar 2, 2017
Completion
Sep 18, 2017
Results posted
Feb 5, 2020
Last update
Feb 11, 2020

Study contacts

Joshua M Hare, MD
principal investigator · ISCI / University of Miami Miller School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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