Chronic Ischemic Left Ventricular DysfunctionPhase 2TridentNCT02013674
The TRansendocardial Stem Cell Injection Delivery Effects on Neomyogenesis STudy (The TRIDENT Study)
A Phase 2 study testing Allogeneic hMSCs in people with Chronic Ischemic Left Ventricular Dysfunction and Myocardial Infarction, run by Joshua M Hare at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Chronic Ischemic Left Ventricular Dysfunction, Myocardial Infarction
- What is being tested?
- Allogeneic hMSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2014to 18 Sep 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to participate in this study, a patient MUST:
- Be ≥ 21 and < 90 years of age.
- Provide written informed consent.
- 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.
- 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.
- Be a candidate for cardiac catheterization within 5 to 10 weeks of screening as determined by doctors.
- 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.
Who cannot join
- In order to participate in this study, a patient MUST NOT:
- Have a baseline glomerular filtration rate ≤ 35 ml/min/1.73m2.
- Have a known, serious radiographic contrast allergy.
- Have a Mechanical aortic valve or heart constrictive device.
- Have a documented presence of aortic stenosis (aortic stenosis graded as 1.5cm2 or less).
- Have a documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥+2).
Show all 23Show fewer
- 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.
- 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
- Automatic Implantable Cardioverter Defibrillator (AICD) firing in the past 60 days prior to enrollment.
- Have a hematologic abnormality as evidenced by hematocrit < 25%, white blood cell < 2,500/µl or platelet values < 100,000/µl without another explanation.
- Have liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the upper limit of normal (ULN).
- 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
- Have known allergies to penicillin or streptomycin.
- Hypersensitivity to Dimethyl Sulfoxide (DMSO).
- Be an organ transplant recipient.
- Have a history of organ or cell transplant rejection
- 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.
- Have a non-cardiac condition that limits lifespan to < 1 year.
- Have a history of drug or alcohol abuse within the past 24 months.
- Be on chronic therapy with immunosuppressant medication, such as corticosteroids or TNFα antagonists.
- Be serum positive for HIV, hepatitis BsAg or viremic hepatitis C.
- Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Randomized, Blinded, Study of the Safety and Efficacy of Transendocardial Injection of Allogeneic Human Mesenchymal Stem Cells (hMSCs) (20 Million or 100 Million Total MSCs) in Patients With Chronic Ischemic Left Ventricular Dysfunction Secondary to Myocardial Infarction.
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.
- Being tested
- Allogeneic hMSCs
- Keywords
- Cardiovascular, Chronic Ischemic Left Ventricular Dysfunction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic hMSCsBiological
Also called Allogeneic Adult Human Mesenchymal Stem Cells (MSCs)
Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 20 million Allogeneic hMSCs | Experimental | 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. Receives: Biological: Allogeneic hMSCs |
| Group 2: 100 million Allogeneic hMSCs | Experimental | 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. Receives: Biological: Allogeneic hMSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: One month post-catheterization
Secondary outcomes (22)
Infarct Scar Size (ISS)
Determined by delayed contrast enhanced Computed Tomography (CT) Scan
Measured: Baseline, 12 months
Number of Participant With Reported Tissue Perfusion
Tissue perfusion measured by CT.
Measured: 6 months, 12 months
Peak Oxygen Consumption (VO2)
Peak VO2 assessed via treadmill determination.
Measured: Baseline, 6 months, 12 months
Six-minute Walk Test.
A test that measures how far a patient can walk in 6 minutes.
Measured: Baseline, 3 months, 6 months, 12 months
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.
Measured: Baseline to 3 months, Baseline to 6 months, Baseline to 12 months
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.
Measured: 1 month, 6 months, 12 months post injection.
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.
Measured: 6 months, 12 months
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.
Measured: Baseline, 3 months, 6 months, 12 months
Echocardiographic-derived Measures of Left Ventricular Function
Left ventricular end diastolic wall thickness as determined by echocardiogram.
Measured: 6 months, 12 months
Difference Between Regional Left Ventricular Function (at the Site of Allogeneic Cell Injections)
As determined by Computed Tomography Scan
Measured: Baseline, 12 Months
Difference Between the Regional Left Ventricular Wall Thickening
As determined by Computed Tomography Scan
Measured: Baseline, Month 12
Difference Between Left Ventricular End Diastolic Wall Thickness
As determined by Computed Tomography Scan
Measured: Baseline, 12 Months
Difference Between the Left Ventricular Ejection Fraction (LVEF)
Change in 1-year LVEF by CT as compared to baseline.
Measured: Baseline, 12 months
Difference in LVEF
As assessed via ECHO
Measured: Baseline, 6 months, 12 months
Difference in Left Ventricular Volume
Difference in left ventricular end diastolic and end systolic volume will be assessed via ECHO
Measured: Baseline, 6 months, 12 months
Difference in Left Ventricular Volume
Difference in left ventricular end diastolic and end systolic volume will be assessed via CT
Measured: Baseline, 12 months
Difference in Left Ventricular Regional Myocardial Perfusion
As measured via myocardial mass by CT
Measured: Baseline, 12 months
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.
Measured: 12 months
Number of Clinically Significant of Abnormal Lab Values.
Clinical significance of abnormal lab values will be assessed by treating physician
Measured: 12 months
Serial Troponin I
Serial Troponin I values in ng/mL over time.
Measured: 12 hours, 24 hours post cardiac catheterization
Number of Participants With Abnormal ECHO Reading
The number of participants with abnormal reading post-cardiac catheterization. As assessed per treating physician discretion.
Measured: 6 hours post cardiac catheterization
Creatinine Kinase Muscle/Brain (CK-MB)
CK-MB values in ng/mL over time.
Measured: 12 hours, 24 hours post cardiac catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study start13 Feb 2014
- Primary completion2 Mar 2017
- Study completion18 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Ischemic Left Ventricular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joshua M Hare
- Sponsor type
- University, hospital or other
- Collaborators
- The Emmes Company, LLC
- Responsible party
- Sponsor-investigator, Joshua M Hare, University of Miami
- Investigators
- Joshua M Hare, MD, Principal investigator, ISCI / University of Miami Miller School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013674
- Sponsor's protocol ID
- 20120660
- Acronym
- Trident
- Status last verified
- Feb 2020
- First submitted
- 2 Dec 2013
- Last updated
- 11 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Blinded, Study of the Safety and Efficacy of Transendocardial Injection of Allogeneic Human Mesenchymal Stem Cells (hMSCs) (20 Million or 100 Million Total MSCs) in Patients With Chronic Ischemic Left Ventricular Dysfunction Secondary to Myocardial Infarction.
- ClinicalTrials.gov ID
- NCT02013674
- Acronym / sponsor ID
- Trident / 20120660
- Keywords
- Cardiovascular, Chronic Ischemic Left Ventricular Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Joshua M HareUniversity, hospital or other
- Collaborators
- The Emmes Company, LLC
- Study start
- 13 Feb 2014 (actual)
- Primary completion
- 2 Mar 2017 (actual)
- Study completion
- 18 Sep 2017 (actual)
- First posted
- 17 Dec 2013 (estimated)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: 20 million Allogeneic hMSCs | Experimental | Biological: Allogeneic hMSCsFifteen (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. |
| Group 2: 100 million Allogeneic hMSCs | Experimental | Biological: Allogeneic hMSCsFifteen (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. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- In order to participate in this study, a patient MUST:
Key exclusion criteria (23 listed)
- In order to participate in this study, a patient MUST NOT:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic hMSCsAlso: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs)Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection | Biological | Group 1: 20 million Allogeneic hMSCs, Group 2: 100 million Allogeneic hMSCs |
Primary outcome
Number of Participants With Treatment-emergent Serious Adverse Events (SAE).
Time frame: One month post-catheterization
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).
22 secondary outcomes
Infarct Scar Size (ISS)
Time frame: Baseline, 12 months
Number of Participant With Reported Tissue Perfusion
Time frame: 6 months, 12 months
Peak Oxygen Consumption (VO2)
Time frame: Baseline, 6 months, 12 months
Six-minute Walk Test.
Time frame: Baseline, 3 months, 6 months, 12 months
Changed in New York Heart Association (NYHA) Functional Classification Based on Patient's Self Reported Activity Level.
Time frame: Baseline to 3 months, Baseline to 6 months, Baseline to 12 months
Number of Incidents of Major Adverse Cardiac Events (MACE).
Time frame: 1 month, 6 months, 12 months post injection.
Number of Participants With Treatment Emergent Adverse Event (AE)
Time frame: 6 months, 12 months
Minnesota Living With Heart Failure (MLHF) Questionnaire Scores
Time frame: Baseline, 3 months, 6 months, 12 months
Echocardiographic-derived Measures of Left Ventricular Function
Time frame: 6 months, 12 months
Difference Between Regional Left Ventricular Function (at the Site of Allogeneic Cell Injections)
Time frame: Baseline, 12 Months
Difference Between the Regional Left Ventricular Wall Thickening
Time frame: Baseline, Month 12
Difference Between Left Ventricular End Diastolic Wall Thickness
Time frame: Baseline, 12 Months
Difference Between the Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline, 12 months
Difference in LVEF
Time frame: Baseline, 6 months, 12 months
Difference in Left Ventricular Volume
Time frame: Baseline, 6 months, 12 months
Difference in Left Ventricular Volume
Time frame: Baseline, 12 months
Difference in Left Ventricular Regional Myocardial Perfusion
Time frame: Baseline, 12 months
Number of Participants With Abnormal Electrocardiogram (ECG) Reads.
Time frame: 12 months
Number of Clinically Significant of Abnormal Lab Values.
Time frame: 12 months
Serial Troponin I
Time frame: 12 hours, 24 hours post cardiac catheterization
Number of Participants With Abnormal ECHO Reading
Time frame: 6 hours post cardiac catheterization
Creatinine Kinase Muscle/Brain (CK-MB)
Time frame: 12 hours, 24 hours post cardiac catheterization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28923793Florea 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.
- Interdisciplinary Stem Cell Institute at the University of Miami Miller School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua M Hare, MD principal investigator
ISCI / University of Miami Miller School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allogeneic hMSCs in people with Chronic Ischemic Left Ventricular Dysfunction and Myocardial Infarction, run by Joshua M Hare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Serious Adverse Events (SAE). (time frame: One month post-catheterization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02013674, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.