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Transendocardial Injection of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy (DCMII)

Primary Purpose

Non-ischemic Dilated Cardiomyopathy

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
allogeneic human mesenchymal stem cells (hMSCs)
Placebo
Sponsored by
Joshua M Hare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-ischemic Dilated Cardiomyopathy focused on measuring Allogeneic mesenchymal stem cells, Bone marrow-derived mesenchymal stem cells

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Men and women aged 18 to 80 years (inclusive) at the time of signing the informed consent form.
  2. Diagnosis of NIDCM with left ventricular ejection fraction ≤45%.
  3. Appropriate guideline-directed optimal medical therapy for non-ischemic cardiomyopathy. At a minimum, subjects must be on beta blockers and angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) or Angiotensin Receptor Neprilysin Inhibitors (ARNI) or have appropriate medical indication precluding use of one or both of these agents. Subjects must be on a stable regimen for at least 30 days prior to the procedure. Dose titration is allowed.
  4. Be a candidate for cardiac catheterization.
  5. Be willing to undergo DNA test.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Be eligible for or require standard-of-care surgical or percutaneous intervention for the treatment of non-ischemic dilated cardiomyopathy
  2. Clinical manifestation of coronary artery disease (CAD) (e.g., chest pain and concomitant clinical findings such as electrocardiogram changes suggestive of coronary ischemia, myocardial infarction) or evidence of endocardial or transmural scar on cardiac MRI suggestive of undiagnosed CAD or history of percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). Be indicated for or require coronary artery revascularization
  3. Documented presence of epicardial stenosis of 70% or greater in one or more major epicardial coronary arteries
  4. Valvular heart disease including 1) aortic valve prosthesis, mechanical mitral valve, and mitral valve clip; 2) severe aortic valve insufficiency/regurgitation within 12 months of consent
  5. Aortic stenosis with valve area ≤ 1.5cm2
  6. Cardiomyopathy due to acute Post-partum (within 6 months), Non-compaction, or Hypertrophic cardiomyopathy
  7. Cardiomyopathy due to known toxin (e.g amyloid) Note: anthracycline induced cardiomyopathy will be allowed
  8. QTc interval > 550 ms on baseline electrocardiogram (ECG) (note: QTc interval is the interval between the start of the Q wave and the end of the T wave in the heart's electrical cycle)
  9. Automated Implantable Cardioverter Defibrillator (AICD) appropriate firing or anti tachycardia pacing for ventricular tachycardia or ventricular fibrillation within 30 days prior to consent
  10. Have an estimated baseline glomerular filtration rate below the clinical site's institutional cutoff
  11. A hematologic abnormality during baseline testing as evidenced by hemoglobin < 9 g/dl; hematocrit < 30%; absolute neutrophil count < 2,000 or total WBC count more than 2 times upper limit of normal; or platelet values < 100,000/ul
  12. Have liver dysfunction, as evidenced by enzymes Aspartate Transaminase Enzyme (AST) and Alanine Aminotransferase Enzyme (ALT) greater than three times the ULN
  13. Have a bleeding diathesis or coagulopathy (International Normalised Ratio (INR) > 1.5), cannot be withdrawn from anticoagulation therapy, or will refuse blood transfusions
  14. Be a solid organ transplant recipient. This does not include prior cell based therapy (>12 months prior to enrollment), bone, skin, ligament, tendon or corneal grafting.
  15. Have a history of organ or cell transplant rejection
  16. Have a clinical history of malignancy within the past 12 months (i.e., subjects with prior malignancy must be disease free for 12 months), except curatively treated basal cell or squamous cell carcinoma or cervical carcinoma
  17. Drug and/or alcohol abuse or dependence within the past 9 months
  18. Be serum positive for HIV, hepatitis B surface antigen, or viremic hepatitis C
  19. Documented presence of a known Left Ventricular (LV) thrombus, aortic dissection, or aortic aneurysm. (Refer to "Guidance to the PI" section with regards to LV thrombus, below)
  20. Blood glucose levels (HbA1c) >10%
  21. Severe radiographic contrast allergy
  22. Known history of anaphylactic reaction to penicillin or streptomycin
  23. Hypersensitivity to dimethyl sulfoxide (DMSO)
  24. Non-cardiac condition with life expectancy < 1 year
  25. Acute stroke or transient ischemic attack within 3 months of enrollment
  26. Be pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods
  27. Pacemaker-dependence with an Implantable Cardioverter Defibrillator (ICD) (Note: pacemaker-dependent candidates without an ICD are not excluded)
  28. Presence of a pacemaker and/or ICD generator with any of the following limitations/conditions:

    • manufactured before the year 2000
    • leads implanted < 6 weeks prior to consent
    • non-transvenous epicardial or abandoned leads
    • subcutaneous ICDs
    • leadless pacemakers
  29. A cardiac resynchronization therapy (CRT) device implanted less than 3 months prior to consent
  30. Other MRI contraindications (e.g. subject body habitus incompatible with MRI)
  31. Need for advanced heart failure therapy (e.g. IV inotropes)
  32. Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial
  33. Any other condition that in the judgment of the Investigator would be a contraindication to enrollment or follow-up

Sites / Locations

  • Stanford UniversityRecruiting
  • University of Miami Miller School of MedicineRecruiting
  • University of LouisvilleRecruiting
  • Texas Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Genotype A administered with placebo Group

Genotype A administered with hMSC Group

Genotype B administered with placebo Group

Genotype B administered with hMSC Group

Genotype C administered with placebo Group

Genotype C administered with hMSC Group

Arm Description

Participants whose blood genotyping resulted with Genotype A (absence of any variant/ presence of benign variant) and randomized to the placebo group will receive the placebo intervention.

Participants whose blood genotyping resulted with Genotype A (absence of any variant/ presence of benign variant) and randomized to the treatment group will receive the hMSC intervention.

Participants whose blood genotyping resulted with Genotype B (variants of uncertain significance) and randomized to the placebo group will receive the placebo intervention.

Participants whose blood genotyping resulted with Genotype B (variants of uncertain significance) and randomized to the treatment group will receive the hMSC intervention.

Participants whose blood genotyping resulted with Genotype C (pathogenic or likely pathogenic variants) and randomized to the placebo group will receive the placebo intervention.

Participants whose blood genotyping resulted with Genotype C (pathogenic or likely pathogenic variants) and randomized to the treatment group will receive the hMSC intervention.

Outcomes

Primary Outcome Measures

Change in LVEF
Change in Left Ventricular Ejection Fraction (LVEF) as assessed via cardiac Magnetic Resonance Imaging (MRI)

Secondary Outcome Measures

Change in global ventricular strain
Change in global ventricular strain as assessed via cardiac Harmonic Phase (HARP) MRI
Change in left regional strain
Change in regional ventricular strain as assessed via cardiac HARP MRI
Left ventricular function concordance
The left ventricular function concordance will be measured as the Number of individuals who experienced an increase in left ventricular ejection fraction (LVEF) and a simultaneous decrease in both left ventricular end systolic volume index (LVESVI) and left ventricular end diastolic volume index (LVEDVI)
Change in LVEDVI
Change in left ventricular end diastolic index (LVEDVI) as assessed via cardiac MRI
Change in LVESVI
Change in left ventricular end systolic index (LVESVI) as assessed via cardiac MRI
Change in Maximal oxygen consumption (peak VO2)
Change in maximal oxygen consumption (peak VO2) as assessed via treadmill
Change in Exercise tolerance
Change in exercise tolerance as assessed as the distance covered via the six-minute walk test
Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Score
Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a 21-item questionnaire with a total score ranging from 0 to 105 with lower scores indicative of better outcome.
Change in New York Heart Association (NYHA) Class
NYHA Classifications of heart failure are as follows: Class I (no limitations); Class II (mild symptoms); Class III (marked limitations); Class IV (Severe limitations)
Percent change in flow mediated diameter
Change in endothelial function will be reported as the percent change in flow mediated diameter assessed via flow mediated dilation (FMD).
Change in EPC-CFU
Change in endothelial function will be reported as the change in Endothelial Progenitor Cell Colony Forming Unit (EPC-CFU) assessed via blood sample assay
Change in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
Change in NT-proBNP as assessed via blooddraw
Change in cytokines
Change in NT-proBNP as assessed via blooddraw
Incidence of MACE
Safety will be reported as the incidence of Major Adverse Cardiac Events (MACE) assessed by treating physician
Incidence of TE-SAEs
Safety will be reported as the incidence of Treatment Emergent Serious Adverse Events (TE-SAEs) assessed by treating physician

Full Information

First Posted
July 15, 2020
Last Updated
May 11, 2023
Sponsor
Joshua M Hare
Collaborators
United States Department of Defense, The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT04476901
Brief Title
Transendocardial Injection of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy
Acronym
DCMII
Official Title
A Phase IIB Randomized, Placebo-Controlled, Multicenter Study of the Comparative Efficacy and Safety of Transendocardial Injection of Allogeneic-MSC Versus Placebo in Patients With Non- Ischemic Dilated Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 7, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joshua M Hare
Collaborators
United States Department of Defense, The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called human allogeneic mesenchymal stem cell therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-ischemic Dilated Cardiomyopathy
Keywords
Allogeneic mesenchymal stem cells, Bone marrow-derived mesenchymal stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Genotype A administered with placebo Group
Arm Type
Placebo Comparator
Arm Description
Participants whose blood genotyping resulted with Genotype A (absence of any variant/ presence of benign variant) and randomized to the placebo group will receive the placebo intervention.
Arm Title
Genotype A administered with hMSC Group
Arm Type
Experimental
Arm Description
Participants whose blood genotyping resulted with Genotype A (absence of any variant/ presence of benign variant) and randomized to the treatment group will receive the hMSC intervention.
Arm Title
Genotype B administered with placebo Group
Arm Type
Placebo Comparator
Arm Description
Participants whose blood genotyping resulted with Genotype B (variants of uncertain significance) and randomized to the placebo group will receive the placebo intervention.
Arm Title
Genotype B administered with hMSC Group
Arm Type
Experimental
Arm Description
Participants whose blood genotyping resulted with Genotype B (variants of uncertain significance) and randomized to the treatment group will receive the hMSC intervention.
Arm Title
Genotype C administered with placebo Group
Arm Type
Placebo Comparator
Arm Description
Participants whose blood genotyping resulted with Genotype C (pathogenic or likely pathogenic variants) and randomized to the placebo group will receive the placebo intervention.
Arm Title
Genotype C administered with hMSC Group
Arm Type
Experimental
Arm Description
Participants whose blood genotyping resulted with Genotype C (pathogenic or likely pathogenic variants) and randomized to the treatment group will receive the hMSC intervention.
Intervention Type
Biological
Intervention Name(s)
allogeneic human mesenchymal stem cells (hMSCs)
Intervention Description
allo-hMSCs, 16-20 million cells/ml delivered at a dose of 0.5 ml/ injection x 10 injections for a total of 80-100 million allo-hMSCs
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered as injections of plasmalyte A supplemented with 1% of 25% human serum albumin (HSA). 0.5 ml/ injection x 10 injections
Primary Outcome Measure Information:
Title
Change in LVEF
Description
Change in Left Ventricular Ejection Fraction (LVEF) as assessed via cardiac Magnetic Resonance Imaging (MRI)
Time Frame
Baseline, 12 months
Secondary Outcome Measure Information:
Title
Change in global ventricular strain
Description
Change in global ventricular strain as assessed via cardiac Harmonic Phase (HARP) MRI
Time Frame
Baseline, 12 months
Title
Change in left regional strain
Description
Change in regional ventricular strain as assessed via cardiac HARP MRI
Time Frame
Baseline, 12 months
Title
Left ventricular function concordance
Description
The left ventricular function concordance will be measured as the Number of individuals who experienced an increase in left ventricular ejection fraction (LVEF) and a simultaneous decrease in both left ventricular end systolic volume index (LVESVI) and left ventricular end diastolic volume index (LVEDVI)
Time Frame
12 months
Title
Change in LVEDVI
Description
Change in left ventricular end diastolic index (LVEDVI) as assessed via cardiac MRI
Time Frame
Baseline, 12 months
Title
Change in LVESVI
Description
Change in left ventricular end systolic index (LVESVI) as assessed via cardiac MRI
Time Frame
Baseline, 12 months
Title
Change in Maximal oxygen consumption (peak VO2)
Description
Change in maximal oxygen consumption (peak VO2) as assessed via treadmill
Time Frame
Baseline, 12 months
Title
Change in Exercise tolerance
Description
Change in exercise tolerance as assessed as the distance covered via the six-minute walk test
Time Frame
Baseline, 12 months
Title
Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Score
Description
Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a 21-item questionnaire with a total score ranging from 0 to 105 with lower scores indicative of better outcome.
Time Frame
Baseline, 12 months
Title
Change in New York Heart Association (NYHA) Class
Description
NYHA Classifications of heart failure are as follows: Class I (no limitations); Class II (mild symptoms); Class III (marked limitations); Class IV (Severe limitations)
Time Frame
Baseline, 12 months
Title
Percent change in flow mediated diameter
Description
Change in endothelial function will be reported as the percent change in flow mediated diameter assessed via flow mediated dilation (FMD).
Time Frame
Baseline, 12 months
Title
Change in EPC-CFU
Description
Change in endothelial function will be reported as the change in Endothelial Progenitor Cell Colony Forming Unit (EPC-CFU) assessed via blood sample assay
Time Frame
Baseline, 12 months
Title
Change in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
Description
Change in NT-proBNP as assessed via blooddraw
Time Frame
Baseline, 12 months
Title
Change in cytokines
Description
Change in NT-proBNP as assessed via blooddraw
Time Frame
Baseline, 12 months
Title
Incidence of MACE
Description
Safety will be reported as the incidence of Major Adverse Cardiac Events (MACE) assessed by treating physician
Time Frame
12 months
Title
Incidence of TE-SAEs
Description
Safety will be reported as the incidence of Treatment Emergent Serious Adverse Events (TE-SAEs) assessed by treating physician
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: Men and women aged 18 to 80 years (inclusive) at the time of signing the informed consent form. Diagnosis of NIDCM with left ventricular ejection fraction ≤45%. Appropriate guideline-directed optimal medical therapy for non-ischemic cardiomyopathy. At a minimum, subjects must be on beta blockers and angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) or Angiotensin Receptor Neprilysin Inhibitors (ARNI) or have appropriate medical indication precluding use of one or both of these agents. Subjects must be on a stable regimen for at least 30 days prior to the procedure. Dose titration is allowed. Be a candidate for cardiac catheterization. Be willing to undergo DNA test. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: Be eligible for or require standard-of-care surgical or percutaneous intervention for the treatment of non-ischemic dilated cardiomyopathy Clinical manifestation of coronary artery disease (CAD) (e.g., chest pain and concomitant clinical findings such as electrocardiogram changes suggestive of coronary ischemia, myocardial infarction) or evidence of endocardial or transmural scar on cardiac MRI suggestive of undiagnosed CAD or history of percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). Be indicated for or require coronary artery revascularization Documented presence of epicardial stenosis of 70% or greater in one or more major epicardial coronary arteries Valvular heart disease including 1) aortic valve prosthesis, mechanical mitral valve, and mitral valve clip; 2) severe aortic valve insufficiency/regurgitation within 12 months of consent Aortic stenosis with valve area ≤ 1.5cm2 Cardiomyopathy due to acute Post-partum (within 6 months), Non-compaction, or Hypertrophic cardiomyopathy Cardiomyopathy due to known toxin (e.g amyloid) Note: anthracycline induced cardiomyopathy will be allowed QTc interval > 550 ms on baseline electrocardiogram (ECG) (note: QTc interval is the interval between the start of the Q wave and the end of the T wave in the heart's electrical cycle) Automated Implantable Cardioverter Defibrillator (AICD) appropriate firing or anti tachycardia pacing for ventricular tachycardia or ventricular fibrillation within 30 days prior to consent Have an estimated baseline glomerular filtration rate below the clinical site's institutional cutoff A hematologic abnormality during baseline testing as evidenced by hemoglobin < 9 g/dl; hematocrit < 30%; absolute neutrophil count < 2,000 or total WBC count more than 2 times upper limit of normal; or platelet values < 100,000/ul Have liver dysfunction, as evidenced by enzymes Aspartate Transaminase Enzyme (AST) and Alanine Aminotransferase Enzyme (ALT) greater than three times the ULN Have a bleeding diathesis or coagulopathy (International Normalised Ratio (INR) > 1.5), cannot be withdrawn from anticoagulation therapy, or will refuse blood transfusions Be a solid organ transplant recipient. This does not include prior cell based therapy (>12 months prior to enrollment), bone, skin, ligament, tendon or corneal grafting. Have a history of organ or cell transplant rejection Have a clinical history of malignancy within the past 12 months (i.e., subjects with prior malignancy must be disease free for 12 months), except curatively treated basal cell or squamous cell carcinoma or cervical carcinoma Drug and/or alcohol abuse or dependence within the past 9 months Be serum positive for HIV, hepatitis B surface antigen, or viremic hepatitis C Documented presence of a known Left Ventricular (LV) thrombus, aortic dissection, or aortic aneurysm. (Refer to "Guidance to the PI" section with regards to LV thrombus, below) Blood glucose levels (HbA1c) >10% Severe radiographic contrast allergy Known history of anaphylactic reaction to penicillin or streptomycin Hypersensitivity to dimethyl sulfoxide (DMSO) Non-cardiac condition with life expectancy < 1 year Acute stroke or transient ischemic attack within 3 months of enrollment Be pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods Pacemaker-dependence with an Implantable Cardioverter Defibrillator (ICD) (Note: pacemaker-dependent candidates without an ICD are not excluded) Presence of a pacemaker and/or ICD generator with any of the following limitations/conditions: manufactured before the year 2000 leads implanted < 6 weeks prior to consent non-transvenous epicardial or abandoned leads subcutaneous ICDs leadless pacemakers A cardiac resynchronization therapy (CRT) device implanted less than 3 months prior to consent Other MRI contraindications (e.g. subject body habitus incompatible with MRI) Need for advanced heart failure therapy (e.g. IV inotropes) Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial Any other condition that in the judgment of the Investigator would be a contraindication to enrollment or follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shelly L Sayre, MPH
Phone
713-500-9529
Email
Shelly.L.Sayre@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lina Caceres
Phone
305-243-5399
Email
lvc25@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Hare, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fouzia Khan, MBBS
Phone
650-736-1410
Email
fouziak@stanford.edu
First Name & Middle Initial & Last Name & Degree
Ashwini Narayana
Email
ashwinil@stanford.edu
First Name & Middle Initial & Last Name & Degree
Phil Yang, MD
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lina Caceres
Phone
305-243-5399
Email
lvc25@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Jairo Tovar
Phone
305-243-5399
Email
jat243@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Josh Hare, MD
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Wilson
Phone
502-540-3721
Email
heidi.wilson@louisville.edu
First Name & Middle Initial & Last Name & Degree
Julie Caswell
Phone
502-587-4177
Email
julie.caswell@louisville.edu
First Name & Middle Initial & Last Name & Degree
Roberto Bolli, MD
Facility Name
Texas Heart Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nichole Piece
Phone
832-355-9173
Email
npiece@texasheart.org
First Name & Middle Initial & Last Name & Degree
Sylvia Carranza
Phone
832-355-8524
Email
SCarranza@texasheart.org
First Name & Middle Initial & Last Name & Degree
Emerson Perin, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.cctrn.org
Description
Cardiovascular Cell Therapy Research Network
URL
https://www.nih.gov/about-nih/what-we-do/nih-turning-discovery-into-health/stem-cells
Description
Information on stem cells from the National Institutes of Health
URL
http://www.dcmii.org
Description
DCM II Trial

Learn more about this trial

Transendocardial Injection of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy

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