RECRUITING

Administration of Allogeneic-MSC in Patients with Non-Ischemic Dilated Cardiomyopathy

Conditions

Non-ischemic Dilated Cardiomyopathy Allogeneic mesenchymal stem cells Bone marrow-derived mesenchymal stem cells

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase IIB Randomized, Placebo-Controlled, Multicenter Study of the Comparative Efficacy and Safety of Administration of Allogeneic-MSC Versus Placebo in Patients with Non- Ischemic Dilated Cardiomyopathy

Quick Facts

Study Start:2021-05-07

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04476901

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Shelly L Sayre, MPH

CONTACT

713-500-9529

Shelly.L.Sayre@uth.tmc.edu

Lina Caceres

CONTACT

305-243-5399

lvc25@med.miami.edu

Principal Investigator

Joshua Hare, MD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

Stanford University

Stanford, California, 94304

United States

University of Miami Miller School of Medicine

Miami, Florida, 33136

United States

University of Louisville

Louisville, Kentucky, 40202

United States

Texas Heart Institute

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Joshua M Hare

Joshua Hare, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-07

Study Completion Date2025-12

Study Record Updates

Study Start Date2021-05-07

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Allogeneic mesenchymal stem cells
Bone marrow-derived mesenchymal stem cells

Additional Relevant MeSH Terms

Non-ischemic Dilated Cardiomyopathy