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Mesenchymal Stem Cell Therapy

Stem Cell Therapy for Dilated Cardiomyopathy (DCMII Trial)

Phase 2

Recruiting

Led By Joshua Hare, MD

Research Sponsored by Joshua M Hare

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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%.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Summary

This trial is testing whether a new stem cell therapy is safe and works for people with a certain disease.

Who is the study for?

This trial is for adults aged 18-80 with non-ischemic dilated cardiomyopathy (NIDCM) and a left ventricular ejection fraction ≤45%. Participants must be on stable heart medication for at least 30 days. Exclusions include drug/alcohol abuse, certain types of cardiomyopathy, recent organ/cell transplant rejection, coronary artery disease history, known LV thrombus or aneurysm, severe allergies to specific antibiotics or DMSO.

What is being tested?

The study tests the safety and effectiveness of allogeneic human mesenchymal stem cells (hMSCs) versus placebo in treating NIDCM. Patients will receive either hMSCs or placebo through transendocardial injection during cardiac catheterization.

What are the potential side effects?

Potential side effects may include reactions related to stem cell therapy such as immune response complications, infection risk increase due to immunosuppression from the procedure, allergic reactions to components like penicillin or streptomycin used within the treatment preparation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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My heart pumps less blood than normal.

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I am on a stable heart medication regimen for non-ischemic cardiomyopathy.

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I am eligible for a heart catheterization procedure.

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I am willing to have a DNA test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in LVEF

Secondary study objectives

Change in EPC-CFU

Change in Exercise tolerance

Change in LVEDVI

+12 more

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Genotype C administered with hMSC GroupExperimental Treatment1 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.

Group II: Genotype B administered with hMSC GroupExperimental Treatment1 Intervention

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

Group III: Genotype A administered with hMSC GroupExperimental Treatment1 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.

Group IV: Genotype A administered with placebo GroupPlacebo Group1 Intervention

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.

Group V: Genotype C administered with placebo GroupPlacebo Group1 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.

Group VI: Genotype B administered with placebo GroupPlacebo Group1 Intervention

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

0 / 5Eligibility criteria met