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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
Awards & highlights

DCMII Trial 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.Check my eligibility
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.See study design
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.

DCMII Trial 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.

DCMII Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in LVEF
Secondary outcome measures
Change in EPC-CFU
Change in Exercise tolerance
Change in LVEDVI
+12 more

DCMII 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.

Find a Location

Who is running the clinical trial?

Joshua M HareLead Sponsor
15 Previous Clinical Trials
273 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
227,058 Total Patients Enrolled
The University of Texas Health Science Center, HoustonOTHER
903 Previous Clinical Trials
320,841 Total Patients Enrolled

Media Library

Allogeneic Human Mesenchymal Stem Cells (hMSCs) (Mesenchymal Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04476901 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA have any official stance on allogeneic human mesenchymal stem cells?

"While Phase 2 trials offer less evidence than later stages of testing, the available data suggests that allogeneic human mesenchymal stem cells are safe."

Answered by AI

What are the participant qualifications for this trial?

"Yes, the latest information on clinicaltrials.gov suggests that this trial is still looking for participants. The posting date was May 7th 2021 and the most recent update was on October 24th, 2020. They are hoping to enrol 136 patients from 4 different locations."

Answered by AI

Could you please tell me if this trial is available to people who are under 30 years old?

"According to the guidelines for this experiment, the minimum age an individual can be is 18 and the maximum age is 80."

Answered by AI

At how many different sites is this trial being conducted?

"The six sites for this clinical trial are the University of Miami Miller School of Medicine in Miami, Florida; Stanford University in Stanford, California; the University of Louisville in Louisville, Kentucky; and four additional locations."

Answered by AI

If I join this experiment, will my insurance cover the treatments?

"The ideal candidate for this study would have a diagnosis of cardiomyopathy, be of dilated variety, and between 18-80 years old. A total of 136 individuals are needed to complete the clinical trial."

Answered by AI

Does this research project need more test subjects at this time?

"That is correct. The clinical trial in question, which began recruiting on May 7th, 2021, is still looking for participants. According to the latest update on October 24th, 2022, they require 136 more people at 4 different locations."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Kentucky
What site did they apply to?
University of Louisville
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1

What questions have other patients asked about this trial?

How often are seen by a doctor during this trial?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I do not have any heart problems; never had. I am interested in trying other medicines for my condition.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Transendocardial Injection of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy
Joshua M Hare 2021. "Transendocardial Injection of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04476901.
All > Anterior Ischemic Optic Neuropathy
~23 spots leftby Dec 2024
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