Study Summary
This trial is testing whether a new stem cell therapy is safe and works for people with a certain disease.
Eligible Conditions
- Nonischemic Dilated Cardiomyopathy
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 15 Secondary · Reporting Duration: 12 months
12 months
Incidence of MACE
Left ventricular function concordance
Baseline, 12 months
Change in EPC-CFU
Change in Exercise tolerance
Change in LVEDVI
Change in LVEF
Change in LVESVI
Change in Maximal oxygen consumption (peak VO2)
Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Score
Change in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
Change in New York Heart Association (NYHA) Class
Change in cytokines
Change in global ventricular strain
Change in left regional strain
Percent change in flow mediated diameter
Day 30
Incidence of TE-SAEs
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
6 Treatment Groups
Genotype C administered with hMSC Group
1 of 6
Genotype B administered with hMSC Group
1 of 6
Genotype A administered with hMSC Group
1 of 6
Genotype B administered with placebo Group
1 of 6
Genotype A administered with placebo Group
1 of 6
Genotype C administered with placebo Group
1 of 6
Experimental Treatment
Non-Treatment Group
136 Total Participants · 6 Treatment Groups
Primary Treatment: allogeneic human mesenchymal stem cells (hMSCs) · Has Placebo Group · Phase 2
Genotype C administered with hMSC Group
Biological
Experimental Group · 1 Intervention: allogeneic human mesenchymal stem cells (hMSCs) · Intervention Types: BiologicalGenotype B administered with hMSC Group
Biological
Experimental Group · 1 Intervention: allogeneic human mesenchymal stem cells (hMSCs) · Intervention Types: BiologicalGenotype A administered with hMSC Group
Biological
Experimental Group · 1 Intervention: allogeneic human mesenchymal stem cells (hMSCs) · Intervention Types: BiologicalGenotype B administered with placebo Group
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherGenotype A administered with placebo Group
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherGenotype C administered with placebo Group
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Who is running the clinical trial?
United States Department of DefenseFED
779 Previous Clinical Trials
202,424 Total Patients Enrolled
Joshua M HareLead Sponsor
15 Previous Clinical Trials
374 Total Patients Enrolled
1 Trials studying Nonischemic Dilated Cardiomyopathy
37 Patients Enrolled for Nonischemic Dilated Cardiomyopathy
The University of Texas Health Science Center, HoustonOTHER
811 Previous Clinical Trials
256,121 Total Patients Enrolled
Joshua Hare, MDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
400 Total Patients Enrolled
Eligibility Criteria
Age 18 - 80 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are willing to undergo DNA test.\n
You have a diagnosis of NIDCM with a left ventricular ejection fraction of ≤45%.
Subjects must be on beta blockers and ACE inhibitors or ARBs or ARNI or have appropriate medical indication precluding use of one or both of these agents
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Conditions
Cancer Related
Treatments