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

Conditions

• Non-ischemic Dilated Cardiomyopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• allogeneic human mesenchymal stem cells (hMSCs) — BIOLOGICAL
  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 or a single administration of intravenous allogeneic hMSCs (100 million).
• Placebo — OTHER
  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 or an intravenous placebo infusion of Cell-free PlasmaLyte-A medium supplemented with 1% of 25% human serum albumin (HSA)

Study Details

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

Key Dates

Start date

May 7, 2021

Status verified

Mar 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

136 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Genotype A administered with placebo Group
  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.
• Experimental: Genotype A administered with hMSC Group
  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.
• Placebo Comparator: Genotype B administered with placebo Group
  Participants whose blood genotyping resulted with Genotype B (variants of uncertain significance) and randomized to the placebo group will receive the placebo intervention.
• Experimental: Genotype B administered with hMSC Group
  Participants whose blood genotyping resulted with Genotype B (variants of uncertain significance) and randomized to the treatment group will receive the hMSC intervention.
• Placebo Comparator: Genotype C administered with placebo Group
  Participants whose blood genotyping resulted with Genotype C (pathogenic or likely pathogenic variants) and randomized to the placebo group will receive the placebo intervention.
• Experimental: Genotype C administered with hMSC Group
  Participants whose blood genotyping resulted with Genotype C (pathogenic or likely pathogenic variants) and randomized to the treatment group will receive the hMSC intervention.

Primary Outcome Measure

Change in LVEF [ Time Frame: Baseline, 12 months ]

Central Contacts

• Shelly L Sayre, MPH
  713-500-9529
  [email protected]
• Lina Caceres
  305-243-5399
  [email protected]

Locations (4)

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