Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy

Part of paid clinical trials in Miami, Florida.

Sponsor
Roberto Bolli
Study ID
NCT06145035
Phase
PHASE2
Status
Recruiting
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Conditions

  • Ischemic Heart Disease

Eligibility Criteria

Sex
ALL
Age
21 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • umbilical cord-derived mesenchymal stromal cells (UC-MSCs) — BIOLOGICAL
    The study product will consist of 100 million UC-MSCs suspended in a final volume of 60 ml given at a rate of 3.3 million cells/min. The product will be infused into vein via intravenous line placed in the arm.

Study Details

This is a Phase IIA, randomized, double blind, placebo controlled, multicenter study designed to assess the safety, feasibility, and efficacy of umbilical cord derived mesenchymal stromal cells (UC MSCs, stem cells), administered intravenously (IV) as a single dose or repeated doses, in patients with ischemic cardiomyopathy (ICM).

Key Dates

Start date
Mar 4, 2024
Status verified
May 2026
Primary completion
Jan 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: control group
    Four doses of vehicle (Plasma-Lyte A supplemented with 1% HSA) will be given 2 months apart. Each dose will be infused IV at a rate of 2 ml/min for a total of 60 ml over 30 minutes.
  • Experimental: single-dose group
    One dose of UC-MSCs (100 x 106 cells) will be infused IV at a rate of 2 ml/min for a total of 60 ml over 30 minutes (3.3 million cells/ml/min). This will be followed by three IV infusions of placebo (same volume and rate) 2, 4, and 6 months later.
  • Experimental: repeated-dose group
    Four doses of UC-MSCs (100 x 106 cells each) will be given 2 months apart. Each dose will be infused IV at a rate of 2 ml/min for a total of 60 ml over 30 minutes (3.3 million cells/ml/min).

Primary Outcome Measure

change in LVEF (D LVEF) between baseline (M0) and 12 months after the first study product infusion (SPI) (M12) [ Time Frame: Baseline, 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Miami Miller School of MedicineMiamiFlorida33136
Joshua Hare, MD
[email protected]
305-243-1152
Ana Garzon
[email protected]
305-243-1152
University of Louisville School of Medicine, Institute of Molecular CardiologyLouisvilleKentucky40202
Roberto Bolli, MD
[email protected]
502-608-5426
Michelle Unseld, RN
[email protected]
502-540-3423
Roberto Bolli, MD (PRINCIPAL_INVESTIGATOR)
The Texas Heart Institute Houston TexasHoustonTexas77030
Emerson Perin, MD
[email protected]
832-355-9173
Nicole Piece
[email protected]
832-355-9173

Find similar trials in Miami, FL

By research site
University of Miami Miller School of Medicine· Miami, FLUniversity of Louisville School of Medicine, Institute of Molecular Cardiology· Louisville, KYThe Texas Heart Institute Houston Texas· Houston, TX

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