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NCT06145035 · ClinicalTrials.gov registry record · Phase 2
Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy
A Phase 2 study of Ischemic Heart Disease, sponsored by Roberto Bolli.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 3
- Study locations
NCT06145035: Recruiting Phase 2 study of Ischemic Heart Disease, sponsored by Roberto Bolli.
NCT06145035 is a Phase 2 study of Ischemic Heart Disease that is actively recruiting participants, run by Roberto Bolli. The registered enrollment target is 60 participants, below the 262-participant average among 14 other Ischemic Heart Disease trials with a reported enrollment target (77% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06145035, a Phase 2 study of Ischemic Heart Disease, is actively recruiting participants, sponsored by Roberto Bolli.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 3
- Study locations
Study Summary
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), administered intravenously (IV) as a single dose or repeated doses, in patients with ischemic cardiomyopathy (ICM).
Primary Outcome
Change in left ventricular ejection fraction as assessed via cardiac MRI. Units: %
Conditions Studied
Interventions
- BIOLOGICAL umbilical cord-derived mesenchymal stromal cells (UC-MSCs)
Study Locations (3)
Florida
- University of Miami Miller School of Medicine - Miami
Kentucky
- University of Louisville School of Medicine, Institute of Molecular Cardiology - Louisville
Texas
- The Texas Heart Institute Houston Texas - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-03-04 |
| Est. Completion | 2026-01-01 |
| Phase | Phase 2 |
What NCT06145035 shows while recruiting
NCT06145035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 262-participant average among 14 other Ischemic Heart Disease trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Ischemic Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which umbilical cord-derived mesenchymal stromal cells (UC-MSCs) is the first listed.
NCT06145035 reports a single indexed study location in Florida, Kentucky, Texas.
Frequently Asked Questions
What is clinical trial NCT06145035 about?
NCT06145035 is a clinical study titled "Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy". 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), administered intravenously (IV) as a single dose or repeated doses, in patients with ischemic c...
What is the current status of trial NCT06145035?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2024-03-04. Estimated completion is 2026-01-01.
What conditions does trial NCT06145035 study?
This clinical trial studies the following conditions: Ischemic Heart Disease.
What interventions are being tested in trial NCT06145035?
The interventions under investigation include: umbilical cord-derived mesenchymal stromal cells (UC-MSCs) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06145035?
This trial is sponsored by Roberto Bolli, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06145035 being conducted?
This trial has 3 study locations across Florida, Kentucky, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ischemic Heart Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06145035's enrollment target sits among peer trials
60 10th of 14 higher than 5 of 14 other Ischemic Heart Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ischemic Heart Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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