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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 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.

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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).

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

FieldValue
Enrollment Target 60 participants
Start Date 2024-03-04
Est. Completion 2026-01-01
Phase Phase 2

Sponsor

Roberto Bolli

1 total trials

What the Registry Record Tells You About NCT06145035

The ClinicalTrials.gov registry entry for NCT06145035 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 262-participant average among 14 other Ischemic Heart Disease trials with a reported enrollment target (77% lower). The listed sponsor is Roberto Bolli, which has 1 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.