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The Transendocardial Autologous Cells (hMSC) or (hMSC) and (hCSC) in Ischemic Heart Failure Trial.

NCT02503280 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2020-10-22

No results posted yet for this study

Summary

Before initiating the full randomized study, a Pilot Safety Phase will be performed. In this phase the composition of cells administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested. The randomized portion of the study will be conducted after a full review of the safety data from the pilot Phase by the Data safety monitoring board.

Following the Pilot Phase of five (5) Fifty (50) patients scheduled to undergo cardiac catheterization and meeting all inclusion/exclusion criteria will be evaluated at baseline.

Patients will be randomized in a 2:2:1 ratio to one of three Treatment Strategies.

Conditions

Interventions

DRUG

Autologous hMSCs

Autologous hMSCs: 40 million cells/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 2 x 10\^8 (200 million) hMSCs.

DRUG

Autologous Human C-Kit CSCs II

Autologous hMSCs PLUS autologous C-Kit hCSCs: Mixture of 39.8 million hMSCs and 0.2 million C-Kit hCSCs/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 1.99 x 10\^8 (199 million) hMSCs and 1 million C-Kit hCSCs.

DRUG

Placebo

Placebo (ten 0.5 ml injections of phosphate-buffered saline \[PBS\] and 1% human serum albumin \[HSA\]).

DEVICE

Biosense Webster MyoStar NOGA Injection Catheter System

Biosense Webster MyoStar NOGA Injection Catheter System will be used to administer the study drug

Sponsors & Collaborators

  • Joshua M Hare

    lead OTHER

Principal Investigators

  • Joshua M Hare, MD · ISCI / University of Miami Miller School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2030-03-31
Completion
2032-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02503280 on ClinicalTrials.gov