NCT02503280

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

A Phase I/II, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Transendocardial Injection of Autologous Human Cells (Mesenchymal or the Combination of MSC and Cardiac Stem Cells) in Patients With Chronic Ischemic Left Ventricular Dysfunction and Heart Failure Secondary to Myocardial Infarction.

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Joshua M Hare · Academic / Other
• Sex: All
• Age: 21 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A Phase I/II, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Transendocardial Injection of Autologous Human Cells (Mesenchymal or the combination of MSC and Cardiac Stem Cells) in Patients With Chronic Ischemic Left Ventricular Dysfunction and Heart Failure Secondary to Myocardial Infarction. A total of 55 subjects participating, with 5 in the pilot phase and 50 in the randomized phase. Patients with chronic ischemic left ventricular dysfunction and heart failure secondary to MI scheduled to undergo cardiac catheterization.

Conditions

• Chronic Ischemic Left Ventricular Dysfunction
• Myocardial Infarction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-03-01
• Primary completion: 2030-03-01
• Completion: 2032-03-01
• First posted: 2015-07-20
• Last updated: 2020-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study