NCT01502501

Safety and Efficacy of Adipose Derived Stem Cells for Non-Ischemic Congestive Heart Failure

An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Cardiovascular Effects of Intramyocardial and Intravenous Implantation of Autologous Adipose-Derived Stem Cells in Non-Ischemic Congestive Heart Failure Patients

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ageless Regenerative Institute · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The intent of this clinical study is to answer the questions: 1. Is the proposed treatment safe 2. Is treatment effective in improving the disease pathology of patients with Heart Disease as assessed by a series of measurements indicating improvement, stability, or degradation of a patient's cardiovascular function and exercise capacity?

Detailed description

This will be an open-label, non-randomized, multi-center patient-sponsored study designed to assess the safety and cardiovascular effects of Adipose-derived Stem Cell (ASC) implantation using a catheter delivery system in patients who have nonischemic congestive heart failure. A percutaneous transluminal endomyocardial injection catheter will be used for delivery of ASCs. The therapy is composed of cells isolated from a patient's own adipose tissue. Liposuction will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.

Conditions

• Non-Ischemic Congestive Heart Failure

Interventions

Type	Name	Description
PROCEDURE	Harvesting and Implantation of Adipose-Derived Stem Cells (ASCs)	Local liposuction procedure to harvest the fat tissue. Adipose Derived Stem Cells are then implanted via intramyocardial and intravenous injection.

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-12-01
• Completion: 2015-06-01
• First posted: 2011-12-30
• Last updated: 2017-07-21

Locations

1 site across 1 country: Mexico