NCT01502514

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

• Status: Withdrawn
• Phase: Phase 1
• 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 experienced myocardial infarction. 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

• Ischemic Congestive Heart Failure

Interventions

Type	Name	Description
PROCEDURE	Fat Harvesting and Implantation of Adipose Derived Stem Cells	Local Liposuction will be performed to harvest the fat. The Adipose Derived Stem Cells will be implanted via intramyocardial injection and intravenously.

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