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

NCT01502514•Ageless Regenerative Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Willing and able to sign informed consent
•2. Age \>18 years and \< 80 years
•3. New York Heart Association (NYHA) Class II-IV
•4. Ischemic cardiomyopathy without an acute coronary syndrome during the prior 6 months
•5. Left Ventricular Ejection Fraction (LVEF) less than or equal to 40% measured by echocardiography at both local and investigative sites, AND:
•* Well-demarcated region of LV systolic dysfunction.
•* Left ventricular wall without mural thrombus and of thickness greater than 0.5 cm
•* No significant valvular disease including: Moderate-to-severe mitral regurgitation (3-4+), aorticstenosis (valve area \<1.5 cm2), aortic insufficiency (3-4+)
•6. Up to date on all age and gender appropriate cancer screening per American Cancer Society

Exclusion Criteria

•1. Limiting symptoms due to non-CHF causes, such as lung disease, peripheral vascular disease, arthritis or other musculoskeletal disorders
•2. Inability to complete a 6-minute walk test for any reason
•3. Need for intravenous CHF medications, chronic continuous oxygen therapyor oral steroids,
•4. Coronary Artery Bypass Graft (CABG) surgery within 60 days prior to screening
•5. Planned revascularization within 4 months following enrollment
•6. Aortic aneurysm or dilatation (\>3.8 cm by echocardiography or other imaging modality)
•7. Peripheral vascular disease at or below the distal aorta that may interfere with catheter use
•8. Hemodynamically significant pericardial disease
•9. Prior aortic or mitral valve replacement
•10. Biventricular pacing device implant within the last 3 months OR whose device is scheduled to be revised following enrollment in this trial
+8 more criteria

Locations (1)

Instituto de Medicina Regenerativa

Tijuana, Estado de Baja California, Mexico

Key Dates

Start Date

May 1, 2011

Primary Completion Date

December 1, 2014

Completion Date

June 1, 2015

Last Updated

July 21, 2017

Conditions

Ischemic Congestive Heart Failure

Interventions

Fat Harvesting and Implantation of Adipose Derived Stem Cells

PROCEDURE