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

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?

Study Overview

• Status: Withdrawn
• Conditions: Non-Ischemic Congestive Heart Failure
• Intervention / Treatment: Procedure: Harvesting and Implantation of Adipose-Derived Stem Cells (ASCs)

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Baja California
    • Tijuana, Baja California, Mexico, 22010
      • Instituto de Medicina Regenerativa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Willing and able to sign informed consent
2. Age >18 years and < 80 years
3. NYHA Class II-IV
4. Congestive Heart Failure without an acute coronary syndrome during the prior 6 months

5. LVEF less than or equal to 40% measured by echocardiography at both local and investigative sites, AND

   • 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 therapy or oral steroids,
4. Coronary Artery Bypass Surgery (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
11. Scheduled to receive or history of cardiac transplant, surgical remodeling procedure, left ventricular assist device
12. Stroke within 180 days of screening
13. Positive pregnancy test in women of child bearing potential or who are unwilling to use an acceptable method of contraception.
14. Drug or alcohol dependence
15. Life expectancy of less than 1 year
16. History of cancer (other than non-melanoma skin cancer or in situ cervical cancer) in the last five years
17. Exposure to angiogenic therapy (including myocardial laser) or another investigational drug within 60 days of screening, or enrollment in any concurrent study that may confound the results of this study
18. Any factors in the opinion of the Investigator which render the patient unsuitable for participation, that will interfere with conduct of the study or interpretation of the results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in 6 minute walk test	compared to baseline	3 months
Minnesota Living with Heart Failure Quality of Life Questionnaire		3 months
Improvement in 6 minute walk test		6 months
Minnesota Living with Heart Failure Quality of Life Questionnaire		6 months
Number of Adverse Events		6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in New York Heart Association (NYHA) classification		3 months
Improvement in the Left Ventricular Ejection Fraction (LVEF)	Determined by and echo	3 months
Improvement in the Left Ventricular (LV) Volume	Determined by an echo	3 months
Improvement in New York Heart Association (NYHA) classification		6 months
Improvement in the Left Ventricular Ejection Fraction (LVEF)		6 months
Improvement in the Left Ventricular (LV) Volume		6 months

Collaborators and Investigators

• Sponsor: Ageless Regenerative Institute
• Collaborators: Instituto de Medicina Regenerativa
• Investigators: Principal Investigator: Juan J Parcero, MD, Instituto de Medicina Regenerativa

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: December 27, 2011
• First Submitted That Met QC Criteria: December 29, 2011
• First Posted (Estimate): December 30, 2011

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Heart Failure; CHF; Non-Ischemic; nonischemic; nonischemia
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: ADI-ME-CHF-001