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

This study has been withdrawn prior to enrollment.
Instituto de Medicina Regenerativa, S.A. de C.V.
Information provided by (Responsible Party):
Ageless Regenerative Institute Identifier:
First received: December 27, 2011
Last updated: March 20, 2017
Last verified: March 2017

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?

Condition Intervention
Non-Ischemic Congestive Heart Failure
Procedure: Harvesting and Implantation of Adipose-Derived Stem Cells (ASCs)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Ageless Regenerative Institute:

Primary Outcome Measures:
  • Improvement in 6 minute walk test [ Time Frame: 3 months ]
    compared to baseline

  • Minnesota Living with Heart Failure Quality of Life Questionnaire [ Time Frame: 3 months ]
  • Improvement in 6 minute walk test [ Time Frame: 6 months ]
  • Minnesota Living with Heart Failure Quality of Life Questionnaire [ Time Frame: 6 months ]
  • Number of Adverse Events [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Improvement in New York Heart Association (NYHA) classification [ Time Frame: 3 months ]
  • Improvement in the Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 3 months ]
    Determined by and echo

  • Improvement in the Left Ventricular (LV) Volume [ Time Frame: 3 months ]
    Determined by an echo

  • Improvement in New York Heart Association (NYHA) classification [ Time Frame: 6 months ]
  • Improvement in the Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 6 months ]
  • Improvement in the Left Ventricular (LV) Volume [ Time Frame: 6 months ]

Enrollment: 0
Study Start Date: May 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Names:
    • Lipo
    • Liposuction
    • Catheter
    • IV
    • ADSC
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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01502501

Instituto de Medicina Regenerativa
Tijuana, Baja California, Mexico, 22010
Sponsors and Collaborators
Ageless Regenerative Institute
Instituto de Medicina Regenerativa, S.A. de C.V.
Principal Investigator: Juan J Parcero, MD Instituto de Medicina Regenerativa
  More Information

Responsible Party: Ageless Regenerative Institute Identifier: NCT01502501     History of Changes
Other Study ID Numbers: ADI-ME-CHF-001
Study First Received: December 27, 2011
Last Updated: March 20, 2017

Keywords provided by Ageless Regenerative Institute:
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on April 27, 2017