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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Ageless Regenerative Institute
Sponsor:
Collaborator:
Instituto de Medicina Regenerativa, S.A. de C.V.
Information provided by (Responsible Party):
Ageless Regenerative Institute
ClinicalTrials.gov Identifier:
NCT01502501
First received: December 27, 2011
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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 Phase
Non-Ischemic Congestive Heart Failure
Procedure: Harvesting and Implantation of Adipose-Derived Stem Cells (ASCs)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]
    compared to baseline

  • Minnesota Living with Heart Failure Quality of Life Questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement in 6 minute walk test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Minnesota Living with Heart Failure Quality of Life Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in New York Heart Association (NYHA) classification [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement in the Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Determined by and echo

  • Improvement in the Left Ventricular (LV) Volume [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Determined by an echo

  • Improvement in New York Heart Association (NYHA) classification [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Improvement in the Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Improvement in the Left Ventricular (LV) Volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01502501

Contacts
Contact: Kristin Comella 813390 9874 kcomella@agelessregen.com

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

No publications provided

Responsible Party: Ageless Regenerative Institute
ClinicalTrials.gov Identifier: NCT01502501     History of Changes
Other Study ID Numbers: ADI-ME-CHF-001
Study First Received: December 27, 2011
Last Updated: October 28, 2013
Health Authority: Mexico: COFEPRIS- Federal Commission for Protection against Sanitary Risks

Keywords provided by Ageless Regenerative Institute:
CHF
Heart Failure
Non-Ischemic
nonischemic
nonischemia

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014