Safety and Efficacy of Adipose Derived Stem Cells for Congestive Heart Failure
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Purpose
The intent of this clinical study is to answer the questions:
- Is the proposed treatment safe
- 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 |
|---|---|---|
|
Ischemic Congestive Heart Failure |
Procedure: Fat Harvesting and Implantation of Adipose Derived Stem Cells |
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 Ischemic Congestive Heart Failure Patients |
- Improvement in 6 Minute Walk Test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Improvement in the 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 ]
- Improvement in the Minnesota Living with Heart Failure Quality of Life Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Improvement in New York Heart Association 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 an echo
- Improvement inn the Left Ventricular Volume [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Improvement in New York Heart Association 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 Volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
-
Procedure: Fat Harvesting and Implantation of Adipose Derived Stem Cells
- Liposuction
- ADSC
- ASC
- Stem Cell therapy
- Catheterization
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Willing and able to sign informed consent
- Age >18 years and < 80 years
- New York Heart Association (NYHA) Class II-IV
- Ischemic cardiomyopathy without an acute coronary syndrome during the prior 6 months
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+)
- Up to date on all age and gender appropriate cancer screening per American Cancer Society
Exclusion Criteria:
- Limiting symptoms due to non-CHF causes, such as lung disease, peripheral vascular disease, arthritis or other musculoskeletal disorders
- Inability to complete a 6-minute walk test for any reason
- Need for intravenous CHF medications, chronic continuous oxygen therapyor oral steroids,
- Coronary Artery Bypass Graft (CABG) surgery within 60 days prior to screening
- Planned revascularization within 4 months following enrollment
- Aortic aneurysm or dilatation (>3.8 cm by echocardiography or other imaging modality)
- Peripheral vascular disease at or below the distal aorta that may interfere with catheter use
- Hemodynamically significant pericardial disease
- Prior aortic or mitral valve replacement
- Biventricular pacing device implant within the last 3 months OR whose device is scheduled to be revised following enrollment in this trial
- Scheduled to receive or history of cardiac transplant, surgical remodeling procedure, left ventricular assist device
- Stroke within 180 days of screening
- Positive pregnancy test in women of child bearing potential or who are unwilling to use an acceptable method of contraception.
- Drug or alcohol dependence
- Life expectancy of less than 1 year
- History of cancer (other than non-melanoma skin cancer or in situ cervical cancer) in the last five years
- 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
- 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| Contact: Janny Garcia, Biomedical Engineer | 855-274-2355 | jgarcia@agelessregen.com |
| Contact: Kristin Comella, Chemical Engineer | kcomella@agelessregen.com |
| Mexico | |
| Instituto de Medicina Regenerativa | Recruiting |
| Tijuana, Baja California, Mexico, 22010 | |
| Contact: Jesus A Perez, MD | |
| Principal Investigator: Juan J Parcero, MD | |
| Principal Investigator: | Juan J Parcero, MD | Instituto de Medicina Regenerativa |
More Information
No publications provided
| Responsible Party: | Ageless Regenerative Institute |
| ClinicalTrials.gov Identifier: | NCT01502514 History of Changes |
| Other Study ID Numbers: | ADI-ME-CHF-002 |
| Study First Received: | December 27, 2011 |
| Last Updated: | December 29, 2011 |
| Health Authority: | Mexico: COFEPRIS- Federal Commission for Protection against Sanitary Risks |
Keywords provided by Ageless Regenerative Institute:
|
CHF ischemia Heart Failure |
Additional relevant MeSH terms:
|
Heart Failure Ischemia Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013