Status:
WITHDRAWN
Safety and Efficacy of Adipose Derived Stem Cells for Non-Ischemic Congestive Heart Failure
Lead Sponsor:
Ageless Regenerative Institute
Collaborating Sponsors:
Instituto de Medicina Regenerativa
Conditions:
Non-Ischemic Congestive Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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...
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 cathet...
Eligibility Criteria
Inclusion
- Willing and able to sign informed consent
- Age \>18 years and \< 80 years
- NYHA Class II-IV
- Congestive Heart Failure without an acute coronary syndrome during the prior 6 months
- 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+)
- Up to date on all age and gender appropriate cancer screening per American Cancer Society
Exclusion
- 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 therapy or oral steroids,
- Coronary Artery Bypass Surgery (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.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01502501
Start Date
May 1 2011
End Date
June 1 2015
Last Update
July 21 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Instituto de Medicina Regenerativa
Tijuana, Estado de Baja California, Mexico, 22010