Non-Ischemic Congestive Heart Failure Clinical Trial
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
| Verified date | July 2017 |
| Source | Ageless Regenerative Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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?
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 2015 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Mexico | Instituto de Medicina Regenerativa | Tijuana | Baja California |
| Lead Sponsor | Collaborator |
|---|---|
| Ageless Regenerative Institute | Instituto de Medicina Regenerativa, S.A. de C.V. |
Mexico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Improvement in 6 minute walk test | compared to baseline | 3 months | |
| Primary | Minnesota Living with Heart Failure Quality of Life Questionnaire | 3 months | ||
| Primary | Improvement in 6 minute walk test | 6 months | ||
| Primary | Minnesota Living with Heart Failure Quality of Life Questionnaire | 6 months | ||
| Primary | Number of Adverse Events | 6 months | ||
| Secondary | Improvement in New York Heart Association (NYHA) classification | 3 months | ||
| Secondary | Improvement in the Left Ventricular Ejection Fraction (LVEF) | Determined by and echo | 3 months | |
| Secondary | Improvement in the Left Ventricular (LV) Volume | Determined by an echo | 3 months | |
| Secondary | Improvement in New York Heart Association (NYHA) classification | 6 months | ||
| Secondary | Improvement in the Left Ventricular Ejection Fraction (LVEF) | 6 months | ||
| Secondary | Improvement in the Left Ventricular (LV) Volume | 6 months |