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

NCT ID: NCT01502514

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2015-06-30

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 by a series of measurements indicating improvement, stability, or degradation of a patient's cardiovascular function and exercise capacity?

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 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.

Conditions

Ischemic Congestive Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Fat Harvesting and Implantation of Adipose Derived Stem Cells

Local Liposuction will be performed to harvest the fat. The Adipose Derived Stem Cells will be implanted via intramyocardial injection and intravenously.

Intervention Type: PROCEDURE

Other Intervention Names

Liposuction; ADSC; ASC; Stem Cell therapy; Catheterization

Eligibility Criteria

Inclusion Criteria

1. Willing and able to sign informed consent

2. Age >18 years and < 80 years

3. New York Heart Association (NYHA) Class II-IV

4. Ischemic cardiomyopathy without an acute coronary syndrome during the prior 6 months

5. 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+)

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 therapyor oral steroids,

4. Coronary Artery Bypass Graft (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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Medicina Regenerativa

INDUSTRY

Sponsor Role: collaborator

Ageless Regenerative Institute

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan J Parcero, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Medicina Regenerativa

Locations

Instituto de Medicina Regenerativa

Tijuana, Estado de Baja California, Mexico

Countries

Mexico

References

Comella K, Parcero J, Bansal H, Perez J, Lopez J, Agrawal A, Ichim T. Effects of the intramyocardial implantation of stromal vascular fraction in patients with chronic ischemic cardiomyopathy. J Transl Med. 2016 Jun 2;14(1):158. doi: 10.1186/s12967-016-0918-5.

Reference Type: DERIVED

PMID: 27255774 (View on PubMed)

Other Identifiers

ADI-ME-CHF-002

Identifier Type: -

Identifier Source: org_study_id