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

NCT01502514 | Withdrawn Phase 1

• 1 other identifier: ADI-ME-CHF-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The intent of this clinical study is to answer the questions:

1. 1.Is the proposed treatment safe
2. 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?

Conditions

Ischemic Congestive Heart Failure

Keywords

CHF; ischemia; Heart Failure

Outcome Measures

Primary Outcomes (4)

• Improvement in 6 Minute Walk Test

  3 months

• Improvement in the Minnesota Living with Heart Failure Quality of Life Questionnaire

  3 months

• Improvement in 6 Minute Walk Test

  6 months

• Improvement in the Minnesota Living with Heart Failure Quality of Life Questionnaire

  6 months

Secondary Outcomes (6)

• Improvement in New York Heart Association classification

  3 months

• Improvement in the Left Ventricular Ejection Fraction (LVEF)

  3 months

• Improvement inn the Left Ventricular Volume

  3 months

• Improvement in New York Heart Association classification

  6 months

• Improvement in the Left Ventricular Ejection Fraction (LVEF)

  6 months

Interventions

Fat Harvesting and Implantation of Adipose Derived Stem Cells PROCEDURE

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

Also known as: Liposuction, ADSC, ASC, Stem Cell therapy, Catheterization

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ageless Regenerative Institute: lead
• Instituto de Medicina Regenerativa: collaborator

Study Sites (1)

Instituto de Medicina Regenerativa

Tijuana, Estado de Baja California, 22010, Mexico

Location

Related Publications (1)

• 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.

  PMID: 27255774 DERIVED

MeSH Terms

Conditions

Ischemia; Heart Failure

Interventions

Lipectomy; Catheterization

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures; Investigative Techniques

Study Officials

• Juan J Parcero, MD

  Instituto de Medicina Regenerativa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2011
• First Posted: December 30, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

ME (1)