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

NCT01502501 | Withdrawn

• 1 other identifier: ADI-ME-CHF-001
• 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

Non-Ischemic Congestive Heart Failure

Keywords

CHF; Heart Failure; Non-Ischemic; nonischemic; nonischemia

Outcome Measures

Primary Outcomes (5)

• Improvement in 6 minute walk test

  compared to baseline

  3 months

• Minnesota Living with Heart Failure Quality of Life Questionnaire

  3 months

• Improvement in 6 minute walk test

  6 months

• Minnesota Living with Heart Failure Quality of Life Questionnaire

  6 months

• Number of Adverse Events

  6 months

Secondary Outcomes (6)

• Improvement in New York Heart Association (NYHA) classification

  3 months

• Improvement in the Left Ventricular Ejection Fraction (LVEF)

  3 months

• Improvement in the Left Ventricular (LV) Volume

  3 months

• Improvement in New York Heart Association (NYHA) classification

  6 months

• Improvement in the Left Ventricular Ejection Fraction (LVEF)

  6 months

Interventions

Harvesting and Implantation of Adipose-Derived Stem Cells (ASCs) PROCEDURE

Local liposuction procedure to harvest the fat tissue. Adipose Derived Stem Cells are then implanted via intramyocardial and intravenous injection.

Also known as: Lipo, Liposuction, Catheter, IV, ADSC

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
• 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

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 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

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

MeSH Terms

Conditions

Heart Failure

Interventions

HMGA2 Protein; Lipectomy; Catheters

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

HMGA Proteins; DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins; High Mobility Group Proteins; Chromosomal Proteins, Non-Histone; Nuclear Proteins; Nucleoproteins; Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures; Equipment and Supplies

Study Officials

• Juan J Parcero, MD

  Instituto de Medicina Regenerativa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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)