Adult Stem Cells
Adult Stem Cells

Adult Stem Cell Clinical Trial for Patients with Non-Ischemic Congestive Heart Failure

CLINICAL TRIAL

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

PURPOSE

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

- Is the proposed treatment safe

- 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?

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  (Clinical Trial Identifier: NCT01502501)

STUDY DESIGN & DATES

Phase I & II, Non-Randomized
Study Start Date: May 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: Dec 2014 (Final data collection date for primary outcome measure)

CONTACTS

Kristin Comella

Phone: 813 390 9874

Email:  This email address is being protected from spambots. You need JavaScript enabled to view it.

LOCATIONS

Mexico: 
Instituto de Medicina Regenerativa
Tijuana, Baja California, Mexico, 22010

INVESTIGATORS

Principal Investigator: Juan J Parcero, MD, Instituto de Medicina Regenerativa

ELIGIBILITY: INCLUSION CRITERIA

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

ELIGIBILITY: EXCLUSION CRITERIA

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

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Adult Stem Cells
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