Adult Stem Cell Clinical Trial for Patients with Non-Ischemic Congestive Heart Failure
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What? A Phase I/II Clinical Trial to evaluate the safety and efficacy of intramyocardial and intravenous implantation of adipose-derived stem cells (ADSC's) to help improve the condition of patients with Non-Ischemic Congestive Heart Failure. Adipose-derived stem cells are obtained from the patient's fat.
The study is an open-label, non-randomized study. Open-label means that the patient and doctor will know the treatment patient is getting in the study. The study is underwritten by the patient. The patient will cover all costs associated with the therapy and treatment.
Where? Hospital Angeles in Mexico
Ave. Paseo de los Heroes 10999
Zona Rio, Tijuana Baja California, Mexico Zip Code 22010
Why? The dilated form of cardiomyopathy is involved in one in three cases of congestive heart failure. This condition is associated with a significant reduction in the pumping ability of the heart due to enlarged or dilated chambers. Currently, no cure exists for this form of cardiomyopathy, and patients face a 50 percent survival rate after five years of being diagnosed with heart failure. Studies have shown that mesenchymal stem cells may induce myogenesis and angiogenesis and inhibit myocardial fibrosis. These properties make mesenchymal stem cells a promising therapy for patients suffering from Non-Ischemic Congestive Heart Failure.
How? Adipose tissue (fat) is obtained by liposuction under local anesthesia. The adipose-derived mesenchymal stem cells are derived within two hours and delivered via intramyocardial and intravenous routes.
When? Ongoing (Estimated primary completion date DEC 2014; estimated final completion date JUNE 2015)
Who may participate?To participate you must meet the following criteria:
- Between18 and 80 years old
- Can easily walk less than two blocks
- Congestive Heart Failure without an acute coronary syndrome during the prior six months
- Left ventricular ejection fraction (LVEF) less than or equal to 40 percent 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 valve disease
Who may not participate? You are not eligible to participate if you have any of the following:
- Inability to complete a six minute walk test for any reason
- Coronary Artery Bypass Graft (CABG) surgery within 60 days prior to screening
- Planned revascularization within four months following enrollment
- Aortic aneurysm or dilatation
- Prior aortic or mitral valve replacement
- Biventricular pacing device implant within the last three 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
- Active infectious disease
- Patients on chronic immunosuppressive transplant therapy
- Known drug or alcohol dependence or any other factors which will interfere with the study conduct
- Severe asthma that would contraindicate surgery
- History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
- Inclusion in any other clinical study that may affect the outcome of this study
- A study physician will go over additional exclusion criteria with you.
For more information:
For more information regarding the clinical trial and the inclusion/exclusion please contact:
Ageless Regenerative Institute