Adult Stem Cell Clinical Trial for patients with Frailty Syndrome
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What? A Phase I/II Clinical Trial to evaluate the safety and efficacy of intravenous implantation of Adipose-Derived Stem Cells (ADSCs) to help improve the condition of patients with Frailty Syndrome. ADSCs 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? Clinical Trial at Hospital Angeles in Mexico.
Ave. Paseo de los Heroes 10999
Zona Rio, Tijuana Baja California, Mexico Zip Code 22010
Why? This study is being done to determine the effect and safety of adipose-derived stem cells after liposuction. Treatment for frailty syndrome varies depending on cause but usually involves management of the condition with exercise, diet and medication. Recent studies have focused on the use of adult stem cells for osteoporosis and muscle loss indications. Recent studies have identified adipose tissue as a new source of mesenchymal stem cells; some of which may be suitable for the restoration of muscle and bone.
How? Adipose tissue (fat) is obtained after performing liposuction on patients. The cells are derived within two hours and delivered intravenously (via IV) to populate the affected frail regions.
Estimated Primary Completion date: DEC 2014
Estimated Study Completion date: JUNE 2015
Who may participate? To participate you must meet the following criteria:
- Males and Females Age>55.
- Frailty syndrome defined by:
- Low bone mineral density
- Weight guidelines will apply
- Ability to participate in a brief physical performance test
Who may not participate? You are not eligible to participate if you have any of the following:
- Pregnancy, nursing or of childbearing potential and unwilling to maintain contraceptive therapy for the duration of the study
- 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: Ms. Janny Garcia
Ageless Regenerative Institute