Adult Stem Cell Clinical Trial for Patients with Type 2 Diabetes
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What? A Phase I/II Clinical Trial to evaluate the safety and efficacy of adipose derived stromal cell (ADSCs) implantation into the pancreatic artery and/or intravenously to help improve the condition of patients with Type 2 Diabetes. 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? Recent studies have focused on adult stem cells that appear to be precursors to islet cells that produce insulin. Over the past several years, studies have utilized pancreatic islet cells to help cure diabetes. Islet cells are cells of the pancreas that secrete insulin and other hormones. These treatments require immunosuppressant therapy to prevent rejection of the cells which can be toxic to the cells and their ability to produce insulin. As a result, these therapies have not been widely utilized due to their limited success.
Several investigators are evaluating the impact of mesenchymal stem cells in subjects with Type 2 Diabetes.
How? Adipose tissue (fat) is obtained by liposuction. Fat-derived mesenchymal stem cells are derived within two hours and delivered back to the patient. Patients will be treated in either of two ways. The first method will involve intra-pancreatic as well as intravenous (IV) administration of the adipose derived stem cells. The second method consists of intravenous (IV) injection only.
June 2011-June 2013
Who may participate? To participate you must meet the following criteria:
- Males and females between 18 and 80 years of age
- Type 2 Diabetes mellitus (as guideline WHO, 1999)
- Weight must fall within guidelines
- Fast blood glucose (FBG)≥7.0 mmol/L, and Hemoglobin A1c≥7％
Who may not participate? You are not eligible to participate if you have any of the following:
- 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
- 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