Are the Treatments FDA Approved?
Bioscience Americas ...Solutions for a Healthier World.
Are the GIOSTAR/ Bioscience High Performance procedures performed in the U.S. approved by the FDA?
The complete answer is not clear cut unfortunately. The short answer is both, Yes and No
All of the procedures performed throughout our U.S. GIOSTAR/Bioscience High Performance Procedure Network are same-day procedures. This means that the patient’s cells are harvested in the morning, isolated and processed, then re-injected into the patient’s injured area – all within a period of a few hours.
All of the GIOSTAR/ Bioscience High Performance Stem Cell and Blood Platelet Procedures performed in the U.S. today are same-day procedures that are compliant with CFR 21 Part 1271, falling under the same surgery exemption discussed in 1271.15 (b).
IT’S IMPORTANT TO NOTE:
The FDA does not “approve” or “not approve” medical procedures (like a kidney surgery for example). This is considered a medical procedure. We are in compliance with all procedure codes; the FDA does not have any issues with the protocols and procedures we offer in the U.S.
The GIOSTAR / Bioscience Americas Stem Cell Protocols for the treatment of auto immune disease are not always approved by the FDA nor are they governed by the FDA. However, we go to great lengths working with the government to stay in compliance wherever our clinics are found.
There are two aspects to consider regarding the use of stem cell therapies in the U.S. and potential host countries outside of the U.S.
The first is the existing legal structure surrounding research and secondly, the regulatory framework regarding application of that research to treat patients.
The Global Institute of Stem Cell Therapy and Research (GIOSTAR) adheres to the guidelines promulgated by the U.S. Food and Drug Administration (FDA) under the U.S. Department of Health and Human Services, Code of Federal Regulation, Part 1271 entitled “Regulation of Human Cells, Tissues and, Cellular and Tissue Based Products”. CFR 21 Part 1271
The FDA makes a clear distinction of minimally manipulated cells and autologous transplantation from other cell types when it states in Part 1271, that ‘you are not required to comply with the requirements of this part if you are an establishment that removes human cells, tissues and, cellular and tissue-based products from an individual and implants such products into the same individual during the same surgical procedure’. What this implies is that minimally manipulated and autologous cell therapy should not have regulations which are in place for other human cells, tissues and, tissue based products and drugs.
GIOSTAR follows Part 1271 CFR 21 Part 1271for adult autologous stem cell transplant.
Adult HSC (Hematopoietic Stem Cell) transplants under practice and approved by US FDA over the last 30 years include the following examples of diseases:
- Acute myeloid leukemia (AML)
- Chronic myeloid leukemia (CML)
- Acute lymphoblastic leukemia (ALL)
- Hodgkin lymphoma (relapsed, refractory)
- Non-Hodgkin (relapsed or refractory) lymphoma
- Ewing sarcoma
- Multiple Myeloma
- Myelodysplastic syndromes
- Gliomas, other solid tumors
- Sickle Cell Anemia
- Aplastic anemia
- Fanconi anemia
- Immune deficiency syndromes
- Inborn errors of metabolism
Regarding patient application in our host countries, prohibitions are generally in place regulating the use of embryonic stem cell. GIOSTAR does NOT conduct research or treat patients with embryonic stem cells.
As currently applied in Colombia, for example, patient therapies will be administered under FDA Part 1271 guidelines, as noted above, operating under the authority and license of the attending physician and associated medical professionals.