No need to administer chemotherapy drugs like granulocyte-colony stimulating factor (G-CSF or GCSF) to stimulate the bone marrow to produce granulocytes and stem cells and release them into the bloodstream.
Our mesenchymal stem cells and the US FDA: Are they approved?
No stem cell product from any source, including the patient’s own, is approved by the US FDA to treat autism or any other common condition or disease. From the FDA’s website, “FDA has approved only one stem cell product, Hemacord, a cord blood-derived product manufactured by the New York Blood Center and used for specified indications in patients with disorders affecting the body’s blood-forming system.” (FDA reference)
However, human umbilical cord tissue-derived mesenchymal stem cells (MSCs) that were isolated and grown in our laboratory in Panama to create master cell banks are currently being used in the United States under US FDA regulation.
These cells serve as the starting material for cellular products used in MSC clinical trials for two Duchenne’s muscular dystrophy patients under US FDA’s designation of Investigational New Drug (IND) for single patient compassionate use. (IND 16026 DMD Single Patient).
Will the patient reject this type of stem cell?
The body’s immune system is unable to recognize umbilical cord-derived mesenchymal stem cells as foreign and therefore they are not rejected. HUCT stem cells have been administered thousands of times at the Stem Cell Institute and there has never been a single instance rejection (graft vs. host disease). As a matter of fact, allogeneic (not the patient’s own) mesenchymal stem cells are approved to treat graft vs. host disease in Canada and New Zealand.
Umbilical cord-derived mesenchymal stem cells also proliferate/differentiate more efficiently than “older” cells, such as those found in the fat and therefore, they are considered to be more “potent”.
How are the stem cells administered for autism treatment?
The umbilical cord-derived stem cells are administered intravenously by a licensed physician.
Stem Cell Treatment: Autism *Protocols
Treatment protocol will be assigned by staff physicians after the patient has submitted all requested medical information and received approval. A patient’s recommended protocol may differ from the example given below.
Treatment length (Monday – Friday): 5 Days
Physical examination and blood testing: Monday
4 intravenous infusions of human umbilical cord tissue-derived allogeneic mesenchymal stem cells: Tuesday – Friday
*Includes Hilton hotel room with breakfast, WIFI, transportation from and to the airport with VIP airport gate service and expedited customs clearance upon arrival, and transportation between the Hilton and Stem Cell Institute.
What about follow-up after we return home from Panama?
Proper follow-up is an essential part stem cell therapy for autism. Our primary goal is to ensure that your child is progressing safely. Regular follow-up also enables us to evaluate efficacy and improve our autism treatment protocols based on observed outcomes.
Therefore, our medical staff will be contacting you after 1 month, 3 months, 6 months, and 1 year to monitor your child’s progress.