Question for Neil Riordan PhD: Do you use all types of these stem cell applications—stromal vascular fraction and autologous and umbilical? If so, how do you decide which to use for a person? Dr. Riordans Answer: Our doctors have used the patient’s own stromal vascular fraction (SVF) for several years for autoimmune and orthopedic conditions. To my knowledge we were to first to use SVF in humans. Dr. Bob Harman, the CEO of Vet-Stem has been using SVF in animals in the U.S. for years. It is a bit ironic that your dog, cat, or even horse can get this treatment in the U.S. but FDA is taking the position that your own cells are a new drug because an enzyme (found in nature) is used to isolate the cells, and you put the cells back in a different place than you found them (non-homologous use). Bob and I have had many conversations over the years. The first use of SVF in humans was a lady from the U.S.—the wife of a doctor who refers patients to us. She suffered from rheumatoid arthritis. She had a very good response to treatment. Prior to them coming to the clinic Bob had told me about a dog that had a disease similar to rheumatoid arthritis and had responded very well to intravenous SVF. I put the doctor on the phone with Bob and after our Ethical Review Committee approved the protocol, she was treated. Subsequently we started treating MS patients with a combination of SVF and umbilical cord cells. The two main points of rationale were that you could obtain such large numbers of MSCs from a single liposuction at a relatively low cost (at the time cultured MSCs were much more expensive to isolate and expand) and that the SVF had worked on the patient with rheumatoid arthritis which at it’s core has a very similar immune dysregulation. We wrote up the first three successive cases and submitted the manuscript for publication. All three patients had a very good response to the treatment, and had no side effects from the intravenous cell treatment (bruising from the liposuction though) and had follow up MRIs. The article, which includes follow up MRIs, can be found here: translational-medicine/content/7/1/29. We also wrote up a case of a lady with rheumatoid arthritis who continues to do very well without further treatment more than 5 years after her single treatment. That article can be found here: intarchmed/content/5/1/5. It is up to the treating physicians which protocol to use. In the case of stromal vascular fraction (SVF) firstly the patient needs to be healthy enough to undergo a liposuction. The doctors also consider the age and co-morbidities (other diseases or conditions) of the patients since both can decrease the number and functionality of the MSCs from the patient. We are currently comparing, retrospectively, the clinical outcomes from patients who have received SVF versus huMSCs for both multiple sclerosis and rheumatoid arthritis. We plan on writing an article for publication on that comparison in the near future. There have been some very good responses in patients just using donor umbilical cord cells. There are two very good reasons for using umbilical cells—they are vetted, young, and robust, and they are off the shelf and do not require the patient to undergo liposuction. We are also starting two prospective studies in parallel, which will compare the outcomes of autologous SVF against huMSCs in patients with rheumatoid arthritis. We currently have protocols for stromal vascular fraction for treating patients with rheumatoid and osteoarthritis. For spinal cord injury we use a combination of the patient’s own bone marrow cells and huMSCs, both intravenously and intrathecally (into the spinal fluid). Regarding SVF, I would like to make one more point regarding same day SVF treatments that are being offered by more and more clinics in U.S. and other countries. These clinics are often representing that they are doing the same treatments that we do at a lower price, oftentimes citing our articles as rationale for treatment. The problems are three-fold. Firstly you cannot possible ensure that the SVF is free of microbial contamination without a 7 day culture. Dr. Caplan who I mentioned earlier famously said in regard to same day treatments, “Same Day, No Way.” Secondly, the amount of liposuctioned material is typically 12% of the amount of product we isolate cells from. In conclusion, most same day clinics are not performing the same procedure, nor performing the quality controls that are done in Panama at our facilities. Thirdly, and most importantly in the case of intravenous treatments (usually for autoimmune diseases), is that MSCs very actively home to areas of inflammation. If you have just had a liposuction and you receive cells intravenously, the cells are going to head right back to the fat was removed and not have much of a chance to interact with the immune cells that are causing the problem. If SVF is used intravenously in our clinic, the patient waits for one week so their liposuction wounds have time to heal and their SVF can be appropriately tested for sterility. SVF treatments that patients receive in facilities doing same day procedures cannot be compared to SVF treatments done at our facility.
Posted on: Tue, 11 Mar 2014 14:30:22 +0000