When considering a stem cell treatment, it’s very important that you fully understand the source of the stem cells that will be inserted into your body as well as the way in which the cells were harvested, processed, stored and distributed.
At Regen Orthopedics, we follow what is considered the gold standard of regenerative medicine for orthopedics. This protocol uses a patient’s own adult stem cells. Learn more about this here.
But some providers use donated stem cell “products” that are not what they seem to be and may not be legal in the United States. If you are considering a treatment that uses donated cells from amniotic or cord blood sources, you may receive a product that actually contains dead stem cells and is not likely to work. The clinics offering them may not even specialize in orthopedics. See more here.
Do your research, and ask these questions:
- How are the stem cells obtained from the donor and transferred to the recipient?
- What is the process to keep the cells viable (alive) and how can you prove that the cells are not dead tissue? Is there viability testing performed by an independent company or lab?
- What testing was done beyond simple live/dead viability testing? For example, have these cells been grown in the lab after the product has been thawed per the package instructions? (And if so, this would be against FDA regulations concerning manipulating cells that are to be injected in a patient from a donor.)
- Is this stem cell product FDA approved and has it gone through FDA trials? If the stem cells contain live cells from birth tissues, it would be considered a 351 drug that needs to go through rigorous FDA trials. Ask if the vials you are receiving are from an approved FDA study. (Note that there are currently no approved stem cells products in the US for use in orthopedic applications at this time.)
- Is the research on your stem cell product performed on live birth tissues in a lab or on the frozen product that you actually inject into patients?
- How do we know that the cells in the product are in fact stem cells? Do you have proof of flow-cytometry data that follows the ISCT standards to identify mesenchymal stem cells (MSCs)?
- Is the product gamma-ray terminally sterilized? Is the product sterilized using any method before it leaves its place of manufacture?
- Has your stem cell product been tested with human stem cells to see if it helps them? For example, has the product been tested as a “stimulant” or adjuvant with older human MSCs in culture?
- Do we know if the tissue works any better than an autologous PRP/BMC shot? For example, has the product been tested versus PRP to stimulate human MSCs in culture, and if so, what are the results? If the product has growth factors (GFs) and no stem cells, how do those growth-factor levels compare to PRP/BMC? For example, have these GF levels been assayed and compared to those found in PRP/BMC?
- If this product is as good as you claim, are you willing to have a nonprofit put it through rigorous testing that will compare it to other birth tissue products? For example, the IOF (a 501c3 nonprofit) has tested many birth-tissue products and compares them to each other as well as to PRP/BMC.
If the clinic offering donated stem cell products cannot answer these questions, consider that a red flag before letting them inject these cells into your body. Make sure you are being seen by an orthopedic specialist who fully understands regenerative medicine and its applications for orthopedic conditions.