Stem Cell Therapies
Regenerative Cellular Therapy Treatment
Why Stem Cells?
- FDA approved, it is the next chapter in organ transplantation and uses cells instead of donor organs.
- Treatment only takes ten minutes or less through injection.
- What We Treat: Hip, Shoulder, Elbow, Back, Neck, Ankle, Foot and Knee injuries.
- Stem cells are obtained from the sterile umbilical cord blood of screened eligible donors.
- All stem cell material is tested by a third-party lab for sterility and must pass regulatory requirements before distribution.
The FDA recently confirmed there is only one registered and approved stem cell product on the market: umbilical cord blood-derived hematopoietic progenitor cells (blood-forming stem cells) used for certain indications. While there is enormous promise in stem cell therapies, and thousands of ongoing experiments trying to establish efficacy, stem cell treatments do not yet meet the FDA’s scientific approval standard.
Practitioners tapping into this enormous promise of stem cells for any therapeutic use must exercise their professional judgment and expertise. We urge anyone embarking on the use of stem cell therapies to consult the national health databases to evaluate current clinical trial information, and the FDA’s website on human tissue to get its current therapy evaluations.
In 2018, the FDA’s commissioner and research director reported that the agency will be incorporating some “new concepts for how small investigators and firms can seek and meet the approval standard for products through efficient expedited pathways.” You can keep up with the latest developments on the FDA’s website.
Most patients tolerate stem cell injections well, with few or no side effects. However, all medical procedures present the possibility of side effects. Most commonly reported are slight pain or soreness near the injection site. As with any other injection procedure, there is a small risk of bacterial infection NOT associated with the cellular product.
Discuss your medical history, expectations, and any medications you’re currently taking with your doctor. While most people are good candidates for stem cell injections, certain medical conditions may interact with stem cell therapy.
If you experience any severe or prolonged side effects, don’t wait—contact your healthcare provider or seek emergency medical attention right away.
Stem cells are processed from the umbilical cord blood of healthy newborns. If a pregnant woman scheduled for cesarean section decides she does not want to keep and store her unborn child’s umbilical cord, her OB/GYN asks whether she would like to donate it. After an informed consent form is signed, a medical and social history review is conducted, as well as a blood test.
If the new mother meets all donor eligibility requirements, she is accepted as a donor. After her baby is born, the umbilical cord blood is collected in a sterile collection bag and sent to a lab.
The cord blood is processed within 48 hours using proprietary methods. A sample of the finished product is tested by an independent third-party lab for sterility. Only after all lab reports have passed the regulatory requirements can the umbilical cord stem cells be distributed.