Position Statement on Stem Cell Treatments
Warner Orthopedics and Wellness’s Approach To Stem Cell Treatment
At Warner Orthopedics and Wellness, we only utilize adult mesenchymal stem cells. We never process or grow stem cells, and we never use embryonic tissue.
We strongly believe in the promise and potential of regenerative medicine. That being said, we also wish to provide a safe and effective service to our patients and clients and to follow the current regulatory framework.
We have reviewed the 2017 position statement put forth by the Food and Drug Administration (FDA) and a warning letter sent to Genentech by the FDA in 2018. In addition, we have also reviewed the Louisiana State Board of Medical Examiner’s position statement. Our current policies fall within what we believe the FDA and the State approve with regard to these treatment methodologies.
Our goals for these treatments are to protect our patients from any unproven treatments that may be harmful. In addition, we do not wish to financially exploit our patients with these very promising but uncovered by insurance treatments. Our goal at Warner Orthopedics and Wellness is to provide an ethical regenerative medicine treatment program.
Treatment of Conditions with Stem Cell Therapy
Stem cell therapies have massive potential for the treatment of many orthopedic and podiatric conditions. Here, we only treat conditions that are within what we consider to be our scope; that is, we will use regenerative medicine for orthopedic and podiatric problems and conditions but will not venture into treatments for other maladies such as Alzheimer’s, MS, etc. We believe that other providers are better trained in those specialties and better able to treat and educate the public and patients for those conditions.
We also do not believe there is enough safety data out yet to ever recommend stem cell therapies for children or pregnant women, therefore we will not offer this service to those groups.
In orthopedic surgery, adult mesenchymal stem cells have been used for decades; we have merely transferred them by way of bone grafting. Now, we have the technology to separate the cells from the bone marrow and eliminate the need for painful transfers of large amounts of bone.
Bone grafting and the mixing of bone marrow with synthetic or cadaver-derived bone graft has always been allowed and approved by the FDA in orthopedic and podiatric surgery. It still is so. We employ the same protocols but in a much less painful way.
Additionally, we only utilize FDA-cleared processing equipment that has been well-accepted within our industry for years. Although this equipment is expensive, it is approved, accurate and safe. The system processes platelet-rich-plasma, leucocytes, and hematopoietic cells based on the hematocrit number in the sample. We have the ability to tell the system what type of blood and marrow tissue we prefer to concentrate.
Bone marrow harvesting has been a long accepted medical practice. Bone marrow harvesting and subsequent concentration of adult mesenchymal bone marrow cells is considered by the FDA to fall outside of premarket administrative requirements and is allowed in our understanding.
The Relevant Language of the FDA Regarding Bone Marrow Concentration
In 21 CFR 1271.10, the regulations identify the criteria for regulation solely under section 361 of the PHS Act and 21 CFR Part 1271. An HCT/P is regulated solely under section 361 of the PHS Act and 21 CFR Part 1271 if it meets all of the following criteria (21 CFR 1271.10(a)):
- The HCT/P is minimally manipulated;
- The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent;
- The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and
- i) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
- ii) The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
- a) Is for autologous use;
- b) Is for allogeneic use in a first-degree or second-degree blood relative; or
- c) Is for reproductive use.
If an HCT/P does not meet the criteria set out in 21 CFR1271.10(a), and the establishment that manufactures the HCT/P does not qualify for any of the exceptions in 21 CFR 1271.155, the HCT/P will be regulated as a drug, device, and/or biological product under the FD&C Act, and/or section 351 of the PHS Act (42 U.S.C. 262), and applicable regulations, including 21 CFR Part 1271, and premarket review will be required.
Processes of Harvesting the Necessary Bone Marrow
At our practice, we harvest bone marrow from an adult’s own iliac crest, proximal tibia or calcaneus in a sterile surgical setting with FDA-cleared equipment and appropriate anesthesia. We then minimally manipulate it with a centrifugation system that happens in the surgical suite.
During the same procedure on the same day, we then perform the autologous (Self-derived) and homologous (similar tissue type) transfer. We believe that our practice meets the FDA requirements as set forth above.
At this time we do not offer any adipose-based stem cell treatments as we believe they do not meet the requirements above. It is our current understanding that the adipose is structural tissue that is more than minimally manipulated. We also do not send our marrow harvests off for further processing or growth; this too violates recommendations from the FDA.
FDA Restrictions on Stem Cell Therapy
The FDA sent letters to stop practices employed by Genentech and Regennex and the US Stem Cell Clinic recently. Even more recently, the FDA is seeking permanent injunctions against the US Stem Cell Clinic. As well the following is taken directly from the FDA website:
“The FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center Inc., with locations in Rancho Mirage and Beverly Hills, California; Cell Surgical Network Corporation of Rancho Mirage, California; and Elliot B. Lander, M.D. and Mark Berman, M.D., from marketing to patients stem cell products without FDA approval. Berman and Lander control the operations of approximately 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center.”
The FDA has also sent a warning to the American CryoStem Corporation for its unapproved product Atcell. Stem Immune in California has also received a letter for adipose-derived cells.
In 2014 the Supreme Court upheld a decision by the FDA to stop Regenerative Sciences LLC from marketing Regenexx-C.
Ethical Regenerative Treatments at Warner Orthopedics and Wellness
We strive to perform the most optimal procedure for our patients. For pain and performance issues associated with muscle, bone, joints, ligaments, and tendons, stem cells and associated PRP treatments hold a great deal of promise. These are far less invasive and have fewer possible side effects than surgery.
For further questions about our processes regarding adult mesenchymal stem cell therapy or to schedule an appointment, contact us at Warner Orthopedics and Wellness today.