How chiropractors can guide patients to new avenues of non-invasive healing through interventional orthopedics and utilizing stem cells
WHAT ARE STEM CELLS, DO THEY REALLY WORK, how should they be used, are they regulated by the FDA, and what does this mean for DCs are common questions when chiropractors hear about stem cells in clinical use.
Organizations and physicians are using stem cells for a myriad of conditions. Stem cell treatments have been proven effective in bone and tissue healing for arthritis, cartilage degeneration, muscle tears, ligament tears and even in joint replacement prevention.
Other conditions have been reported to have been treated with stem cells, such as multiple sclerosis, Parkinson’s disease, autism and even cancer.
Do they really work?
Stem cells are used as a form of orthobiologic; orthobiologics are defined as “substances that doctors use to help injuries heal more quickly in bones and injured muscles, tendons, and ligaments. These products are made from substances that are naturally found in your body.”
As the body grows and experiences insidious stressors or acute injuries, stem cells support our body’s intrinsic repair system, as they are able to divide into whatever cell is needed to replenish the system. When a stem cell divides it may become another stem cell or transform into a different type of cell with specialized function, like muscle cells or bone cells. Orthopedic technology now allows physicians to use these cells in concentration to help in the healing process.
Stem cells differ from other cell types in that they are:
- un-specialized cells;
- able to give rise to specialized cells;
- capable of dividing and replenishing themselves for long periods.
The two types of stem cells typically discussed are embryonic and adult. Embryonic stem cells are derived from embryos that have been fertilized in vitro. These types of cells are not used in regenerative medicine. Adult stem cells are unspecialized and undifferentiated cells living among specialized cells within a tissue or organ. The main function of the adult stem cell is to repair, maintain and replenish the tissues where they are found. Areas where adult stem cells are found in high concentration are bone marrow and adipose tissue.
How stem cells are applied as an orthobiologic substance:
- After a careful diagnosis of the musculoskeletal issue, a plan is made by a highly-trained physician;
- Bone marrow is aspirated from the patient’s bone;
- The extracted bone marrow is processed with minimal manipulation within a laboratory;
- The bone marrow is re-injected into the affected area with precision using ultrasonic guidance and/or live x-ray within the same day;
- See Figure 1 for an example of a supraspinatus injection under fluoroscopic guidance.
In this process, once the stem cells are re-injected, the stem cells behave like “espresso shots” to wake up the local area and incite an inflammatory cascade to the area of re-injection. The inflammation brings additional healing substrates and growth factors to the area and begins the process of healing.
The initial phase of healing after a stem cell procedure takes up to six weeks. The regenerative benefits will continue to evolve, taking six months to a year to fully actualize. In this time frame, patients usually report decreased pain, improved range of motion and improved function.
What can be treated?
The prevalence of stem cell use is rapidly growing and making waves in the realms of orthopedic medicine. Through the above-stated process, a regenerative medicine procedure can repair bone, muscle, cartilage and tendons throughout the body.
Note that physicians are required to have thousands of hours of experience with injection-based treatment performed using image guidance for a range of body parts and injuries. There are a large number of unscrupulous and frankly illegal activities occurring in this field, which unfortunately taints anyone and everything associated with stem cell treatments. There are currently low levels of research and high concerns about safety when using stem cells for non-orthopedic conditions such as neurodegenerative, cardiac, pulmonary, renal conditions, etc.
Treatment of non-orthopedic conditions with stem cells lacks the large registry tracking outcomes and safety papers that the interventional orthopedic realm provides. Non-orthopedic uses of stem cells are not legitimate and not recommended.
In regard to orthopedic use, these are generally safe tissue targets when applied by highly skilled and trained physicians under precise image guidance in an outpatient setting equipped for resuscitation in case of emergency.
It is the referring chiropractic physician’s responsibility to understand what a legal, legitimate and good stem cell treatment entails, and what a chiropractor’s role in this regenerative medicine process should be.
What is legal?
The U.S. Food and Drug Administration regulates stem cell treatments as Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps) under Title 21 Part 1271, and the exceptions to the regulations are discussed in 21 CFR 1271.15(b).
The regulation has two parts that are relevant:
- Section 361: regulates the use of body tissue and must be registered with the FDA (purpose is to prevent communicable diseases);
- Section 351: regulates tissue that is manufactured and therefore regulated as a drug, device and/or biological product.
Section 361 also has an important exception component. The exception holds as long as that tissue is not more than “minimally manipulated” and is used for “homologous use.” Homologous refers to use of the tissue for the same purpose it already serves in the body.
The FDA argues that it has the authority to regulate anything beyond minimal manipulation and homologous use as a drug, device and/or biological product. Therefore, the tissue is not regulated at all by the FDA if it is used in the same patient during the same surgical procedure, is no more than minimally manipulated or is used for homologous use.
How the FDA views the following tissue products:
Bone Marrow Concentrate: Allowed.
This is not under FDA regulatory control, and is exempt from Section 361 and not regulated by Section 351 as long as it is minimally processed and placed back into the same patient during the same surgical procedure and has homologous use.
Adipose-derived Stem Cells (Stromal Vascular Fraction): Not allowed.
This is regulated as a drug under Section 351 (currently no drug approvals exist for this). The act of breaking apart the fat to get the stem cells requires an external enzyme, and is therefore considered more than minimal manipulation.
Culture Expanded Stem Cells from Bone Marrow or Adipose: Not allowed.
This is regulated as a drug under Section 351, with more than minimal manipulation.
Fetal Stem Cells: Not allowed.
Aside from potentially ethical issues, this is illegal to use in the U.S.
Amniotic, Placental or Umbilical Tissue Products: Allowed.
Tissue products regulated under Section 361 are all sold in the U.S.; however, none of the products sold in the U.S. contain living stem cells.
Amniotic, Placental or Umbilical Stem Cells: Not Allowed.
These are regulated under Section 351 as a drug. No commercial products in the U.S. contain stem cells, and they have been independently tested and do not contain living cells.
Legitimate and proper treatments
Often patients with orthopedic conditions will fail a conservative trial and course of care. Then what should they seek? Surgery that can be overly invasive and cause other issues? Steroid injections that are catabolic rather than healing? What happens when they tell you they’ve sought stem cell therapy? Where should you send them if you think they may be a good candidate for stem cell therapy?
When evaluating stem cell therapy:
- Physicians should be performing the procedures and should be adequately trained
- Appropriate tissue sources should be used, based on current FDA regulations involving minimally manipulated bone marrow
- Appropriate image guidance should be used: ultrasound and/or fluoroscopic guidance (see Figure 2)
- Appropriate equipment and training for resuscitation should be available
- Published research should guide decision-making and support claims
- Patients should be tracked in a registry
- Marketing materials and claims must be accurate
- FDA actions should be monitored by state boards
The chiropractic role with stem cells
The chiropractor’s role is to diagnose and treat conditions within our scope of practice. We provide care for musculoskeletal conditions using tissue and joint manipulations, and appropriate holistic lifestyle counseling to support patient healing and wellness. Some state boards, like those of Oklahoma and Colorado, allow injectable therapies; however, most do not.
Some chiropractic marketing groups created programs offering chiropractors a lucrative model including NPs/PAs and loose physician oversight. This model includes a non-surgical orthopedic treatment scheme with regenerative medicine products marketed as stem cells, when it’s truly a non-living birth tissue product.
Chiropractors can play a significant role in this treatment process by practicing excellent case management for recalcitrant orthopedic cases, and by ordering imaging and advising patients to consider the best non-surgical options. Then, by understanding how these cases are best managed, we can advise the patients about things to look for or be wary of when pursuing a stem cell treatment.
Chiropractors can also play an integral role in the patient’s preparation for and recovery from stem cell procedures. We can form a clinical alliance with the physicians trained in performing these procedures and provide pre-habilitation and rehabilitation for patients.
ABBY PERONE, DC, CES, CF-L1,is a graduate of Parker University. In 2010 she was selected to be on the sports medicine team for the Colombian Olympic Committee in Bogota, Colombia, and served on the sports medicine team for an NASL soccer team, the San Antonio Scorpions. She served on the Airrosti Athlete Services team for multiple CrossFit regional events and the CrossFit Games from 2013-16. She can be contacted through rocktape.com.