Orthobiologics – “Stem Cells,” Amniotic derived products
It is true that these products have been studied extensively around the world and have been found to be beneficial in helping restore and regenerate tissue. We attend global orthopedic conferences 1-2x/year to ensure we are bringing you the latest and greatest treatment options available around the world.
Orthobiologics are biologic product used for orthopedic purposes. They include but are not limited to PRP and amniotic product. Another important product is exosomes (see other page on our website). These treatment options help with healing and expedite recovery while avoiding steroids and surgery. Many athletes and active individuals of a wide range of ages opt for this option. Recovery is faster, less expensive, and easier than surgery.
There are several keys to making these treatment options successful. We discussed the keys with PRP on the PRP page of our website (please reference). Here, we will focus on amniotic product (namely amniotic fluid and cord blood “Wharton’s jelly”). Like with so many things in life regarding quality, not all amniotic product that is available is equally safe or effective.
This is a complex subject that gets oversimplified in the industry. “Stem cell” is a misnomer and illegal mis-marketing. Many practices are now being investigated due to the claim of providing stem cells.
So, what are we actually providing? The proper term used for these biologic products used for orthopedic purposes is “Orthobiologics.” The term is not yet mainstay but will be going forward. Amniotic derived products that we inject at Full Circle are chock full of healing properties called growth factors and other key players (including hyaluronic acid, extracellular matrix, and cytokines). We mentioned the growth factors found in PRP through concentrated platelets in the PRP section of our website. The difference between PRP and amniotic product is the age and “power” of the growth factors and healing properties. The company we use derives the amniotic product from consenting Mothers who undergo full term viable infant scheduled C-sections and who provide their infant amniotic fluid, sac, and umbilical cord. The Mothers are not compensated for this product. The product is then transferred to an amniotic storage and processing lab that meets rigorous standards called cGMP compliance. Most of these labs have been in business for 20+ years for many uses, namely in childhood cancers. Each batch is thoroughly tested for viruses and infections and the cells are evaluated for quality acceptance before they are released in the market. We do offer these products at Full Circle, and they are offered at other practices under IND (investigational new drug study) status. We highly recommend an in-depth discussion about appropriate use and realistic expectations.
The goal of this treatment option is to:
- Decrease pain
- Decrease inflammation
- Improve function
- Heal the injury including small or partial tears
- Prevent further degeneration process
- Delay or avoid need for surgery
- Clean and anesthetize the area being injected
- Thaw frozen amniotic derived product for 5-15 min
- Inject thawed amniotic derived product into area of need using ultrasound guidance
- Relax in observation for 10-15 min
- Follow up in one month
It is normal to feel sore for 2-3 days. Take time to rest and “listen to your body” during the first week. Eat well and rest more than usual. It will be worth it in the long run.
Avoid anti-inflammatories topically and orally for 7 days following the treatment. You may use over the counter analgesics (Tylenol, lidocaine) instead. Use of ice is discouraged.
Usually, you are back to PT or light sport by day 10-14 and back to full-fledged exercise or sport in 30 days. You may do other exercise not using the affected limb in the initial phase. This will be discussed more fully on an individual basis.
It takes 6-12 weeks on average for the “full effect” but can take up to 6 months.
RISKS AND COMPLICATIONS?
The two components that pose risk are the injection itself and the product injected. Some possible risks include but are not limited to the following. Most all except increased soreness afterwards are extremely rare.
- Increases pain after treatment
- Allergic reaction to product
- Unexpected reaction to product
- Immune reaction to product
- Transmission of disease
- Damage to nerve or other tissue
It is most valuable to schedule a consultation to discuss your issue, goals, and whether amniotic derived treatment is the best option for you. We look forward to meeting you!
WHAT WE KNOW NOW AND WHAT IS THE FUTURE:
“True” stem cells need to be cultivated (aka expanded or grown) in a lab and then reinjected into the patient. Currently, this is primarily used for cancer and other non-orthopedic purposes. However, there are a few of these “true” types of procedures being performed currently in Orthopedic surgery. One is called Matrix-Induced autologous chondrocyte implantation (MACI). This is a two-step surgical process. First, you undergo arthroscopic surgery to take a biopsy of your own joint cartilage. Next, it is cultivated (aka expanded or grown) in a lab. Then, you have another arthroscopic surgery to apply the expanded cartilage to your joint. It is FDA-approved cartilage restoration procedure that uses your own cells to repair cartilage defects in your knee. In simple terms, it has not been shown to last long enough to warrant the cost and the risk of two step surgical procedure. If you are interested in this option, we can refer to an orthopedic surgeon to discuss more fully.
Ongoing research is dialing in further options in the joint preserving and restorative arena. Currently, one new product gained FDA approval called Agili-C which is a coralline aragonite (inorganic calcium carbonate) used as a plug surgically placed into a single area of cartilage defect. Insurance coverage and coding are not yet solidified. Another product is a porcine derived scaffold implanted on the cartilage to help grow more of your own cartilage. Again, these options are in beginning stages but hopefully will be readily available in the next few years.