What is the purpose of regenerative medicine?
Regenerative medicine is used to repair and regenerate tissue damage. This includes cartilage, ligaments, tendons, and bones. When people develop musculoskeletal injuries, they normally go through pain management that includes prescription medications. While pain management masks the pain, it does not heal the injury. For instance, corticosteroid injections reduce pain and inflammation but do not speed up the recovery process. Once the injections wear off, the patient may still be injured, and the pain could come back.
Instead of providing a band aid solution like pain management, regenerative medicine repairs the tissue. Stem cells and platelets jump-start the body’s natural healing process. Patients can actually improve after regenerative medicine treatment.
What are stem cells, and what makes them special?
Stem cells are essentially blank slates. They can differentiate into various cell types, such as cartilage, tendon, bone, skin, or red blood cells. Stem cell therapy uses stem cells to increase the number of specialized cells needed to repair soft tissue or bone. By boosting the number of specialized cells, the recovery time is shortened.
What types of stem cells are there?
Stem cells are divided into two categories, which are unlimited and limited. Unlimited stem cells (embryonic stem cells) can turn into any type of cell. Specialists can replicate the cells outside of the body and then inject them to treat conditions. We do not use any embryonic stem cell products at Revive MD Center.
Limited (adult) stem cells cannot be replicated outside of the body, so physicians transplant them after extracting them or freeze them for later use. Adult mesenchymal stem cells (MSC) are harvested from health donors and processed under strict regulatory guidelines in FDA cleared facilities. Our center only uses adult MSC products to include amniotic ad umbilcial cord products. Hence none of them are considered controversial. Known as the “products of conception”, the regenerative materials from amniotic and umbilical tissue include the following:
- Amniotic Fluid
- Placental membrane
- Umbilical Cord Tissue
- Umbilical Cord Blood
- Wharton’s Jelly
The exact function of these materials supporting growth and health of the fetus is outside the scope of this guide. However, understand that a lot of the functions provided during fetal growth translate into patient benefit during regenerative procedures such as preventing infection and tissue growth of all types such as collagen, tendon, lung, kidney, heart, etc.
Research performed on the products of conception have shown several benefits to what the materials contain including:
- High numbers of Stem Cells
- Concentrations of Growth Factors
- High numbers of Cytokines
Additional elements including exosomes, microsomes, secretomes, mRNA.
The best analogy applicable is that the products of conception produce regenerative materials that contain a full “orchestra” of components to treat patients!
Note: You may see competitor marketing materials that state “products of conception” do not contain live cells. This is true if the biologics are radiated during processing or contain too much preservative. But it is not true if the materials have been processed without significant radiation or preservatives. This is why we are VERY careful about the labs we work with so patients receive products that are safe and of the highest quality to produce the best outcomes possible!
Do physicians use regenerative medicine in their practices?
Absolutely. Countless pain management and orthopedic practices have embraced regenerative medicine.
Are these products FDA approved?
No they are not. They are not regulated as drugs, rather they fall into the biologics category. These are regulated heavily by the FDA, but do not get approved or denied.Here is how the FDA regulates things:
Medical devices – joint implants, screws/rods, DME, etc. In the world of regenerative medicine, this only applies to the kits used in PRP, bone marrow or adipose procedures.
Drugs – think of Lipitor, Vicodin, Viagra, etc. These are medications that have gone through a clinical trial and been approved for a specific indication.
Biologics – the FDA strictly regulates how biologic materials are acquired, processed, stored and used under the CFR Part 1271. Amniotic and umbilical materials fall under this category, which does not involve an Approval/Denial process like drugs do.
Specifically, the section under Part 1271 that applies to amniotic/umbilical tissues is Section 361 products, which are not required to be licensed or approved by the FDA and are regulated under Section 361 of the Public Health Service (PHS) Act.
Is one type of stem cell better than the other?
Theoretically the answer is yes. However, it’s currently not clinically relevant. Embryonic stem cells are pluripotent and can differentiate into over 200 cell types.
However, there are ethical concerns over how they are obtained, and also the cells themselves often do not know when to stop replicating. This can form tumors.
The non-embryonic adult mesenchymal stem cells obtained from one’s bone marrow, amniotic fluid or umbilical cord can still differentiate into several important cell types, but not 200.
This is called being Multipotent and able to turn into cartilage, muscle, tendon,ligament and most vital organ cells. Multipotent stem cells have not been shown to form tumors like the pluripotent variety.
What type of procedures are available for Stem Cell Therapy?
Procedures available for stem cell therapy include localized or IV injection with amniotic or umbilical cord derived stem cell therapy.
The procedures are all performed as an outpatient, with each procedure taking less than an hour. With the amniotic or umbilical cord therapy, the fluid is obtained from consenting donors after a scheduled C-section. Then it is processed at an FDA regulated lab and cryogenically frozen and thawed out right before use.
Clinics use regenerative medicine to treat a variety of conditions, including arthritis, tendonitis, cartilage defects, diabetic neuropathy, fractures, hair loss and aging. The practitioners treat these conditions with platelet-rich plasma therapy, amniotic-based stem cell-rich injections and umbilical cord derived stem cell injections.
Have scientific studies proven the effectiveness of regenerative medicine and musculoskeletal conditions?
Large-scale scientific studies still must be conducted regarding regenerative medicine and musculoskeletal conditions. However, researchers have conducted several small studies with animals and humans as subjects. The results of these studies have been positive. The results support the hypothesis that regenerative medicine is key to improving musculoskeletal conditions.
Does insurance cover stem cell therapy and other regenerative procedures?
If the condition is determined to be musculoskeletal and sports injuries, insurance may be able to cover the cost of treatment based on clinical necessity and documentation on a case by case basis. Most insurance policies do not cover aesthetic regenerative procedures.
How much does it cost to get a regenerative medicine treatment?
Various factors determine the cost of the procedure. Patients can find out how much their treatment will cost during the consultation as Revive MD Center clinicians will discuss a treatment plan with you during your visit.