- Source: Allogeneic/Allograft Tissue (from a donor)
- Treatment Areas: Large and small joints, muscles, tendons and ligaments
- Stage of Arthritis: Mild, Moderate or Severe
Some patients simply do not want to go through the processes of harvesting their own stem cells or platelets (autologous procedures using bone marrow aspiration, a mini-liposuction or blood draws).
Studies show umbilical cord tissue (Wharton’s Jelly) injections are the best alternative to autologous procedures because they contain larger amounts of critical growth factors and cytokines that facilitate the healing process in your joints when compared to other off the shelf allogeneic products.
About Wharton’s Jelly Treatment
How is Wharton’s Jelly used in joint regeneration, cartilage, muscle, tendon and ligament repair?
Wharton’s Jelly is a rich mixture of human cell and tissue products including exosomes, super charged protein growth factors, cytokines, natural hyaluronic acid, scaffolding and possibly mesenchymal stem cells. (See below section on live stem cells in allogeneic products). After a brief thawing process, the Whaton’s Jelly is injected into the damaged joint or area of tissue damage. These healing components initiate a biological cascade that repairs and regenerates damaged tissue.
How are Allogeneic/Allograft tissue laboratories regulated in the United States?
The United States Food and Drug Administration carefully oversees and regulates all US based laboratories that manufacture Wharton’s Jelly products. They perform an audit on US laboratories every three years.
Is Allogeneic/Allograft tissue Safe?
Per FDA guidelines, all donors of allogeneic products are subjected to a comprehensive review of their medical history, and they are extensively screened to exclude numerous infectious diseases. In addition, these products themselves are also tested for infectious diseases once they are donated and processed.
Who is a candidate for treatment utilizing Allogeneic/Allograft tissue products?
Allogeneic tissues can be used for exactly the same medical conditions that autologous stem cells and PRP are used for. They are simply another option for patients that do not want the inconvenience of harvesting their own stem cells or platelets.
Is the procedure painful?
The vast majority of patients feel only a bit of pressure during the procedure. In cases where the patient may feel discomfort, the medical provider takes care to numb the surface of the skin. The entire injection process only takes a few minutes.
How long before I can expect results?
This depends on the severity of the underlying joint, muscle, tendon or ligament problem and patient’s adherence to physician-recommended post-procedure protocols, like physical therapy. In our experience, most patients begin to see results in 3 to 4 weeks, and gradual improvement continues for 6 to 8 months afterwards.
Are there live Stem Cells in our Wharton’s Jelly products?
This is a topic of much debate amongst medical doctors who are experts in the stem cell field, the Food and Drug Administration, and Allogeneic/Allograft tissue laboratories. Below we will attempt to provide an unbiased analysis of this debate:
Medical Doctors (MDs):
Most MDs around the country who are experts in stem cell therapy take pride in the fact they have the skill set to harvest bone marrow and adipose tissue stem cells from their patients. Therefore, they typically do not believe there are live stem cells in any Allogeneic products. These MDs are certain they are delivering live stem cells to their patients through the harvesting process and are not interested in joining the stem cell debate regarding allogeneic products. More importantly, they prefer to follow the guidance of the FDA (see below).
Food and Drug Administration (FDA):
In 2017, the FDA announced that in November of 2020 they would make a ruling on how they classify all allogeneic products. With so many clinics out there making false treatment claims regarding stem cell therapy and many laboratories making false claims about what is actually in their products, the FDA essentially gave all clinics and laboratories 3 years to comply with their current guidelines.
Here are the current FDA guidelines regarding the use of live stem cells for treatment of orthopedic conditions:
Live stem cells are allowed by the FDA under 2 sections of the Public Health Service Act (Section 351 and 361) which provides the authority for FDA to establish regulatory requirements for marketing traditional biologics and human cells, tissues, and cellular and tissue-based products.
These two pathways differ markedly in terms of the time, effort and expense required to bring these products to market in the U.S. One is the simple 361 registration, and the other is the complex 351 cell-drug approval.
All of the Allogenic products on the market today claim to operate under the simple 361 registration, which, unlike a drug approval, requires no clinical trials or data. However, if a product claims to contain live stem cells, then it does not meet Section 361 criteria, and according to the FDA it must be registered and regulated as a drug under Section 351.
Allogeneic/Allograft Tissue Laboratories:
Many FDA regulated laboratories have done extensive research claiming the presence of live stem cells in their allogeneic products. After doing our own research, NeoGenix has chosen Predictive Biotech as our laboratory of choice. Below we have provided an informational video from Predictive Biotech, as well as other white papers and clinical studies claiming there are live stem cells in Wharton’s Jelly.
Informational Video from Predictive Biotech:
Research Articles and
Because of COVID-19, the FDA has pushed back their ruling on all allogeneic products until May of 2021. Until then, NeoGenix is going to comply with the current FDA guidelines and not claim live stem cells in the Wharton’s Jelly product we use. We suggest our patients do their own research and determine what they believe for themselves until the FDA makes a ruling. It should also be noted that Predictive Biotech has started Section 351 cell-drug approval process.