11 Oct FDA 361 Compliant Wharton’s Jelly Umbilical Cord Allograft is Available
Umbilical cord allograft tissue made with Wharton’s Jelly can be compliant with current FDA 361 regulations. While many doctors/clinics using autologous bone marrow or adipose tissue would like you to believe none of it is compliant, it’s simply not true. (They say that falsely for competitive reasons.
FDA Definition of Minimal Manipulation Tissue
When it comes to regenerative allograft tissue, the FDA has two regulatory categories. One of these categories is termed “minimal manipulation”. What does that mean? Well the FDA divides it into 2 definitions:
1) For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement;
2) For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues
Along with the FDA’s verbiage on minimal manipulation compliance, they have also stated, “Tissues that physically support or serve as a barrier or conduit, or connect, cover, or cushion in the donor are generally considered structural tissues for the purposes of determining the applicable regulatory definition. “
Examples of structural tissues include:
- Amniotic membrane and umbilical cord;
- Blood vessel;
- Adipose tissue;
- Articular cartilage;
- Non-articular cartilage; and
- Tendon or ligament.
Please note that the FDA included “umbilical cord” in its definition of tissue that may fall into the minimal manipulation category. Processing umbilical cord tissue so that it continues to serve its structural support function is important. The FDA is clear that various enzymes should be avoided, along with expanding “culturing” the product.
To complete this section, ReBellaWJ does fit the criteria for a minimally manipulated product. The processing is performed very carefully, and the result is a tissue that performs an amazing structural support function.
The second criteria is that a minimal manipulation product be used in a “homologous” fashion. Initially one might think of “homologous” as meaning being used in the same species. But that would be incorrect! The same species part is already assumed, and the FDA definition of homologous use is “having the same function in the recipient as it had in the donor.”
So if one looks at the function of the umbilical cord in the donor, a significant function is to provide structural support with protection, cushioning and lubrication. When a minimal manipulation umbilical cord tissue is used in a soft tissue or joint procedure, the function is the same! By providing this function, pain can be dramatically relieved in patients.
This is referred to as being an FDA 361 compliant product. If the product does not fit that criteria, it becomes an FDA 351 product, and is regulated as a drug.
As a primary function, homologous use needs to be maintained. In addition, the FDA states that the tissue can also have a secondary local metabolic effect, but not a systemic effect. What does this mean? Without delving too much into basic science, what it means is that it is fine if the umbilical cord tissue has cytokines, growth factors, exosomes and stem cells which produce a local metabolic function.
So all of the companies that mention if umbilical cord tissue has live cells then it’s automatically a “drug”, are wrong. Having live cells and other elements is fine as long as they are not producing the primary structural support function.
The FDA has made this very clear. What they have also published are examples of usage that do not constitute homologous use. For example, using a Wharton’s Jelly product systemically to assist with cerebral palsy is not structural, but more in having a systemic effect. So one needs to look at each case use.
In conclusion, ReBellaWJ is a minimal manipulation product that has plenty of options for homologous use in clinical situations. To order, contact Regen Suppliers today at (888) 568-6909 or email email@example.com today.