317 St. Francis Dr. Suite 350
Greenville, SC 29601

317 St. Francis Dr.
Suite 350
Greenville, SC 29601
Tel: 1-864-235-1834, Fax: 1-864-235-2486

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Wharton’s Jelly for Homologous Tissue Support

Wharton’s Jelly for Homologous Tissue Support

Wharton’s jelly is the gelatinous substance within the umbilical cord.  It provides insulation and protection within the umbilical cord.  It is a gelatinous substance made largely from mucopolysaccharides. It contains a host of growth factors, cytokines, pathway signaling molecules, and stem cells that have regenerative properties.  Wharton’s jelly also has several other favorable characteristics including strength, flexibility, cushioning, covering, compressibility, and response to friction and shear.

Hyaluronic acid is the most abundant component of the glycosamnioglycans found in the umbilical cord matrix. Hyaluronic acid is also a key factor in the viscoelastic properties in synovial fluid of joints.

Since Wharton’s jelly provides tissue support within the umbilical cord blood, and since these characteristics are part and parcel of its original biologic use, the FDA has ruled that Wharton’s jelly is a homologous derivative for joints, tendon, ligament, and other musculoskeletal applications.

In the United States Wharton’s jelly derived mesenchymal stem cells are harvested, along with other growth enhancing factors, from full term neonates with written consent of the family.   Current FDA Guidelines state that, among other things, processing cannot alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction and repair, and that replacement and processing cannot alter the relevant biological characteristics of host cells or tissues.

Since 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, Wharton’s jelly is an excellent regulatory fit.  Furthermore, Wharton’s jelly derived mesenchymal stem cells do not produce teratogens or carcinogens after subsequent transplantation.

It is quite fair to say that processing and purification procedures today have to follow strict FDA guidelines.  While such regulation can at times interfere with innovation, they do provide the public with a level of comfort, safety, and transparency as well. Since Wharton’s jelly is compliant with all aspects of regulation, and clinical results to date have been promising, in all likelihood as time goes on you will be hearing more about Wharton’s jelly for regenerative medicine applications. What is more, there are already several publications that have shown excellent clinical results with Wharton’s jelly applications.  Since ongoing research is robust it is likely that this trend will only continue to grow and expand.