An allogeneic allograft is regenerative tissue donated from another individual that is applied to diseased or chronically injured tissues in the recipient.

The FDA, under its regulation CFR 361, allows the use of donated human tissue in medicine without premarket review and approval, if the tissue is minimally manipulated, for homologous use, and does not purport to contain a cellular signaling function.

The allogeneic allograft tissue we use at Hawaii Island Regenerative Medicine and Stem Cell Therapy exclusively meets guidelines for FDA exemption under CFR 361, since the donated tissue is designated as a structural support tissue, and is minimally manipulated prior to injection.

A full description of the allogeneic allograft products used at Hawaii Island Regenerative Medicine and Stem Cell Therapy can be found here:  vittilabs.com

In our clinic these products are frequently  combined with allograft products, or PRP, (link here or allograft page and PRP page)so that full cell signaling function can be preserved.

The allogeneic allograft tissue that we use at Hawaii Island Stem Cell and Regenerative Medicine is sourced from umbilical cord donated during  live and healthy C section birth occurring only int her United States.  All of our products come from a lab that is FDA registered and CGMP certified.  In this process, all donors are screened according to accredited Human Tissue Bank standards, and additionally are screened to rule out any infections diseases, inculding COVID vaccination.

In both the laboratory and in small scale clinical trials to date, these products have been shown to be uniquely helpful in regeneration of chronically diseased tissues.   These birth products are a purified portion of the umbilical cord, also known as the Whartons Jelly, and although not intended to provide signaling effects due to FDA regulations, and while no claims can be made as to live cell activity, these products are generally thought to contain live Mesenchymal Stem Cells (MSC’s) live Exosomes (Extracellular Signaling Vesicles) and Polypeptide Enriched Matrix (PEM).1

MSC’s are thought to exert their effects through paracrine signaling, that is, the release of signaling factors to communicate with the surrounding cells and cellular environment in favor of regeneration and repair. In large part, they mediate this signaling effect through exosomes, which are small spherical membrane structures that are released from mesenchymal stem cells to circulate in the extracellular space.  These spherical membranes are packages containing  signaling material, protein, and mRNA, which can turn on genes and genomic proteins of growth and repair in the target tissue, and modulate the immune response in order to reduce inflammation.  And finally, the polypeptide enriched matrix (PEM)  (extracellular) component of the Whartons jelly,  contains the growth media and structural support for the entire system, containing  growth factors, peptides, and hyaluronic acid, to name a few.

Although, due to current regulations we cannot make any claims regarding the effectiveness of these treatments, we encourage you to schedule an initial consultation (include link) with the physician to discuss these options, and to discuss, in the physicians professional opinion, how these treatments may benefit you.