Allogeneic allograft regenerative tissue therapy using donor tissue for treating chronically injured or diseased areas under FDA CFR 361 guidelines
Allogeneic Allograft
June 26, 2026

Cosmetic Regenerative Medicine


At Hawaii Island Stem Cell Therapy and Regenerative Medicine , we offer advanced regenerative facial treatments and Hair loss treatments for me using a combination the following products:
Autologous Platelet Rich Plasma (A concentrate of the patients own platelets)

 Allogeneic Allograph.  Umbilical cord tissues harvested in an accredited tissue bank form live c section birth, containing MSC’s, exosomes, and polypeptide enhanced Matrix, regulated under FDA CFR 21.

How Do these products Work in Facial Aesthetics and Hair Loss?

Autologous Platelets via PRP can be injected under the patients skin at the site of hair loss or visible skin degeneration, such as wrinkles, and age marks. Umbilical allograft materials are applied to the skin directly via microneedling.

Allogeneic Allograft  

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.

When used in these way, both of the biological materials are thought to:

Stimulate collagen and elastin production

  • Reduce redness, puffiness, and inflammation
  • Accelerate healing 
  • Improve skin tone, texture, and firmness
  • Support natural repair of fine lines, wrinkles, and sun damage
  • Improve circulation
  • Restore hair follicle activity ion appropriate areas through regeneration of the hair follicle until, including via circulation and growth factor effects 

These effects are not superficial. These treatments work at the cellular level, encouraging long-term health and regeneration.

Preliminary scientific data both in humas, and animal models supports the claims that these treatments can restore hair loss and counteract the effects of skin aging.

Natural Results, Backed by Science

Whether you're looking to refresh your skin, recover faster from cosmetic procedures, or enhance your glow naturally, cellular therapy vias PRP or umbilical allograft  therapy is a safe, non-surgical solution with powerful results.

References

  1. AH Amol H Trivedi, et al. "The Categorization of Perinatal Derivatives for Orthopedic Applications." Biomedicines, 2024.
  2. On the appointments page and on the contact form page, I get the following error message when I attempt to spend a contact: “There was an error trying to send your message. Please try again later.”  Can you fix, please?
  3. On the appointments page footer, change text to the following:
  4. Please allow up to one hour for the initial visit with your physician.
  5. The cost of the initial evaluation is $150 and includes written treatment plan and cost estimate.   The $150 can be credited towards the cost of your initial treatment.

The forms on this page are outdated,  we can just take them off the page at this time, since my staff will send all interested patients electronic forms.