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
Barbotage
August 25, 2020

Urogenital Regenerative Medicine For Men


A large amount of Grade A scientific evidence shows that Platelet Rich Plasma injection into the penis leads to dramatic and permanent improvements in sexual function, including enhancing size, girth, sensitivity, erectile function, and even ejaculation control! This therapy can also be used to treat diseases of the penis such as erectile dysfunction, Peyronie’s disease, and lichen planus. Birth tissue allograft products can also be used in combination with or to replace PRP.

PRP

PRP stands for Platelet Rich Plasma. Platelets are powerful particles in the blood that normally concentrate at an area of injury and set off a signaling cascade that tells the body to heal or rejuvenate a damaged area. You can see this in action in a cut on your arm when straw-colored fluid (plasma) concentrates along the edges of the healing cut. That fluid contains particles that are ‘telling’ the body that there is an injury there and that reconstruction is needed. The body then draws healing nutrients and cells to the area so that healthy new tissue can be formed.

Some of the powerful signaling molecules that platelets make include:

  • Platelet-Derived Growth Factor (PDGF): Responsible for cell growth and division.
  • Vascular Endothelial Growth Factor (VEGF): Responsible for the creation of new blood vessels and capillaries.
  • Transforming Growth Factor (TGF): Controls cell growth and cell differentiation.
  • Epidermal Growth Factor (EGF): Plays a role in cell growth and differentiation.
  • Connective Tissue Growth Factor (CTGF).

Platelet Rich Plasma is made from a fresh sample of your own blood. The sample is specially prepared to separate, concentrate, and stimulate the platelets, which are then injected.

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 regulation CFR 361, allows the use of donated human tissue in medicine without premarket review and approval if the tissue is minimally manipulated, intended for homologous use, and does not claim a cellular signaling function.

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

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

In our clinic, these products are frequently combined with PRP or other allograft therapies (link to allograft page and PRP page) to help support overall regenerative outcomes.

The allogeneic allograft tissue we use is sourced from umbilical cord donations during healthy, live C-section births occurring only in the United States. All products come from an FDA-registered and cGMP-certified laboratory. Donors are screened according to accredited Human Tissue Bank standards and are also tested to rule out infectious diseases.

In both laboratory settings and early clinical studies, these products have shown potential in supporting the regeneration of chronically diseased tissues. These birth tissue products are derived from a purified portion of the umbilical cord known as Wharton’s Jelly. While not intended to provide cellular signaling effects due to FDA regulations, and without claims regarding live cell activity, these products are believed to contain components such as Mesenchymal Stem Cells (MSCs), exosomes (extracellular signaling vesicles), and a polypeptide-enriched matrix (PEM).

MSCs are thought to exert their effects through paracrine signaling—the release of signaling factors that communicate with surrounding cells to support repair and regeneration. Much of this activity is mediated through exosomes, which are small membrane-bound vesicles released by stem cells into the extracellular space. These vesicles carry signaling molecules, proteins, and mRNA that may influence gene expression, support tissue repair, and help modulate inflammation.

Additionally, the polypeptide-enriched matrix (PEM), part of the extracellular structure of Wharton’s Jelly, provides structural support and contains growth factors, peptides, and hyaluronic acid that contribute to the regenerative environment.

When used in this way, these biological materials are thought to:

  • Support cell growth
  • Promote the formation of new blood vessels and capillaries
  • Enhance function and sensitivity of the male sexual organ

References

  1. AH Amol H Trivedi, et al. "The Categorization of Perinatal Derivatives for Orthopedic Applications." Biomedicines, 2024.
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