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 and for homologous use.

Our tissue meets guidelines for FDA exemption under CFR 361, since the donated tissue is designated as a structural support tissue for orthopedic purposes, and is minimally manipulated.

There are two forms of allogeneic products that we use at Hawaii Island Stem Cell therapy and Regenerative Medicine.

 Perinatal Birth Products for Musculoskeletal Medicine

Perinatal birth products have gained significant attention in recent years for their potential benefits in supporting musculoskeletal health. These products, derived from the human placenta and umbilical cord, have been shown to possess unique properties that aid in healing and regeneration.

At Hawaii Island Stem Cell and Regenerative Medicine, the following birth products are available

• Live Mesenchymal Stem Cells (MSC’s) from Umbilical Cord Lineages. This product contains LIVE isolated mesenchymal stem cells that have been verified through numerous testing modalities to ensure proper health and viability. To create this product: Wharton’s Jelly umbilical cord tissue is processed; serology, mycoplasma and endotoxin testing is performed. The MSC’s are isolated using cell-surface marker identification and the outcome is validated using flow cytometry (ACEA Biosciences NovoCyte 3000 machine); Karyotping is performed (Genetic) to ensure cell health and that no chromosomal abnormalities exist. Post thaw viability of these live mesenchymal MSC’s is typically 95%+.

• Live Exosomes (Extracellular Signaling Vesicles) from Umbilical Cord Lineages. Exosomes can modulate immune responses, promote tissue repair, and reduce inflammation through paracrine signaling​​. This product is derived from isolated umbilical derived MSCs with data to support health and lineage of these master cells and the exosome end products.

• Wharton’s Jelly derived polypeptide enriched matrix (PEM). This product is a non-isolated and non-live cell conditioned media leveraging all the cell backgrounds found naturally in Wharton’s Jelly umbilical cord tissue containing growth factors, peptides, HA, exosomes, and stem cell content.

 Key Benefits of Perinatal Birth Products

Perinatal birth products have been found to have several key benefits for musculoskeletal health, including:

• Pain relief: Perinatal birth products have been shown to reduce pain and discomfort associated with musculoskeletal disorders, such as back pain, leg cramps, and pelvic girdle discomfort. 1
• Improved joint function: These products have been found to improve joint function and reduce inflammation, making them a potential treatment for conditions such as osteoarthritis 1
• Enhanced tissue repair: Perinatal birth products contain growth factors and other bioactive molecules that promote tissue repair and regeneration, which can aid in the healing of musculoskeletal injuries 1.
• Immune modulation: These products have been shown to modulate the immune system, reducing inflammation and promoting a healthy immune response. 1

Perinatal birth products offer a promising solution for musculoskeletal health.  Their unique properties make them an attractive option for individuals seeking alternative and complementary treatments for musculoskeletal disorders. Further research is needed to fully understand the benefits and mechanisms of action of perinatal birth products, but the existing evidence suggests that they may be a valuable addition to the treatment options available for musculoskeletal medicine.

 Single Donor Bone Marrow Derived Exosomes

Single donor bone marrow-derived exosomes offer several important benefits, especially in the context of regenerative medicine and treatment of conditions such as osteoarthritis. Here's a breakdown of the key attributes and advantages.

✅ Benefits of Single Donor Bone Marrow-Derived Exosomes 2,3

1. Consistency and Standardization
1. A single donor source allows for batch-to-batch consistency, which is critical in producing a reproducible therapeutic product, amenable to scientific study.
2. Each production batch is proteomically and genetically characterized—every growth factor and RNA molecule can be identified and quantified​.
3. Initial scientific studies in humans show promising results.4
2. High Therapeutic Potency
1. Bone marrow-derived MSCs are known to produce high-quality exosomes rich in anti-inflammatory growth factors, cytokines, and RNA, thought to be similarly matched to the precise signaling of cells needed in musculoskeletal repair.
3. Safety, Efficacy and Low Immunogenicity
1. The product is acellular, meaning no live cells or foreign DNA are introduced—this avoids the risks of tumorigenesis and immune rejection.
2. No reported adverse events and a 12.5-year follow-up study showed no increased cancer risk after bone marrow cell-based therapies​.
3. Bone marrow MSCs have over 63,000 peer-reviewed publications, whereas perinatal MSCs have fewer than 2,000, making BM-derived products better studied and understood.

 *Signature Treatment: Single Donor Bone Marrow Derived Exosomes

• Exosome Derived from Single Donor Bone Marrow Mesenchymal Stem Cell Lineage  >50 Billion Exosomes
• PRP, Platelet Rich Plasma. Approximately 10-12 billion autologous platelets
• BPC 157. Naturally derived Growth and repair “peptide”, 10 mg

Total price:  $5000

 *Signature Treatment: Umbilical Cord Derived Whartons Jelly, 2 cc.

• Umbilical Cord Derived Whartons Jelly extract containing, 7 Billion Exosomes, 3 Million Mesenchymal Stem Cells, plus Polypeptide Enhanced Extracellular Matrix 2 ml
• BPC 157. Naturally derived Growth and repair “peptide”, 10 mg
• PRP, Platelet Rich Plasma. Approximately 10-12 billion autologous platelets

Total Price: $4250

 *Signature Treatment: Umbilical Cord Derived Whartons Jelly, 1 cc.

• Umbilical Cord Derived Whartons Jelly extract containing, 3.5 Billion Exosomes, 1.5 Million Mesenchymal Stem Cells, plus Polypeptide Enhanced Extracellular Matrix 1 ml
• BPC 157. Naturally derived Growth and repair “peptide”, 10 mg
• PRP, Platelet Rich Plasma. Approximately 10-12 billion autologous platelets

Total Price: $2750 

 References

1. AH Amol H Trivedi, et al. "The Categorization of Perinatal Derivatives for Orthopedic Applications." Biomedicines, 2024.
2. Pettine KA, Dordevic M (2019) The Biologic Treatment of Osteoarthritis with Mesenchymal Stem Cell Exosomes: The Future is Now. J Stem Cell Res Dev Ther: S1001.
3. 3.East J, Dordevic M (2020) The Safety Profile of a Bone Marrow-Derived Mesenchymal Stem Cell Extracellular Vesicle Isolate Product. J Stem Cell Res Dev Ther 6: 026.
4. 4. East J, Dordevic M. (2021) Pilot Safety Study of an Extracellular Vesicle Isolate Product for Treatment of Osteoarthritis in Combat-Related Injuries: One Year Follow Up. J Stem Cell Res. 2(2):1-10.