References
We are proud to partner with a tissue bank/lab providing us with the highest quality human tissue allografts available in the US. Our goal is to address the root causes of injury/crisis, rather than masking the pain. This tissue bank is a first class, state of the art facility, that spares no expense when it comes to the technology in producing quality HCT/P products. Our HCT/P allographs provide a non-addictive/non-invasive option for patients. Our lab produces one of the only Wharton’s Jelly allografts to be recognized as a 361 HCTP by any government body and it has been working with the FDA’s discretionary committee since beginning 361 HCT/P’s oversight. The lab is an FDA registered and inspected tissue bank which follows all good tissue practice guidelines per FDA 21 CFR 1271 of the PHS act. The lab is a “Registered Tissue Establishment” via HUMAN CELL AND TISSUE ESTABLISHMENT REGISTRATION (HCTERS) as well as CGMP, CGTP FDA certificates.
A short explanation of acquiring the Umbilical Cords and Processing
The tissue bank accepts donated Umbilical Cords of post C-Section births. There is ABSOLUTELY NO Pre-Birth or Aborted Fetal Tissue as it is Illegal in the U.S.. The Lab then tests for any viruses or pathology of the Umbilical Cord to give it a clean bill-of-health. The tissue bank then dissects the Wharton’s Jelly from said umbilical cord which is rich in trophic factors, MSCS, cytokines, ido, etc. Other processing takes place to make it useable as a 361 product. When injected for homologous use per the HCTP FDA guidelines, these youthful cells and tissue products promote or signal repair, reconstruction, supplementation, cushioning, etc to the injured or damaged joint and/or tissue in crisis.
References from the FDA
HCT/Ps may perform multiple functions and the FDA acknowledges that structural tissues contain cells. The FDA also acknowledges that some manufacturers assert that an HCT/P has both a structural and cellular/nonstructural function. However, under the regulations, HCT/Ps are
considered either structural tissues or cells/nonstructural tissues (see section III.B) Click Here
Wharton’s jelly is a structural connective tissue, and while this tissue contains cells, none of its native cell populations contribute to its primary structural function when processed to comply with 21 CFR 1271.10(a) of the PHS Act.
Journal References/Excerpts
The mesenchymal stem cell (MSC) is being broadly studied in clinical trials. Contrary to the early paradigm of cell replacement and differentiation as a therapeutic mechanism of action, evidence is mounting that the secretions of the cells are responsible for their therapeutic effects. These secretions include molecules and extracellular vesicles that have both local and distant effects. This review summarizes the up- and down-regulation of MSC anti-inflammatory, immune modulating, anti-tumor, and regenerative secretions resulting from different stimuli including: a) hypoxia, which increases the production of growth factors and anti-inflammatory molecules; b) pro-inflammatory stimuli that induce the secretion of immune modulating and anti-inflammatory factors; and c) 3 dimensional growth which up regulates the production of anti-cancer factors and anti-inflammatory molecules compared to monolayer culture.
Osteoarthritis (OA) is a degenerative disease of the connective tissue and progresses with age in the older population or develops in young athletes following sports-related injury. The articular cartilage is especially vulnerable to damage and has poor potential for regeneration because of the absence of vasculature within the tissue………… Since the tissue is composed primarily of chondrocytes distributed in a specialized extracellular matrix bed, bone marrow stromal cells (BMSCs), also known as bone marrow-derived ‘mesenchymal stem cells’ or ‘mesenchymal stromal cells’, with inherent chondrogenic differentiation potential appear to be ideally suited for therapeutic use in cartilage regeneration……….. Moreover, by secreting various bioactive soluble factors, BMSCs can protect the cartilage from further tissue destruction and facilitate regeneration of the remaining progenitor cells in situ. This review broadly describes the advances made during the last several years in BMSCs and their therapeutic potential for repairing cartilage damage in OA.
