2.
In the present study, patients experiencing heel pain caused by chronic plantar fasciosis and Achilles tendinosis and who were unresponsive to standard therapies for a minimum of 6 months were treated with PalinGen SportFLOW (Amnio Technology, llc. Phoenix, AZ) to promote tissue repair and regeneration. The PalinGen SportFLOW allograft was generated from human amniotic membrane and amniotic fluid (hAM-AF), harvested from females undergoing elective caesarian section. PalinGen SportFlow is a human allograft and is processed and packaged at an FDA registered tissue bank accredited by the American Association of Tissue Banks (AATB). PalinGen SportFLOW is regulated by the FDA under Title 21 Part 1271 Section 361 of the Public Health Service Act. Tissues were tested extensively to ensure the absence of communicable diseases and other abnormalities. After testing, the tissues were aseptically processed and cryopreserved to preserve cell viability. Cryopreservation of the hAM-AF yielded a multifactorial tissue matrix contain- ing viable pluripotent mesenchymal stem cells, fibroblasts, keratinocytes, epithelial cells, cytokines, proteins, growth factors, and multipotent cells, all required for fetal growth and development and able to stimulate tissue repair and regeneration. In this study, allografts were used to create a microenvironment suitable for regeneration of tendons and fascia that had become chronically thickened due to abnormal function and healing. Allograft was also used as a potent anti-inflammatory and to create the appropriate conditions in which to drive poorly formed tendons and fascia to a normal state.
The PalinGen SportsFLOW allograft most important components are a wide spectrum of growth factor proteins, that are, VEGF, TGF-beta1, EGF, PDGF-AA, PDGF-BB,
FGFb, extracellular matrix (cryofractured amnion mem- brane) and amniotic fluid derived cells.
Amnion donors were subject to a thorough prescreen- ing process performed by the Medical Director. Eligibility was confirmed through behavioral risk assessment, medical history, hematology, and communicable disease testing. Pro- curement of the amnion tissues was done with an aseptic recovery technique during cesarean section, using standard sterile techniques. Procurement of hAM-AF does not require fetal death, and its recovery was performed with maternal consent during an elective caesarian section live birth.