By: Susan St. John
Many practitioners or establishments looking to enhance their practice and offer more treatment options to their patients are considering HCT/P and Stem Cell Therapy in addition to other traditional treatment options. However, before embarking on offering HCT/P or STEM Cell Therapy, a practitioner or establishment needs to carefully consider protocol and procedure for offering HCT/Ps or STEM Cell Therapy.
The FDA defines HCT/Ps as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion or transfer into a human recipient.” 21 CFR 1271.3(d). HCT/Ps include bone, ligament, skin, dura mater, heart valve, cornea, hematopoietic stem/progenitor cells derived from peripheral and cord blood, manipulated autologous chondrocytes, epithelial cells on a synthetic matrix, and semen or other reproductive tissue.read more