Lone Peak Biologics: Compliance Statement
Stem cell development has demonstrated substantial development in recent years. It is expected that achievements in this field will contribute to the development of new therapies for serious diseases that were previously fatal. Stem cells as multipotent progenitor cells have the potential to self-renew, but also to differentiate into a widespread diversity of cells that form the tissues and organs of the body. In the human body, a stem cell’s role is as a unit in a restorative system used to replenish tissues for the maintenance of homeostasis. Thanks to this property, stem cells can be utilized directly as therapeutic agents.
HCT/Ps are defined in 21 CFR 1271.3(d) as articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. The US FDA has implemented a risk-based approach to the regulation of HCT/Ps. Under the authority of section 361 of the PHS Act, the FDA established regulations for all HCT/Ps to prevent the introduction, transmission, and spread of communicable diseases. These regulations can be found in 21 CFR Part 1271.
21 CFR 1271
In 21 CFR 1271.10, the regulations identify the criteria for regulation solely under section 361 of the PHS Act and 21 CFR Part 1271. An HCT/P is regulated solely under section 361 of the PHS Act and 21 CFR Part 1271 if it meets all of the following criteria (21 CFR 1271.10(a)):
1) The HCT/P is minimally manipulated;
2) The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent;
3) The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and
i) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
ii) The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
a) Is for autologous use;
b) Is for allogeneic use in a first-degree or second-degree blood relative; or
c) Is for reproductive use.
If an HCT/P does not meet all of the criteria in 21 CFR 1271.10(a), and the establishment that manufactures the HCT/P does not qualify for any of the exceptions in 21 CFR 1271.15, the HCT/P will be regulated as a allograft sample, device, and/or biological product under the Federal Food, Allograft sample and Cosmetic Act (FD&C Act), and/or section 351 of the PHS Act, and applicable regulations, including 21 CFR Part 1271, and pre-market review will be required.
NOTICE: this information is provided pursuant to the requirements mentioned below based on FDA HCT/Ps 21 CFR 1271.3(d) articles, which requires companies doing business to make HCT/Ps products align with applicable federal and state laws and industry standards.