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Human Tissue Therapy

About Human Tissue Therapy

Human cells, tissues, and cellular and tissue- based products (HCT/Ps) are products containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion or transfer into a human recipient. The U.S. Food and Drug Administration (FDA) regulates an HCT/P solely through its authority in section 361 of the Public Health Service Act to prevent the transmission of communicable disease — i.e., as a “361 product” rather than as a drug, biologic or medical device — if it meets all the following criteria in 21 CFR 1271.10(a):

• The HCT/P is minimally manipulated.
• The product is intended for homologous use only (meaning that the HCT/P performs the same function(s) in the recipient as in the
donor).
• 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.
• The product does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function (which is satisfied if the product is acellular, meaning that it has no living cells).
HCT/Ps can be obtained from different sources (such as marrow, cord blood, peripheral blood, placental tissue) and have been used in a
variety of therapeutic applications.

Source: McIntyre JA, Jones IA, Danilkovich A, Vangsness CT. The Placenta: Applications in Orthopaedic Sports Medicine. Am J Sports Med. 2018;46(1):234-247; Lim JJ & Koob TJ, Placental Cells and Tissues: The Transformative Rise in Advanced Wound Care, in
Worldwide Wound Healing - Innovation in Natural and Conventional Methods (da Fonseca CJV, ed.) (2016); Fitzpatrick LE & McDevitt T, Cell-derived matrices for tissue engineering and regenerative medicine applications, Biomater Sci. 2015 Jan; 3(1): 12-24.

About tissue allograft

A tissue allograft is an acellular product and does not contain living, viable cells. Placental tissue derived human tissues are classified under FDA 21 CFR 1271 and PHSA Section 361 as a minimally manipulated allograft intended for homologous use.

The tissue allograft is stored at ambient temperature and is a ready-to-use solution that can be poured directly onto the site of treatment. This human tissue is sourced from tissue providers that are accredited by the American Association of Tissue Banks (AATB) and registered with the Food and Drug Administration (FDA) as a processor of human tissue products.

Tissue Allograft characteristics as described in scientific literature:

Protection

Tissue allografts are thought to act as a cover and to offer protection from the surrounding environment.

Extracellular Matrix

An acellular, placental extracellular matrix allograft is a soft connective tissue graft generated by a decellularization process that
preserves the intact extracellular placental matrix.

Source: Leonel, et al., Decellularization of placentas: establishing a protocol, Braz. J. Med. Biol. Res. 2018;51(1):e6382.

Natural

The placenta is a maternal-fetal organ that develops from the fetus and attaches to the uterus during pregnancy. The placenta is
responsible for, among other things, providing the growing fetus with oxygen and nutrients while at the same time removing toxins.

Source: Garnica & WY Chan, The role of the placenta in fetal nutrition and growth, J Am Coll Nutr. 1996 Jun;15(3):206-22.

Donor Testing

All placental tissues are required to be collected aseptically and tested prior to processing, and must be determined to be eligible for transplantation. Applicable donor testing and eligible standards include those prescribed by FDA regulations and those established by the American Association of Tissue Banking (AATB). The processes used have been developed to preserve the tissue characteristics for transplantation.