As of November 24, 2004, the FDA (Food and Drug Administration*1) officially announced "21 CFR Parts 16, 1270, and 1271"(*2), - regulations (*3)on handling of human cell/tissue and cellular/tissue-based products, and it enacted them on May 25 in 2005.
In this regulation, human cells/tissue and cellular/tissue-based products are referred to as HCT/P, and highly safe practices for handling human cells/ tissue are stipulated as described below. The way of handling cells and tissue in CAL tissue augmentation procedures completely satisfies all these criteria.
If a HCT/P satisfies all the following standards, it will be categorized as a product with a certain level of safety(*4).
- It shall be minimally manipulated.
E "Minimally manipulated" is defined as follows:- In the case of structural tissue, the essential nature of the tissue in connection with its usefulness, such as rebuilding, restoration or replacement of tissue, shall not be changed.
- In the case of non-structural tissue, critical biological characters of the tissue shall not be altered.
- The purpose of the manipulation shall be to use an organ offered from a donor as the same organ and as the same function in the recipient body.
- It shall not be mixed with other products (except water, disinfectants, and preservatives).
- Others
- It shall not be given to the entire body of a patient, and shall not depend on metabolic function of cells, OR,
- It may be given to the entire body of a patient, and depend on metabolic function of cells, but it shall be conducted as a self-transplantation, and shall not be used for relatives in the first or second degree, nor for reproduction purposes.
*1U.S. Food and Drug Administration. FDA is an administrative body under the umbrella of the HHS (Department of Health and Human Service - equivalent to MHLW in Japan), which controls and grants permissions for manufacturing and sales of food, medical products, medical equipment and cosmetics. The FDA's primary mission is to protect the health and welfare of people by guaranteeing the safety and efficacy of medical products for human beings, animals, biomedical products, medical equipment, food, cosmetics, and radioactive products.
*2Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement; Final Rule
*321 CFR : Code of Federal Regulations-Title 21 : The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government.. Title 21 of the CFR is reserved for rules of the Food and Drug Administration. Each title (or volume) of the CFR is revised once each calendar year. A revised Title 21 is issued on approximately April 1st of each year.
*4An HCT/P is regulated solely under section 361 of the PHS Act and the regulations in this part(=in 21 CFR Part 1271) if it meets all of the following criteria
In Japan, however, in Appendix 2 of the MHLW Notification No.1314 (December 26 in 2000) - guidelines for ensuring the quality and safety of human cellular and tissue-based medical products (hereafter referred to as "Guidelines"), the following is stipulated:
In accordance with the Guideline, MHLW concluded that CAL tissue augmentation procedures "do not come under the definition of cell processing". In other words, CAL tissue augmentation procedures have been proven to be of little concern in connection with human cellular/tissue-based medical products.
"Processing cells/tissue" is a method of treatment of a disease or a restoration/rebuilding of tissue, and means artificial multiplication of cells and tissue, chemical processing of cells and tissue for the purpose of reinvigorating them, alteration of their biological characters, gene-engineering modification, creation of hybrid types with non-cellular/non-tissue-based components, and creation of capsules. Tissue isolation, tissue slicing, cell isolation, single isolation of specific cells, antibiotic treatment, cleansing, radiation sterilization (gamma radiation), freezing, and defrosting are not considered as "processing".
