Autologous stem cells
"Autologous" (pronounced aw-TAH-luh-guhs) means a transplant or transfusion of biological material that is taken from the same person.
The FDA asserts authority to regulate and prohibit the transplant of biological material to the same patient from which it was taken. It asserted this authority by staggering implementation of its regulation: its first rule was effective April 4, 2001, which covered transplantation to another person different from the source of the biological material, and then nearly two years later, on January 21, 2003, was the effective date of the expansion in definition to include transplantation to the same patient.
Autologous stem cells have been found to help treat several illnesses:
- they "have reversed the neurological dysfunction of early-stage multiple sclerosis patients by transplanting their own immune stem cells into their bodies and thereby 'resetting' their immune systems."
- Autologous use means the implantation, transplantation, infusion, or transfer of human cells or tissue back into the individual from whom the cells or tissue were recovered.
It defines, for the purpose of regulation, human cells and similar material as including autologous use:
- (d) Human cells, tissues, or cellular or tissue-based products (HCT/Ps) means articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. Examples of HCT/Ps include, but are not limited to, 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. The following articles are not considered HCT/Ps:
- (1) Vascularized human organs for transplantation;
- (2) Whole blood or blood components or blood derivative products subject to listing under parts 607 and 207 of this chapter, respectively;
- (3) Secreted or extracted human products, such as milk, collagen, and cell factors; except that semen is considered an HCT/P;
- (4) Minimally manipulated bone marrow for homologous use and not combined with another article (except for water, crystalloids, or a sterilizing, preserving, or storage agent, if the addition of the agent does not raise new clinical safety concerns with respect to the bone marrow);
- (5) Ancillary products used in the manufacture of HCT/P;
- (6) Cells, tissues, and organs derived from animals other than humans; and
- (7) In vitro diagnostic products as defined in § 809.3(a) of this chapter.
- (8) Blood vessels recovered with an organ, as defined in 42 CFR 121.2, that are intended for use in organ transplantation and labeled "For use in organ transplantation only."
The FDA defines "manufacture" broadly also:
- (e) Manufacture means, but is not limited to, any or all steps in the recovery, processing, storage, labeling, packaging, or distribution of any human cell or tissue, and the screening or testing of the cell or tissue donor.
- See 66 FR 5447.
- 21 CFR 1271.3