Tissue donation and transplantation

Tissue donation and transplantation is the recovery, processing, storage, and surgical or therapeutic use of banked human tissue allografts, as distinct from solid-organ transplantation.[1] Donatable tissues include the cornea and other ocular tissue, skin, bone and other musculoskeletal tissue (including tendons and ligaments), heart valves, blood vessels, and amniotic membrane.[1][2] Unlike organs, most tissue can be processed, sterilized, and stored for extended periods, so it can be transported and used electively and a single donor can benefit many recipients.[1] In the United States, tissue is recovered and distributed through accredited tissue banks and eye banks and is regulated by the U.S. Food and Drug Administration (FDA) as human cells, tissues, and cellular and tissue-based products (HCT/Ps).[3]

Tissue types and uses

| Tissue | Representative clinical uses | |---|---| | Cornea / ocular | Corneal transplantation (keratoplasty) to restore sight | | Skin | Temporary biologic dressing for severe burns; wound and reconstructive use | | Bone & musculoskeletal | Spinal fusion, joint and trauma reconstruction; tendon/ligament repair | | Heart valves | Valve replacement (cryopreserved homografts), often in children and complex cases | | Blood vessels | Vascular bypass and reconstruction; dialysis access | | Amniotic membrane | Ocular surface and chronic-wound repair |

Corneal transplantation is among the most common and successful tissue transplants; the corneal supply chain is managed by eye banks.[4]

Tissue banking

A tissue bank carries tissue through a regulated sequence: recovery (aseptic recovery from a screened donor, usually within a defined post-mortem window), screening (donor medical-social history and infectious-disease testing), processing (cleaning, cutting, shaping, and often sterilizing the tissue into fresh, frozen, or freeze-dried allografts, frequently in cleanroom conditions), storage, and distribution to surgeons and hospitals.[1][5] In the United States, tissue banks may seek voluntary accreditation from the American Association of Tissue Banks (AATB) (now also styled the Association for Advancing Tissue and Biologics), whose Standards for Tissue Banking is the field benchmark; the 15th edition took effect on January 31, 2025.[5] Eye banks are accredited by the Eye Bank Association of America (EBAA) under its Medical Standards.[4]

Because tissue is storable and processed, much of it flows through both nonprofit banks and for-profit processors, in contrast to organs, which are allocated within hours through the national OPTN system and are not regulated by the FDA's biologics center.[1][3]

FDA regulation (HCT/Ps)

In the United States, human tissue is regulated as HCT/Ps under 21 CFR Parts 1270 and 1271.[3] A central distinction is between products regulated solely under section 361 of the Public Health Service Act, those that are minimally manipulated, intended for homologous use, not combined with another article (with limited exceptions), and without a systemic effect dependent on living cells, which are subject to donor-eligibility, registration, and Current Good Tissue Practice (CGTP) requirements but not premarket approval; and products that fall under section 351, which are regulated as biologics or drugs and require premarket review.[3] CGTP requirements govern donor screening and testing, recovery, processing, storage, labeling, recordkeeping, and adverse-reaction reporting, with the goal of preventing the introduction, transmission, and spread of communicable disease.[3]

Donor screening and safety

Tissue donors undergo a standardized medical-social history interview and infectious-disease testing comparable in rigor to organ-donor screening, including testing for HIV, hepatitis B and C, and other transmissible agents, under FDA donor-eligibility rules and AATB/EBAA standards.[3][5] Donor eligibility is established or overseen by a bank medical director. These safeguards address the small but recognized risk of disease transmission through allografts.[3]

Tissue versus organ donation

Key differences from solid-organ donation:[1][3]

• Storability: tissue can be processed and stored for months or years; organs must be transplanted within hours.
• Reach: one tissue donor can benefit many recipients; organ donation typically benefits a smaller number directly.
• Regulation: tissue is FDA-regulated as HCT/Ps; deceased-donor organs are allocated through the OPTN and are not FDA-regulated.
• Donor eligibility: far more people are eligible to donate tissue than organs, because tissue does not require maintained circulation at the time of recovery.

See also

• Organ donation · Deceased donation
• Organ transplantation · Transplant immunology

References

• American Association of Tissue Banks (AATB). About tissue donation and banking. https://www.aatb.org
• Amniotic membrane. StatPearls. NBK567771. https://www.ncbi.nlm.nih.gov/books/NBK567771/
• U.S. Food and Drug Administration. Tissue and tissue products; HCT/P regulation under 21 CFR 1270/1271; CGTP; 361-vs-351 framework. https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products
• Eye Bank Association of America (EBAA). About us; Medical Standards; keratoplasty supply chain. https://restoresight.org/about-us/
• AATB. Standards for Tissue Banking (15th edition, effective January 31, 2025); accreditation. https://www.aatb.org/standards