FACE + HAND TRANSPLANTS : NEW NAME, NEW REGULATORY NICHE

Clinical transplantation has moved forward in leaps and bounds, surpassing the speed of the U.S.  government in addressing regulatory standards for new transplant types. This is neither an irrelevant nor a minor issue and has just been definitively addressed by the Final Rule published in the July 3, 2013 Federal Register. The National Organ Transplant Act (NOTA) originally enacted in 1984 had defined a specific list of transplant organs based on all of the transplant types that were performed in that era. The Organ Procurement and Transplantation Network (OPTN) and United Network for Organ Sharing (UNOS) oversee and regulate those types of organ transplantation with a fully developed set of bylaws for member institutions and policies that determine how transplants are undertaken. These transplants currently include:

ORGAN TRANSPLANTS
Kidney
Liver
Heart
Lung
Pancreas
Intestine (any part of the intestinal tract)

In contrast, human cells or tissue for transplantation are under the regulatory jurisdiction of the Food and Drug Administration (FDA) under Section 361 of the Public Health Service Act and 21 CFR parts 1270 and 1271.  Examples (not inclusive) of Cell and Tissue “Implants/Transplants” include:

CELL + TISSUE “IMPLANTS/TRANSPLANTS” 
Bone
Skin
Cornea
Ligaments
Stem cells
Peripheral blood
Cord blood
Oocytes
Semen

Face, hand, larynx, and abdominal wall transplants are all examples of transplants that did not clearly fit into either of the two pre-existing categories. Agreeing with advocates within the transplant community, the Secretary of Health and Human Services issued this Final Rule that has formally created a new category of Vascularized Composite Allografts (VCA), (allograft = transplant between non-identical members of the same species) that is defined based on functions below (ischemia is a period of interrupted blood, see below):

VASCULARIZED COMPOSITE ALLOGRAFTS 

  1. Vascularized – requires blood flow by surgical connection
  2. Contains multiple tissue types
  3. Recovered from a human donor as an anatomical/structural unit
  4. Transplanted into a human recipient as an anatomical/structural unit
  5. Minimally manipulated or processed (but may be cut or shaped)
  6. For homologous use (i.e., to be used for the same purpose in the recipient as it was in the donor)
  7. Subject to ischemia and therefore stored only temporarily
  8. Subject to allograft rejection and generally requiring immunosuppression

The Final Rule also clearly stipulates that VCA transplants fall under the jurisdiction of the OPTN/UNOS, not the FDA. Major implications of this definition are that VCA transplants may only be performed at OPTN member institutions in good standing. New policies specifically applicable to VCA transplants clearly need to be developed by the OPTN/UNOS.

Because of the unique issues pertaining to donor consent for these specific transplant types, wherein donor identification may be retained (e.g., fingerprints and facial identifiers), the Final Rule implies that donor specific consent should be undertaken on a case-by-case basis. This is the current ad hoc practice. But new issues of allocation will arise if the number of transplants begins to grow substantially. For example, there is no other transplant type in which skin color may be relevant!

Overall, a new field of medicine is currently developing at a very rapid pace. This one step is an important one. It will be challenging and exciting as others are made. Stay tuned.

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