Table 7.
HCT/P products approved for burns.
| Banked Human tissue: allograft (amniotic membrane) | Allograft intended for use as a biological membrane covering for PT and FT acute wounds such as burn | |
|---|---|---|
| Treatment type | Product, company | Composition |
| Cellular | Affinity™, Organogenesis, Inc. | Fresh AM with viable cells stored hypothermically |
| Grafix®, Osiris Therapeutics, Inc. | Cryopreserved sheets stored at −75 to −85°C for 2 years | |
| Acellular | ActaShield™ Amniotic Barrier Membrane, Wright Medical Technology | Decellularized, dehydrated sheets stored RT for 5 years |
| AmnioBand®, Musculoskeletal Transplant Foundation | Dehydrated sheets stored RT for 3 years | |
| AmnioFix® and EpiFix®, MiMedx Group | Dehydrated sheets stored RT for 5 years | |
| Amnioshield®, Alphatec Spine, Inc. | Dehydrated sheets stored RT for 5 years | |
| Biovance®, Alliqua Biomedical | Decellularized, dehydrated sheets stored RT | |
| Dermavest™, Aedicell | Decellularized AM ECM Particulate pressed into a pad that can be stored at RT for 3 years | |
| Clarix™, and Neox®, Amniox® Medical | Cryopreserved umbilical cord and AM sheets available cryopreserved and fully hydrated at RT for 2 years | |
| NuShield™, Organogenesis, Inc. | Sterilized, dehydrated sheets stored at RT | |
| Revitalon™, Medline Industries | Aseptically processed sheets stored at RT | |
| Banked human tissue: allograft (human skin) | Allograft intended for use as a biological membrane covering for PT and FT acute wounds such as burn; or for repair or replacement of damaged or inadequate integument tissue or for other homologous uses of human integument | |
| Cellular | Burn Care Allografts, Allosource | Bilayered allograft consisting of viable cells in epidermis and dermis available in fresh and cryopreserved solid and meshed sheets |
| ReadiGraft®, LifeNet Health | Same as above; only available in cryopreserved sheets | |
| Theraskin®, SolSys™ Medical | Same as above; only available in cryopreserved sheets | |
| Acellular | AlloDerm® Regenerative Tissue Matrix, LifeCell Corp. | Acellular, FD dermal sheets stored at RT |
| AlloPatch®, Musculoskeletal Transplant Foundation | Acellular dermal hydrated sheets stored at RT for 3 years | |
| DermaCell®, LifeNet Health | Decellularized dermal solid and meshed hydrated sheets stored at RT | |
| DermaPure™, Tissue Regenix Wound Care | Decellularized dermal sheets stored at RT | |
| DermaMatrix™, Synthes | FD non-cross-linked dermal sheets stored at RT | |
| FlexHD®, Ethicon | Acellular hydrated non-sterilized dermal sheets at RT | |
| GammaGraft™, Promethean LifeSciences, Inc. | γ-Irradiated skin | |
| GraftJacket™ Regenerative Tissue Matrix, Wright Medical Technology | Acellular, FD dermal sheets | |
| Maxxeus™ Skin, Community Tissue Services | Cryopreserved low dose terminally sterilized skin | |
FD, Freeze Dried; FT, Full-Thickness; PT, Partial-Thickness; RT, Room Temperature.