Last updated on 8/26/18 | First published on 9/18/17 | Literature review current through Mar. 2024
[cite]
(2018).
"Allogeneic matrix". In
(Eds.)
, WoundReference.
Available from: https://woundreference.com/app/topic?id=ctp-allogeneic-matrix. Retrieved on 4/20/24.
OVERVIEW
Allogeneic Matrices are usually derived from human neonatal fibroblasts of the foreskin that may contain metabolically active or regenerative components primarily used for soft tissue support, though some have been approved for the treatment of full-thickness skin and soft tissue loss. Most are biodegradable and disappear after 3-4 weeks implantation. [1] This category also includes cellular and/or tissue products (also known as skin substitutes) derived from amnion, chorion, placenta or umbilical cord that have not been decellularized.
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REFERENCES
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CGS Administrators, LLC et al. LCD: Wound Application of Cellular and/or Tissue Based Products (CTPs), Lower Extremities (L36690) . 2022;.
Topic 18 Version 1.0
SUBTOPICS
CLINICAL
FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/Ps. Among other criteria, HCT/Ps are required to be mini
AlloWrap DS is a human amniotic membrane designed to provide a biologic barrier following surgical repair. See clinical, coding and reimbursement information
CLINICALIndicationsIntended for homologous use as a wound covering.FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of
CLINICALIndicationsFor homologous use as an acute or chronic wound covering
FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of com
CLINICALIndicationsAMNIOEXCEL® is intended for use as a wound covering. This product is an allograft tissue intended for homologous use for the repair, reconstruction and replacement of skin at the direction of a physician.
FDARegulated under PHS 361
CLINICALIndications Diabetic Ulcers Pressure Ulcers Venous Stasis Ulcers Burns
BioDDryFlex® is a membrane allograft derived from the human placental tissues for use as a tissue barrier. See clinical, coding and reimbursement information.
BioDFence G3 is a multilayer amnion and chorion allograft that covers and protects underlying tissues. See clinical, coding and reimbursement information.
Cygnus is an allogeneic matrix, traditional single layer amnion for topical wounds/burns. See clinical, coding and reimbursement information.
Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure.Dermagraft should be used in conjunction with standard wound care regimens and in patients that have ad
CLINICALIndicationsPartial and full thickness wounds. Diabetic UlcersPressure ulcersTrauma Wounds (abrasions, lacerations, second degree burns, skin tears)Venous UlcersDrainage WoundsChronic Vascular Ulcers Surgical (donor sites/grafts post mohs surgery, post laser surgery, podiatr
CLINICALIndicationsProvides a connective tissue matrix to replace or supplement damaged or inadequate integumental tissue
FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue practice, and other procedures to prevent the
CLINICALIndicationsIntended for homologous use in acute and chronic wound care.FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue practice, and other procedures to pre
Excellagen is a flowable allogeneic matrix - a pharmaceutically formulated fibrillar Type I bovine collagen gel for wound care management. See clinical, coding and reimbursement information
E-Z Derm is an allogeneic matrix (porcine xenograft) for wound coverage. See clinical, coding and reimbursement information
CLINICALIndicationsSoft tissue defect fillerSoft tissue traumaTendinitisTendinosisChronic woundsLocalized inflammationJoint painStrains, partial tears (muscles, ligaments, tendons)
FlowerFlo™ Placental Tissue Matrix Allograft is an allogeneic matrix intended to replace or supplement damaged or inadequate integumental tissue.
FlowerPatch™ Amniotic Membrane is a dehydrated amniotic membrane allograft intended to be used as a wound covering. See clinical, coding and reimbursement information.
Grafix is a cryopreserved placental membrane comprised of an extracellular matrix (ECM) rich in collagen, growth factors, fibroblasts, mesenchymal stem cells (MSCs), and epithelial cells native to the tissue
Grafix is a cryopreserved placental membrane, made of human amniotic membrane used for wound coverage
CLINICAL IndicationsNEOX100 can be used as a surgical covering, wrap or barrier.
FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spr
CLINICALIndicationsNEOX 1k is a thicker cryopreserved amniotic membrane tissue that is intended for use when durable tensile strength is indicated.NEOX 1k can be used for tectonic support as a surgical covering, wrap or barrier.
FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishmen
CLINICALIndicationsAdhesion barrier, wound covering, acts as an adjunct to soft tissue healingDirect application, wrapping or suturing around tendons, on-lay graft
FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, cur
PalinGen Membrane and Hydromembrane are human allografts processed from healthy placental tissue for wound coverage. See clinical, coding and reimbursement information.
Revita is an intact human placental membrane allograft. See clinical, coding and reimbursement information.
CLINICALIndicationsStravix can be used as a surgical covering or wrap for several procedures, including but not limited to:Tendon RepairAchilles Tendon RuptureBunionectomyHallux Rigidus CorrectionFoot AmputationsFibromatosisArthrodesis
Talymed is an advanced sterile wound matrix composed of shortened fibers of poly-N-acetyl glucosamine (pGlcNAc), isolated from microalgae. See clinical, coding and reimbursement information.
CLINICALIndicationsmembrane wrap, cover or patch for soft tissuesprovides a physical covering to protect tendons and nerves at the surgical site FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue pr
RELATED TOPICS
Human Skin Allografts are bioengineered from human skin components and human tissue which have had intact cells removed or treated to avoid immunologic rejection.
Composite Matrices are a type of cellular and/or tissue products derived from human keratinocytes and fibroblasts supported by a scaffold of synthetic mesh or xenogeneic collagen.
Skin Substitute:Duration of ulcer - approximately 89 weeksWound free of infection, osteomyelitis, surrounding cellulitis, tunnels/tracts, necrotic tissue - yesInitial Application/Reapplication - 3rd applicationSkin substitute used - Grafix PrimeMethod of fixation - Mepitel, steristripsLot # - A160300Unit # - 16003Part # - PS60013Expiration date - 6/14/18
