Clinical Information
Gen. Code and Des.
44254 cult skin subst,human-bovine TOPICAL DISK
GCN and Des.
92492 cult skin subst,human-bovine TOPICAL DISK
Strength
Dose Form
DISK
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
94000000 DEVICES
Active Ingredients
7999 cultured skin substitute,human and bovine
Inactive Ingredients
What is Apligraf?
Apligraf is living cell based product for chronic venous leg ulcers and diabetic foot ulcers. Apligraf is supplied as living, bi-layered skin substitute. Like human skin, Apligraf consists of living cells and structural proteins. The lower dermal layer combines bovine type collagen and human fibroblasts (dermal cells), which produce additional matrix proteins. The upper epidermal layer is formed by promoting human keratinocytes (epidermal cells) first to multiply and then to differentiate to replicate the architecture of the human epidermis. Unlike human skin, Apligraf does not contain melanocytes, Langerhans" cells, macrophages, and lymphocytes, or other structures such as blood vessels, hair follicles or sweat glands. Apligraf is supplied as circular disc approximately 75 mm in diameter and 0.75 mm thick. Apligraf is the only living, bi-layered cell based product FDA approved to heal both Diabetic Foot Ulcers and Venous Leg Ulcers. EVICE DESCRIPTION FDA has approved Apligraf as Class III medical device via premarket approval [PMA]. In addition, Apligraf meets applicable requirements for Human cell, tissue, and cellular and tissue-based product [HCT/P] in accordance with 21 CFR Parts 1270 and 1271. Apligraf is supplied as living, bi-layered skin substitute: the epidermal layer is formed by human keratinocytes and has well-differentiated stratum corneum; the dermal layer is composed of human fibroblasts in bovine Type collagen lattice. While matrix proteins and cytokines found in human skin are present in Apligraf, Apligraf does not contain Langerhans cells, melanocytes, macrophages, lymphocytes, blood vessels or hair follicles. In 10 patient venous leg ulcer study to determine the longevity of Apligraf cells, of patients evaluated at weeks demonstrated Apligraf DNA. Neither of these patients showed Apligraf DNA at weeks. Cells used in the manufacture of Apligraf are processed under aseptic conditions. The cells are originally derived from donated human neonatal male foreskin tissue. The foreskin donor?s mother is tested and found negative for human viruses, including antibodies to human immunodeficiency virus types and (HIV-1 and HIV-2), human immunodeficiency virus type (HIV-1), human T-lymphotropic virus types and (HTLV-1 and HTLV-2), hepatitis virus (HAV), hepatitis virus (HBV), hepatitis surface antigen (HbsAg), hepatitis virus (HCV), west nile virus (WNV), epstein barr virus (EBV), cytomegalovirus (CMV), and syphilis. The fibroblast and keratinocyte cell banks which are the source of the cells from which Apligraf is derived are tested for human and animal viruses, retroviruses, bacteria, fungi, yeast, mycoplasma, karyology, isoenzymes, and tumorigenicity. The final product is tested for morphology, cell viability, epidermal coverage, sterility, mycoplasma, and physical container integrity. Product manufacture also includes reagents derived from animal materials including bovine pituitary extract. All animal derived reagents are tested for viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma before use. Bovine materials are sourced to minimize bovine spongiform encephalopathy (BSE). 2. INTENDED USE INDICATIONS Apligraf is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than month duration and which have not adequately responded to conventional ulcer therapy. Apligraf is also indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure