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Shire Regenerative Medicine Initiates Phase 3 Study Of ABH001 For Patients With Epidermolysis Bullosa

ABH001 is comprised of allogenic neonatal dermal fibroblasts seeded on a poly(glycolide-co-L-lactide) scaffold, and is currently approved and marketed in the United States as a Class III medical device under the trade name Dermagraft ® for the treatment of diabetic foot ulcers.

About Epidermolysis Bullosa (EB)

Epidermolysis Bullosa is a family of genetic skin fragility disorders, primarily clinically characterized by blistering of the skin in response to friction or minor trauma. Although genetically and phenotypically heterogeneous, the common factor in all EB patients is the near constant presence of skin erosions and wounds. Severe forms of EB cause patients to live with constant pain and scarring, and may be fatal.

About ABH001

ABH001 is a tissue-engineered, human fibroblast-derived dermal substitute generated by culturing human neonatal dermal fibroblasts onto a bioabsorbable polyglactin (PGLLA) mesh scaffold. The fibroblasts, which are grown onto the PGLLA mesh, secrete dermal collagen, other extracellular matrix proteins, growth factors, and cytokines, creating a three-dimensional human tissue containing metabolically active living cells. The final product consists of a well-developed dermal matrix and evenly dispersed neonatal dermal fibroblasts.

About Dermagraft

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 adequate blood supply to the involved foot. Dermagraft is contraindicated for use in ulcers that have signs of clinical infection or in ulcers with sinus tracts. Dermagraft is contraindicated in patients with known hypersensitivity to bovine products, as it may contain trace amounts of bovine proteins from the manufacturing medium and storage solution.

NOTES TO EDITORS

Shire enables people with life-altering conditions to lead better lives.

Through our deep understanding of patients' needs, we develop and provide healthcare in the areas of:
  • Behavioral Health and Gastro Intestinal conditions
  • Rare Diseases
  • Regenerative Medicine

as well as other symptomatic conditions treated by specialist physicians.

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