Dermagraft® is a cryopreserved human fibroblast-derived dermal substitute; it is composed of fibroblasts, extracellular matrix, and a bioresorbable scaffold.
Dermagraft is manufactured from human fibroblast cells derived from newborn foreskin tissue. During the manufacturing process, the human fibroblasts are seeded onto a bioabsorbable polyglactin mesh scaffold. The fibroblasts proliferate to fill the interstices of this scaffold and secrete human dermal collagen, matrix proteins, growth factors, and cytokines to create a three-dimensional human dermal substitute containing metabolically active, living cells. Dermagraft does not contain macrophages, lymphocytes, blood vessels, or hair follicles.
Dermagraft is supplied frozen in a clear bag containing one piece of approximately 2” x 3” for a single-use application.
Dermagraft Overview
- Description - Human fibroblast-derived dermal substitute
- Composition - Composed of human fibroblasts, extracellular matrix, and bioabsorbable scaffold; does not contain macrophages, lymphocytes, blood vessels, or hair follicles
- Cultured In Vitro
- Mode of Action - Re-epithelialization — assists in the restoration of the dermal bed, allowing wounds to heal (when implanted into adequately prepared diabetic foot ulcers)
- Product Number - 11045
Dermagraft Indication
Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than 6 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 who have adequate blood supply to the involved foot.
Contraindications:
- 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
Dermagraft Safety
Manufacturing Safety
Dermagraft is cryopreserved to allow long-term maintenance of tissue integrity and cellular viability. Benefits of Cryopreservation include:
- Allows for safety testing prior to shipping and application
- Provides longer shelf life-long-term storage (up to 6 months) when stored at -75°C ± 10°C
Each lot of Dermagraft is tested and results are known before it is released.
Final product microbiological testing:
- Final product sterility
- Endotoxin (cryopreservation solution)
- Endotoxin (tissue)
- Mycoplasma by DNA fluorochrome stain
- Direct cultivation of mycoplasma (28 day test by approved 3rd party laboratory)
Adverse Events1,2
The most common adverse effects occurring in the Dermagraft (n=163) and control (n=151) groups included all randomized patients, respectively, were infection at study wound (10.4% vs 17.9%), infection not at study wound all randomized patients (10.4% vs 9.3%), accidental injury (10.4% vs 11.9%), and skin dysfunction/blister (9.8% vs 13.2%). The overall incidence of adverse events was approximately the same for both the Dermagraft and control groups. No adverse laboratory findings were associated with the use of Dermagraft and no adverse device effects were reported in the study. The number of patients who developed study ulcer-related adverse events (ie, local wound infection, osteomyelitis, cellulitis) was significantly lower in the Dermagraft-treated group (19%) as compared with the control group (32.5%, P=0.007).
Patients Experiencing Infection, Osteomyelitis, or Cellulitis Involving the Study Ulcer1,2
| Event | Dermagraft (n=163) | Control (n=151) |
|---|---|---|
| Infection | 17 (10.4%)* | 27 (17.9%) |
| Osteomyelitis | 14 (8.6%) | 13 (8.6%) |
| Cellulitis | 12 (7.4%) | 14 (9.3%) |
| Overall | 31 (19.0%)† | 49 (32.5%) |
*P=0.073 vs control; †P=0.007 vs control.
For full safety information, please reference the Dermagraft Directions for Use.
Advanced BioHealing, Inc, (ABH) is a leader in regenerative medicine focused on the development and marketing of cell-based and tissue-engineered products. For more information about ABH and Dermagraft, visit www.ABH.com, or click here for other inquiries.
References
- Marston WA, Hanft J, Norwood P, Pollak R; Dermagraft Diabetic Foot Ulcer Study Group. The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial. Diabetes Care. 2003;26(6):1701-1705.
- Dermagraft [Directions for Use]. La Jolla, CA: Advanced BioHealing; 2007.