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SkinTE
SkinTE is a living, autologous skin tissue engineered from a patient's own cells to regenerate functional skin for wound healing and burn treatment.
SkinTE is a living, autologous skin tissue engineered from a patient's own cells to regenerate functional skin for wound healing and burn treatment. Used for Acute thermal burns, Chronic wounds.
At a glance
| Generic name | SkinTE |
|---|---|
| Also known as | Autologous Heterogeneous Skin Construct |
| Sponsor | PolarityTE |
| Drug class | Autologous cell therapy / Tissue-engineered product |
| Modality | Biologic |
| Therapeutic area | Dermatology / Wound Care |
| Phase | FDA-approved |
Mechanism of action
SkinTE uses a patient's own skin cells (keratinocytes and fibroblasts) to create a living tissue construct that mimics natural skin architecture. The engineered tissue is applied directly to wounds or burns, where it integrates with the patient's remaining tissue and promotes healing through cellular regeneration and restoration of skin barrier function.
Approved indications
- Acute thermal burns
- Chronic wounds
Common side effects
- Infection at application site
- Graft failure or poor integration
- Scarring
Key clinical trials
- Expanded Access Program Evaluating SkinTE in the Treatment of Wagner 1 Diabetic Foot Ulcers
- SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II) (PHASE3)
- Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® in the Treatment of Wagner 2 DFUs (PHASE3)
- SkinTE® in the Treatment of Venous Leg Wounds (NA)
- SkinTE™ in the Treatment of Diabetic Foot Wounds (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |