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Cultured autologous keratinocytes
Cultured autologous keratinocytes is a Cell therapy; autologous cellular product Biologic drug developed by Association of Dutch Burn Centres. It is currently in Phase 3 development for Severe thermal burns requiring skin grafting. Also known as: Cultured keratinocytes.
Cultured autologous keratinocytes are patient-derived skin cells grown in vitro and applied topically to promote wound healing and skin regeneration in severe burn injuries.
Cultured autologous keratinocytes are patient-derived skin cells grown in vitro and applied topically to promote wound healing and skin regeneration in severe burn injuries. Used for Severe thermal burns requiring skin grafting.
At a glance
| Generic name | Cultured autologous keratinocytes |
|---|---|
| Also known as | Cultured keratinocytes |
| Sponsor | Association of Dutch Burn Centres |
| Drug class | Cell therapy; autologous cellular product |
| Modality | Biologic |
| Therapeutic area | Dermatology; Wound Care; Burn Treatment |
| Phase | Phase 3 |
Mechanism of action
This therapy involves harvesting a small sample of the patient's own keratinocytes (skin cells), expanding them in culture to create a large sheet of living skin tissue, and then grafting this autologous cellular product onto burn wounds. The cultured keratinocytes restore the epidermal barrier, promote wound closure, reduce infection risk, and facilitate natural healing by providing viable skin cells that integrate with the patient's existing tissue.
Approved indications
- Severe thermal burns requiring skin grafting
Common side effects
- Graft failure or poor integration
- Infection at graft site
- Contracture formation
- Hypertrophic 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)
- Autologous Cellular Graft in Surgical Treatment of Vitiligo (NA)
- Biological Skin Graft With Keratinocyte-stem Cell Co-cultre for Burn Patients (EARLY_PHASE1)
- Treatment of Patients With Skin Burns Using Keratinocytes and Skin Fibroblasts (PHASE1, PHASE2)
- Autologous Keratinocyte Suspension Versus Adipose-Derived Stem Cell-Keratinocyte Suspension for Post-Burn Raw Area (NA)
- Application of Cultured Autologous Keratinocytes for Burn Wound Healing (PHASE3)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cultured autologous keratinocytes CI brief — competitive landscape report
- Cultured autologous keratinocytes updates RSS · CI watch RSS
- Association of Dutch Burn Centres portfolio CI
Frequently asked questions about Cultured autologous keratinocytes
What is Cultured autologous keratinocytes?
How does Cultured autologous keratinocytes work?
What is Cultured autologous keratinocytes used for?
Who makes Cultured autologous keratinocytes?
Is Cultured autologous keratinocytes also known as anything else?
What drug class is Cultured autologous keratinocytes in?
What development phase is Cultured autologous keratinocytes in?
What are the side effects of Cultured autologous keratinocytes?
Related
- Drug class: All Cell therapy; autologous cellular product drugs
- Manufacturer: Association of Dutch Burn Centres — full pipeline
- Therapeutic area: All drugs in Dermatology; Wound Care; Burn Treatment
- Indication: Drugs for Severe thermal burns requiring skin grafting
- Also known as: Cultured keratinocytes
- Compare: Cultured autologous keratinocytes vs similar drugs
- Pricing: Cultured autologous keratinocytes cost, discount & access