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Autologous cultured keratinocyte cell
Autologous cultured keratinocyte cell is a Cell therapy Small molecule drug developed by Biosolution Co., Ltd.. It is currently in Phase 3 development for Severe burns, Chronic wounds, Diabetic ulcers. Also known as: Keraheal.
Autologous cultured keratinocytes are patient-derived skin cells grown in vitro and applied topically or as a graft to promote wound healing and tissue regeneration.
Autologous cultured keratinocytes are patient-derived skin cells grown in vitro and applied topically or as a graft to promote wound healing and tissue regeneration. Used for Severe burns, Chronic wounds, Diabetic ulcers.
At a glance
| Generic name | Autologous cultured keratinocyte cell |
|---|---|
| Also known as | Keraheal |
| Sponsor | Biosolution Co., Ltd. |
| Drug class | Cell therapy |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
This cell therapy involves harvesting keratinocytes from a patient's own skin, expanding them in culture, and then delivering them back to the patient to cover wounds or damaged skin areas. The cells promote re-epithelialization, restore the skin barrier, and stimulate natural healing processes. This autologous approach minimizes immune rejection risk since the cells are derived from the patient themselves.
Approved indications
- Severe burns
- Chronic wounds
- Diabetic ulcers
Common side effects
- Infection at graft site
- Graft failure or poor take
- Scarring
- Contracture
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)
- Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood (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:
- Autologous cultured keratinocyte cell CI brief — competitive landscape report
- Autologous cultured keratinocyte cell updates RSS · CI watch RSS
- Biosolution Co., Ltd. portfolio CI
Frequently asked questions about Autologous cultured keratinocyte cell
What is Autologous cultured keratinocyte cell?
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Related
- Drug class: All Cell therapy drugs
- Manufacturer: Biosolution Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Severe burns
- Indication: Drugs for Chronic wounds
- Indication: Drugs for Diabetic ulcers
- Also known as: Keraheal
- Compare: Autologous cultured keratinocyte cell vs similar drugs
- Pricing: Autologous cultured keratinocyte cell cost, discount & access