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BIOCLEFT
- Development stage
- Unknown
- Lead developer
- Fundacion Publica Para La Investigacion Biosanitaria De Andalucia Oriental Alejandro Otero
- Modality
- Cell Therapies, Implantable Hydrogels → Hydrogel Systems → Drug Delivery Systems, Injectable Hydrogels → Hydrogel Systems → Drug Delivery Systems, Implantable Devices → Device-based Delivery → Drug Delivery Systems
- Administration
- Implant
01
Overview
**BIOCLEFT** is an investigational, patient-specific tissue-engineered advanced therapy medicinal product for repair of cleft palate. It is produced from autologous oral-mucosa fibroblasts and keratinocytes expanded ex vivo and organized into a bilayer-like palatal mucosa substitute using a nanostructured fibrin-agarose matrix. The graft is implanted during palate reconstruction to provide living stromal and epithelial tissue intended to support mucosal regeneration, wound healing, and repair of the palatal defect. BIOCLEFT is being evaluated in a randomized Phase I-IIa study in pediatric patients with unilateral cleft lip and palate. ([pmc.ncbi.nlm.nih.gov](https://pmc.ncbi.nlm.nih.gov/articles/PMC11624797/))
- Other names
- autologous tissue-engineered nanostructured fibrin-agarose oral mucosa substituteautologous oral mucosa-derived adult keratinocytes and fibroblasts in fibrin-agarose matrix
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