Phase I-IIa, randomized, controlled, open-label, single-center clinical trial to evaluate the safety, feasibility, and evidence of efficacy of the use of an autologous tissue-engineered nanostructured fibrin-agarose oral mucosa substitute for human palatal mucosa in the treatment of patients with cleft palate

Conditions

Cleft lip and palate

Brief summary

Feasibility: if in at least 3 of the 5 patients in the initial phase it can be verified that the surgical implantation of the BIOCLEFT has been carried out satisfactorily; Safety: occurrence of any adverse event, serious or non-serious, and specifically, those adverse events and serious adverse events related to treatment and indications of efficacy regeneration and healing; aesthetic appearance; craniofacial growth; hearing evaluation; speech therapist and quality of life

Antonio España‐López, Ricardo Fernández‐Valadés, Elisa Cubiles, Ingrid Garzón, Miguel Ángel Martín‐Piedra et al. (20 authors)

BMJ Open2024-12-011 citations

10.1136/bmjopen-2024-093491

Interventions

DRUGAutologous oral mucosa differentiated adult keratinocytes and fibroblasts|expanded in biological fibrin-agarose matrix

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Feasibility: if in at least 3 of the 5 patients in the initial phase it can be verified that the surgical implantation of the BIOCLEFT has been carried out satisfactorily; Safety: occurrence of any adverse event, serious or non-serious, and specifically, those adverse events and serious adverse events related to treatment and indications of efficacy regeneration and healing; aesthetic appearance; craniofacial growth; hearing evaluation; speech therapist and quality of life	—

Measure

Time frame

Feasibility: if in at least 3 of the 5 patients in the initial phase it can be verified that the surgical implantation of the BIOCLEFT has been carried out satisfactorily; Safety: occurrence of any adverse event, serious or non-serious, and specifically, those adverse events and serious adverse events related to treatment and indications of efficacy regeneration and healing; aesthetic appearance; craniofacial growth; hearing evaluation; speech therapist and quality of life

—

Countries

Spain

Outcome results

None listed