A Phase 1/2 interventional study of implantation with an autologous human palatal mucosa substitute made of nanostructured fibrin-agarose generated by tissue engineering (BIOCLEFT). in Cleft Lip and Palate, sponsored by Elisa María Cubiles Montero de Espinosa. Recruiting at 1 site in Spain. Open to participants aged 10 Months to 14 Months. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by Elisa María Cubiles Montero de Espinosa · Phase 1/2, Interventional, and Treatment
Phase I/II, controlled, open-label, randomized, single site clinical trial to assess the safety and feasibility, as well as hint efficacy evidence of a bioengineered palate mucosa substitute on nanostructured fibrin-agarose scaffolds with autologous mucosa tissue-specific cells (culture-expanded fibroblasts and keratinocytes), for tissue replacement and repair of donor area after the reconstruction of palate cleft defects (staphylorraphy), in comparison with standard care for donor mucosa.
The initial phase of the trial is non-randomized, and involves the sequential recruitment of 5 eligible subjects with a minimum safety period of 30 days between them. All of them will be implanted with the autologous human palatal mucosa substitute of nanostructured fibrin-agarose generated by tissue engineering (BIOCLEFT), after reconstruction of the palate. Once the 5th treated patient has reached 1.5 months of follow-up after the intervention (Visit 8), the safety and feasibility data analysis will be carried out by the Independent Data Safety and Monitoring Committee (interim analysis), after which will allow continuation to the randomized phase of the trial, if the results allow it.
In the second phase, the rest of the patients (10) will be recruited, who will be randomized 1:1, such that 5 of these patients will be implanted with the investigational medication while undergoing standard surgical reconstruction. (uranostaphyllorrhaphy), while the other 5 will only undergo standard surgical reconstruction and will constitute the control group.
The total number of patients to be included in the study will be 15, who will be followed for 24 months according to a protocolized scheme that includes 2 pre-implant visits, 1 implant visit and 9 post-implant evaluation visits.
Exclusion Criteria:
The experimental group will be implanted with an autologous human palatal mucosa substitute made of nanostructured fibrin-agarose generated by tissue engineering (BIOCLEFT). The implantation of this advanced therapy medication will cover the lateral defect generated by the mobilization of fibromucous flaps during standard surgery (uranostaphylorrhaphy
Procedure: implantation with an autologous human palatal mucosa substitute made of nanostructured fibrin-agarose generated by tissue engineering (BIOCLEFT).
These patients will be included in the control group and will receive the usual treatment for their disease (uranoestafilorrafia), without applying any type of restriction to the area used for the movement of the arms.
cleft palate repair surgery, all patients in the study will receive the standard treatment (uranostaphyllorrhaphy), with the only difference that patients assigned to the experimental study group will additionally have BIOCLEFT tissue obtained through tissue engineering grafted onto them. the lateral area of the palatine bone exposed when mobilizing the flaps. For the implant, the BIOCLEFT fabric will be placed in the area of exposed bone, sized to the size of the defect and sutured using uncoated, monofilament long-term absorbable synthetic suture.
Evaluate implant´s feasibility and appearance of adverse events and serious adverse events related to treatment
Incidence of Serious Adverse Events after at the time of the implant of study drug.
Time frame: 24 months
Evaluation of the time of the regeneration and healing of the lateral defect of the palatine bone from the moment of the intervention
Time frame: 24 months
Evaluation of the aesthetic result through analysis of photographs
A scale designed ad hoc for the present trial will be used (aesthetic appearance assessment scale)
Time frame: 24 months
Preliminary evaluation of craniofacial growth through analysis of craniofacial photographs
Time frame: 24 months
Hearing evaluation
Otoscopic/otomicroscopic examination and tympanogram by the otorhinolaryngologist, and placement of aeration tubes if considered necessary. The need or not to perform follow-up during the trial visits will be assessed depending on whether or not the patient presents any type of pathology.
Time frame: 24 months
Quality of life evaluation
Changes in quality of life will be assessed through the TAPQOL questionnaire for children between 1-5 years old.
Time frame: 24 months
Functional evaluation by the speech therapist
Evaluation of nasal escape; palate mobility; swallowing and articulation of functional language by the speech therapist.
Time frame: 24 months
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