Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408337
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-04-25
Brief Title:
Phase I-IIa to Evaluate the Safety Feasibility and Efficacy of the Use of BIOCLEFT in the Treatment of Cleft Palate
Sponsor:
Elisa María Cubiles Montero de Espinosa
Organization:
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Study Overview
Official Title:
Phase I-IIa Randomized Controlled Open-label Single-center Clinical Trial to Evaluate Safety Feasibility and Efficacy of the Use of BIOCLEFT in the Treatment of Patients With Cleft Palate
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase III 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
Detailed Description:
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 15 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 11 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
In the second phase the rest of the patients 10 will be recruited who will be randomized 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None