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A Phase I Study of SB Cell for the Enhanced Osseointegration of Guided Bone Regeneration in Implant Surgery

A Phase I Study of SB Cell for the Enhanced Osseointegration of Guided Bone Regeneration in Implant Surgery

Recruiting
20 years and older
All
Phase 1

This is a Phase 1 study to evaluate the safety profile of autologous-derived SB cells to enhance osseointegration of GBR in patients undergoing dental implant surgery.

Enrolled subjects eligible to receive GBR procedure will be sequentially assigned to 1 of 3 treatment cohorts as follows:

Treatment dose 1 group1105 CD61-Lin- cells /0.25mL DPBS Treatment dose 2 group1106 CD61-Lin- cells /0.25mL DPBS Treatment dose 3 group110*7 CD61-Lin- cells /0.25mL DPBS

After receiving the autologous SB cells solution mixed with 1 mL bone substitute, each first treated subject at each cohort will be followed up to 4-weeks. After the first subject at each cohort (3 subjects) complete a 4-weeks follow-up period, if investigator and sponsor judge that there is not either a safety concern or a dose-limiting toxicity (DLT) criteria is not met, 2 additional subjects within each cohort will be enrolled. A Data Safety Monitoring Committee will be conveyed after the first 3 treated subjects at each cohort complete undergo the dental implant procedure (12-weeks follow-up after GBR) to evaluate the safety and preliminary efficacy of SB cells administered during a GBR procedure, and will provide recommendations regarding study modification, continuation to enroll next subject(s), cohorts or study termination.

If the committee recommends further subject enrollment, sequential recruitment will continue until subjects for each treatment cohort are enrolled, treated and followed up to 24-weeks after GBR (12-weeks after dental implant) unless there is a safety concern judged by investigator, sponsor, or a dose-limiting toxicity (DLT) criteria is met. Once this situation occurs, the committee will assess the progress and safety data of all subjects enrolled, and will provide recommendations regarding study modification, continuation to enroll next subject in that or other cohorts, or will recommend study termination.

Study details
    Guided Bone Regeneration

NCT04451486

Taipei Medical University

19 February 2024

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