NCT04451486

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

A Phase I Study to Evaluate The Use of Autologous-Derived Adult Peripheral Small Blood Stem Cells to Enhance Osseointegration of Guided Bone Regeneration in Implant Surgery

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Taipei Medical University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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 group：1×10\*5 CD61-Lin- cells /0.25mL DPBS Treatment dose 2 group：1×10\*6 CD61-Lin- cells /0.25mL DPBS Treatment dose 3 group：1×10\*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.

Conditions

• Guided Bone Regeneration

Interventions

Type	Name	Description
DRUG	SB cells	1x10\*5 CD61-Lin- cells /0.25mL DPBS
DRUG	SB cells	1x10\*6 CD61-Lin- cells /0.25mL DPBS
DRUG	SB cells	1x10\*7 CD61-Lin- cells /0.25mL DPBS

Timeline

• Start date: 2018-08-10
• Primary completion: 2019-12-12
• Completion: 2021-04-25
• First posted: 2020-06-30
• Last updated: 2020-06-30

Locations

1 site across 1 country: Taiwan