Guided Bone Regeneration Clinical Trial
Official title:
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
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06139939 -
Guided Bone Regeneration for Horizontal Alveolar Ridge Augmentation With Double Layer Technique
|
N/A | |
| Not yet recruiting |
NCT03840681 -
Assessment of Guided Bone Regeneration in Atrophic Anterior Maxilla
|
N/A | |
| Completed |
NCT05143242 -
Contour Augmentation by Means of Connective Tissue Grafting Versus Guided Bone Regeneration
|
N/A | |
| Not yet recruiting |
NCT06286605 -
RCT GBR One Stages Comparing A-Oss and Autogenous Bone Versus A-Oss and LCR-A
|
N/A | |
| Recruiting |
NCT03225495 -
Comparison Between Ultra-narrow Diameter Implants (2,75 mm) Without Bone Regeneration Versus Standard Diameter Implants (4,3 mm) in Combination With Bone Regeneration
|
N/A | |
| Recruiting |
NCT06295055 -
Semi-rigid Shell Barrier System for Alveolar Bone Augmentation (SSBS for ABA)
|
N/A | |
| Not yet recruiting |
NCT04679766 -
Evaluation of Ice Cream Cone Technique With Immediate Implant Placement in Patients With Labial Plate Dehiscence
|
N/A | |
| Recruiting |
NCT06467630 -
Measurement of the Performance and Safety of RTR+Membrane in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures
|
||
| Not yet recruiting |
NCT06257225 -
Evaluation of Horizontal Bone Gain in the Lower Posterior Partially Edentulous Patient Comparing the Stabilization of Membranes With and Without Tacs
|
N/A | |
| Recruiting |
NCT05890469 -
Effect of Implant Surface Material and Topography on Bone Regeneration.
|
N/A |