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

Phase 1 Unknown 24 enrolled Taipei Medical University

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2018-08-10
Primary completion: 2019-12-12
Completion: 2021-04-25

Publications

Background Schneider R. Prosthetic concerns about atrophic alveolar ridges. Postgrad Dent. 1999;6(2):3-7.
Background de Baat C, Kalk W, van 't Hof M. Factors connected with alveolar bone resorption among institutionalized elderly people. Community Dent Oral Epidemiol. 1993 Oct;21(5):317-20. doi: 10.1111/j.1600-0528.1993.tb00783.x.
Feng SW, Su YH, Lin YK, Wu YC, Huang YH, Yang FH, Chiang HJ, Yen Y, Wang PD. Small blood stem cells for enhancing early osseointegration formation on dental implants: a human phase I safety study. Stem Cell Res Ther. 2021 Jul 2;12(1):380. doi: 10.1186/s13287-021-02461-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SB cells	Unknown	100000 cells	—
Subject	SB cells	Unknown	1e+06 cells	—
Subject	SB cells	Unknown	1e+07 cells	—

Indications

No indication recorded.