Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00755911 | Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy | PHASE1 | COMPLETED | 24 | — | — | Jun 1, 2008 | May 1, 2012 | Jul 3, 2015 | 1 | United States |
The primary objective of this study is to determine whether the placement of Tissue Repair Cells (TRCs) at the time of tooth extraction can safely and effectively promote bone regeneration in alveolar bone defects created by tooth extraction. * Safety was assessed through adverse event reporting * Bone regeneration was assessed through measures of bone mineral density and bone volume fraction of biopsied regenerated bone tissue. Bone regeneration was also measured through radiographic analysis of relative bone height gain (% of the bone height regenerated relative to the height before tooth extraction)
| Arm | Type | Description |
|---|---|---|
| Tissue Repair Cells (TRC) | EXPERIMENTAL | Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier |
| Control | SHAM_COMPARATOR | Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy. |
| Name | Type | Description |
|---|---|---|
| Tissue Repair Cells (TRC) | BIOLOGICAL | 30-50 ml of bone marrow is aspirated from subject and processed into TRC autologous bone marrow tissue graft. 10ml of TRC will be absorbed onto gelfoam carrier and placed in extraction socket. |
| Control | DEVICE | Control subjects only receive standard gelfoam carrier. It promotes healing after tooth extraction |
Inclusion Criteria: * Age range: 20 to 70 years * Gender: Male and female * Patients must be able and willing to follow study procedures and instructions * Patients must have read, understood and signed an informed consent form * Patients must require tooth extraction as a result of caries, periodo...