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Also known as Tissue Repair Cells (TRC)
Tissue Repair Cells · 1 trial · 1 indication
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...
Tissue Repair Cells is being studied for the treatment of alveolar bone loss, a condition involving loss of bone in the jaw. It is an investigational cell-based therapy developed by Vericel Corporation. The only recorded clinical trial evaluated its use in treating alveolar bone defects.
Tissue Repair Cells is developed by Vericel Corporation, which trades on the Nasdaq under the ticker VCEL. The company is the sponsor of the clinical program for this cell therapy candidate.
Tissue Repair Cells is in Phase 1 clinical development. The single completed trial, NCT00755911, was a Phase 1 study. It is an investigational therapy and has not been approved by the FDA for any indication.
Tissue Repair Cells has been evaluated in one completed clinical trial, NCT00755911, titled Treatment of Alveolar Bone Defects Using Aastrom Biosciences Autologous Tissue Repair Cell Therapy. The Phase 1 study enrolled 24 participants in the United States and was sham-controlled and randomized.
Yes, Tissue Repair Cells is also known as TRC, short for Tissue Repair Cells. Both names refer to the same investigational cell therapy developed by Vericel Corporation for alveolar bone loss.