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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00225095 | A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy | PHASE1 | COMPLETED | 60 | — | — | Sep 1, 2005 | Apr 1, 2008 | Dec 27, 2021 | 8 | United States |
Changes in meniscal volume over the course of the study as determined by MRI
| Arm | Type | Description |
|---|---|---|
| Chondrogen - dose 1 | ACTIVE_COMPARATOR | Chondrogen - 50 million cells |
| Chondrogen - dose 2 | ACTIVE_COMPARATOR | Chondrogen - 150 million cells |
| Vehicle Control | OTHER | Vehicle Control |
| Name | Type | Description |
|---|---|---|
| Mesenchymal Stem Cells | DRUG | - |
| Hyaluronan | DRUG | - |
Inclusion Criteria: * Age 18 to 60, inclusive * In need of medial meniscectomy * Normal axial alignment * Stable knee- previous ligament reconstruction, if stable * Removal of at least 50% of the affected portion of the medial meniscus * Intact articular cartilage in posterior meniscal weight-beari...