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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00469729 | Efficacy and Safety Study of StemEx®, to Treat Subjects With High Risk Hematologic Malignancies, Following Myeloablative Therapy | PHASE2 | COMPLETED | 101 | — | — | Oct 1, 2007 | Jun 1, 2015 | Jul 10, 2015 | 30 | United States, Hungary +3 |
| Arm | Type | Description |
|---|---|---|
| StemEx | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| StemEx® | DRUG | The stem/progenitor cell based product composed of ex vivo expanded allogeneic umbilical cord blood cells, which is infused to subject at a rate of 1-3 ml/min in combination with non-manipulated cells derived from the same cord blood unit. |
Inclusion Criteria: 1. Clinical diagnosis of AML or ALL: CR2 or subsequent complete remission (CR) or CR1 with high-risk features or relapse with \< 10% blasts in BM and no circulating blasts. 2. Clinical diagnosis of CML: in CP1 (Chronic Phase 1) and resistant or intolerant to Gleevec or in CP2 or...