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StemEx · 1 trial · 7 indications
| 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...
StemEx is being studied for the treatment of high risk hematologic malignancies, including acute myeloid leukemia, lymphoid leukemia, chronic myeloid leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, and myelodysplastic syndromes. It is given following myeloablative therapy in patients aged 12 years and older.
StemEx is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company sponsored the clinical study evaluating the therapy in patients with high risk hematologic malignancies following myeloablative therapy.
StemEx is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 2 study evaluating its efficacy and safety in high risk hematologic malignancies has been completed.
StemEx has been evaluated in one clinical trial, NCT00469729, titled Efficacy and Safety Study of StemEx to Treat Subjects With High Risk Hematologic Malignancies Following Myeloablative Therapy. The Phase 2 trial enrolled 101 participants across the United States, Hungary, Israel, Italy, and Spain, and it is now completed.
Yes, StemEx and StemEx® refer to the same investigational therapy developed by Teva Pharmaceutical Industries Limited. The registered trademark symbol is simply a stylized version of the same product name.