drugset / Trial / NCT02765997
StemRegenin-1 Expanded vs Unexpanded UCB for High Risk Heme Malignancies
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open label, interventional, randomized phase II trial comparing StemRegenin-1 (SR-1) cultured umbilical cord blood (experimental arm) to unmanipulated umbilical cord blood (standard of care arm) transplantation after a myeloablative CY/FLU/TBI conditioning. A 2:1 randomization will be employed with a higher chance of being assigned to the experimental arm.
Timeline
- Start
- 2017-04
- Primary completion
- 2020-06
- Completion
- 2022-06
Outcome
Outcome not reported
Stopped: “IRB Disapproval”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SR-1 UCB | Cell therapy | — | — |
| Comparator | Unmanipulated UCB | Cell therapy | — | — |