drugset / Trial / NCT02765997

StemRegenin-1 Expanded vs Unexpanded UCB for High Risk Heme Malignancies

NCT02765997 ↗

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

EvaluationDrugModalityDoseRoute
Subject SR-1 UCB Cell therapy — —
Comparator Unmanipulated UCB Cell therapy — —