CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 101 enrolled
Drug / intervention
StemEx®drug
Likely dose
StemEx® 3 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00469729
NCT00469729Phase 3Completed
CompareCT.gov

A Multi-Center, Multi-National, Historical Cohort Controlled Study to Evaluate Efficacy and Safety of Transplantation of StemEx®, Umbilical Cord Blood Stem and Progenitor Cells Expanded Ex Vivo, in Subjects With Hematologic Malignancies Following Myeloablative Therapy

Gamida Cell -Teva Joint Venture Ltd.·interventional·Posted May 4, 2007·Updated Jul 10, 2015

In Brief

A Phase 3 clinical trial evaluating StemEx® for Hematologic Malignancies and 6 related conditions. Completed, enrolled 101 participants across 30 sites in 5 countries.

Detailed Summary

The purpose of this study is to determine the efficacy and safety of transplanting StemEx® in patients with certain hematological malignancies. For these patients, it is suggested that StemEx® can improve upon the outcome of transplanting a single, unmanipulated cord blood unit by significantly increasing the number of stem/progenitor cells available to the patient.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematologic Malignancies, Acute Myeloid Leukemia, Lymphoid Leukemia, Chronic Myeloid Leukemia, Hodgkin's Disease, Non-Hodgkin's Lymphoma, Myelodysplastic Syndromes
CountriesHungary, Israel, Italy, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 4, 2007
Enrollment StartOct 1, 2007
Primary CompletionFeb 1, 2013
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 19.2 years ago

Interventions

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.