Status:
WITHDRAWN
Allogenic Transplantation of Ex-vivo Expanded Cord Blood (CB)
Lead Sponsor:
Dr. Avichai Shimoni MD
Collaborating Sponsors:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Umbilical Cord Blood
Stem Cell Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The aim of this study is to evaluate the safety profile and tolerability of infusion of cord blood cells expanded in the lab and to evaluated whether through the infusion of expanded cells it is possi...
Detailed Description
Stem cell transplantation is a curative approach for patients with hematological malignancies. Umbilical cord blood is a source of stem cells for transplantation in patients with no related donor. How...
Eligibility Criteria
Inclusion
- age \> 18 years
- hematological malignancy
- standard indication for allogeneic transplantation
- expected survival time over 12 weeks
- no related or unrelated donor
- availability of a cord blood unit of compatible placental blood cryopreserved in at least 2 different bags; one of the two units should have a cellular content at least equal to the minimum dose of 2 x 107 nucleated cells per kilogram of body weight
Exclusion
- Eastern Cooperative Oncology Group (ECOG) performance status \>2
- Prior allogeneic transplantation
- Pregnant or nursing women
- Positive serology for hepatitis B or C
- HIV positive
- Left ventricular ejection fraction \< 50%
- DLCO \< 50%
- Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study
- Treatment with other investigational drugs within 4 weeks of enrolling in this protocol
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01235468
Start Date
June 1 2012
End Date
November 1 2015
Last Update
December 3 2015
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