Status:
COMPLETED
Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Cells, in Patients With HM
Lead Sponsor:
Gamida Cell ltd
Conditions:
Hematological Malignancies
Acute Lymphoblastic Leukemia (ALL)
Eligibility:
All Genders
12-65 years
Phase:
PHASE1
PHASE2
Brief Summary
A Study Evaluating the Safety and Efficacy of Transplantation of a single cord blood unit (CBU) of NiCord®, umbilical cord blood-derived Ex Vivo Expanded Stem and Progenitor Cells in Patients with Hem...
Detailed Description
Umbilical cord blood (UCB) is an alternative stem cell source for hematopoietic stem cell transplantations (HSCT) and can be used for the treatment of various life-threatening diseases, such as hemato...
Eligibility Criteria
Inclusion
- Applicable disease and eligible for myeloablative SCT
- Patients must have two partially HLA-matched CBUs
- Back-up stem cell source
- Adequate Karnofsky Performance score or Lansky Play-Performance scale
- Sufficient physiological reserves
- Signed written informed consent
Exclusion
- HLA-matched donor able to donate
- Prior allogeneic HSCT
- Other active malignancy
- Active or uncontrolled infection
- Active/symptoms of central nervous system (CNS) disease
- Pregnancy or lactation
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01816230
Start Date
April 1 2013
End Date
June 1 2018
Last Update
October 22 2020
Active Locations (15)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Loyola University, Cardinal Bernardin Cancer Center
Maywood, Illinois, United States, 60153
3
University of Minnesota
Minneapolis, Minnesota, United States, 55455
4
Steven and Alexandra Cohen Children's Medical Center
New York, New York, United States, 11040