Status:
COMPLETED
Pilot Study Evaluating Safety & Efficacy of DCBT: NiCord® & UNM CBU to Patients With Hematological Malignancies
Lead Sponsor:
Gamida Cell ltd
Conditions:
Acute Lymphoblastic Leukemia (ALL)
Acute Myelogenous Leukemia (AML)
Eligibility:
All Genders
8-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Pilot Study Evaluating the Safety and Efficacy of a Co-Transplantation of NiCord®, a UCB-derived ex Vivo Expanded Population of Stem and Progenitor Cells with a Second, Unmanipulated CBU in Patients w...
Detailed Description
Allogeneic hematopoietic stem cell transplantation (HSCT) is a potentially curative procedure for various hematological malignancies, bone marrow failure syndromes and inherited metabolic disorders. T...
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 related donor able to donate
- Prior allogeneic HSCT
- Lymphoma patients with progressive disease
- Other active malignancy
- Human immunodeficiency virus (HIV) infection
- Active or uncontrolled infection
- Active/symptoms of central nervous system (CNS) disease
- Pregnancy or lactation
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01221857
Start Date
November 1 2010
End Date
May 1 2013
Last Update
August 3 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Loyola University, Cardinal Bernardin Cancer Center
Maywood, Illinois, United States, 60153
2
Duke University Medical Center
Durham, North Carolina, United States, 27705