Pilot Study Evaluating Safety & Efficacy of DCBT: NiCord® & UNM CBU to Patients With Hematological Malignancies

Completed · Phase 1/Phase 2

Conditions studied: Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS), Non-Hodgkin's Lymphoma, Hodgkin's Disease

In brief

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 with Hematological Malignancies

Key facts

Study ID

NCT01221857

Run by

Gamida Cell ltd

People needed

12

Starts

2010-11-01

Expected to finish

2013-05-01

Last updated by the study team

2021-08-03

Who can join

Age: 8 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Loyola University, Cardinal Bernardin Cancer Center — Maywood, Illinois, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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