Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Cells, in Patients With HM

Completed · Phase 1/Phase 2

Conditions studied: Hematological Malignancies, Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)

In brief

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 Hematological Malignancies.

Key facts

Study ID

NCT01816230

Run by

Gamida Cell ltd

People needed

36

Starts

2013-04-01

Expected to finish

2018-06-01

Last updated by the study team

2020-10-22

Who can join

Age: 12 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 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

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Loyola University, Cardinal Bernardin Cancer Center — Maywood, Illinois, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Steven and Alexandra Cohen Children's Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Vanderbilt — Nashville, Tennessee, United States
• Children Hospital Gaslini Scientific Institute — Genoa, Italy
• University of Turin — Turin, Italy
• University Medical Center Utrecht — Utrecht, Netherlands
• National University Cancer Institute — Singapore, Singapore
• Singapore General Hospital — Singapore, Singapore
• University Hospital Vall d´Hebron — Barcelona, Spain
• Hospital Universitario La Fe — Valencia, Spain

Full record on ClinicalTrials.gov

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