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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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 with Hematological Malignancies

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gamida Cell ltd

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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