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

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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 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 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