NCT01816230

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

Study Contact:

Study Phase:

PHASE1

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT01816230

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

Allogeneic Stem Cell Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Stem and Progenitor Cells, in Adolescent and Adult Patients With Hematological Malignancies

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.

Eligibility

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

Disease(s) and\or Condition(s)

Hematological Malignancies

Acute Lymphoblastic Leukemia (ALL)

Acute Myeloid Leukemia (AML)

Myelodysplastic Syndrome (MDS)

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: NiCord®
- Description:
- Arm Group Labels: NiCord®

Sponsor

Gamida Cell ltd