NCT01221857

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

Study Contact:

Study Phase:

PHASE1

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT01221857

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 Combination With a Second, Unmanipulated Cord Blood Unit in Patients With Hematological Malignancies

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

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 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

Disease(s) and\or Condition(s)

Acute Lymphoblastic Leukemia (ALL)

Acute Myelogenous Leukemia (AML)

Myelodysplastic Syndrome (MDS)

Non-Hodgkin's Lymphoma

Hodgkin's Disease

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: NiCord®
- Description: NiCord® is a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells.
- Arm Group Labels: NiCord

Sponsor

Gamida Cell ltd