IRB #

STUDY00015460

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

Principal Investigator

Richard Maziarz

Study Purpose

This study evaluates the safety and efficacy of NiCord, a cell-based product produced from a single expanded umbilical cord blood stem cell unit for patients with hematological malignancies receiving a bone marrow transplant.

The main hypothesis is that the use of NiCord following myeloablative conditioning will provide sustained engraftment.

Medical Condition(s)

Bone marrow transplant engraftment and recovery

Eligibility Criteria

Patients included in the study must be 12 to 65 years of age and have one of the following hematologic malignancies: ALL, AML, CML, MDS, or certain types of lymphoma, and be eligible for myeloablative stem cell transplant. Patients must have at least two partially HLA-matched umbilical cord blood units available, have adequate performance status, adequate physiological reserves, and signed written informed consent.

Patients are excluded from the study if they have:
- An HLA-matched donor able to donate
- Received a prior bone marrow transplant
- Another active malignancy
- An active or uncontrolled infection
- Symptoms of central nervous system disease
- If they are pregnant

Age Range

12 - 65

Healthy Volunteers Needed

No

Duration of Participation

The total duration of the study is about 13 months from signing the consent form to the last visit one year after transplant. After completing the study you may have the option to participate in a long term follow-up study. This will be explained to you near the end of this study and you will be asked to sign a separate consent form.

Minors Included

Yes

Contact

OHSU Knight Cancer Institute
Center for Hematologic Malignancies
Beth Zentzis, Study Coordinator
503-346-1507

Sponsor

Gamida

Recruitment End

12/31/2017

Compensation Provided

No


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