New York Blood Center National Cord Blood Program

NCT ID: NCT00212407

Last Updated: 2018-11-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 4476 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1993-02-28
• Study Completion Date: 2011-11-10

Brief Summary

Umbilical cord blood is used as a source of hematopoietic stem cells for bone marrow reconstitution in patients who would be potential candidates for a bone marrow transplant from an unrelated marrow donor. The outcome of transplantation is obtained to assess cord blood myeloid and platelet engraftment, transplant related mortality, overall survival, graft vs. host disease and, for patients with leukemia, lymphoma or myelodysplasia, relapse.

Detailed Description

Umbilical cord blood donated to the New York Blood Center's National Cord Blood Program is collect, tested, processed, cryoprotected and frozen in liquid nitrogen for possible future transplantation to anyone who needs it. The Program has operated under a FDA IND exemption since 1996 and is licensed as a tissue bank by the New York State Department of Health.

Candidates for transplant are patients who disease requires bone marrow transplantation but who do not have a suitable related bone marrow donor. Most patients are those with high risk of refractory leukemia, lymphoma, myelodysplasia, severe aplastic anemia and certain genetic hematologic, immunologic and metabolic diseases.

Patients are treated at bone marrow transplant centers in the United States and in other countries with active marrow transplant programs. Because the NYBC Program operates under IND, patients must sign an informed consent for cord blood transplantation.

Transplant centers report on the transplant procedure (including immediate complications) and on transplant outcome at 3, 6 and 12 months post-transplant and annually thereafter. Data report to the New York Blood Center includes information about the patient's disease and pre-transplant conditioning regimen and post-transplant endpoints, primarily myeloid and platelet engraftment, transplant related mortality, overall survival, acute and chronic graft vs. host disease, relapse and other post-transplant complications such as infectious disease. The outcome data is used to assess safety and efficacy and will be used to apply for a license from the FDA.

Conditions

Leukemia; Lymphoma; Genetic Disease; Severe Aplastic Anemia; Myelodysplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Umbilical cord blood unit(s) transplant

Transplantation of cryopreserved umbilical cord blood unit(s)

Group Type: EXPERIMENTAL

Umbilical Cord Blood Transplantation

Intervention Type: BIOLOGICAL

Interventions

Umbilical Cord Blood Transplantation

Intervention Type: BIOLOGICAL

Other Intervention Names

One or more matched umbilical cord blood units for transplant

Eligibility Criteria

Inclusion Criteria

• Candidates for bone marrow transplantation

Exclusion Criteria

-

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York Blood Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pablo Rubinstein, M.D.

Role: PRINCIPAL_INVESTIGATOR

New York Blood Center

Locations

New York Blood Center

New York, New York, United States

Countries

United States

Other Identifiers

234

Identifier Type: -

Identifier Source: org_study_id