New York Blood Center National Cord Blood Program

Early Phase 1

Terminated

• Conditions: Myelodysplasia; Lymphoma; Genetic Disease; Leukemia; Severe Aplastic Anemia
• Interventions: Biological: Umbilical Cord Blood Transplantation

• Registration Number: NCT00212407
• Lead Sponsor: New York Blood Center

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.

Study Timeline

• Study Start: 1993-02
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2011-11-10
• Study Completion: 2011-11-10
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-31
• Last Update Posted: 2018-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4476

Inclusion Criteria

• Candidates for bone marrow transplantation

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Umbilical cord blood unit(s) transplant	Umbilical Cord Blood Transplantation	Transplantation of cryopreserved umbilical cord blood unit(s)

Primary Outcome Measures

Name	Time	Method
Treatment Related Mortality	released prior to 12-1-2012
Engraftment	released prior to 12-1-2012
Survival	released prior to 12-1-2012

Secondary Outcome Measures

Name	Time	Method
Relapse	released prior to 12-1-2012
Graft vs. Host Disease	released prior to 12-1-2012

Trial Locations

Locations (1)

New York Blood Center; 🇺🇸 New York, New York, United States