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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00212407
Other study ID # 234
Secondary ID
Status Terminated
Phase Early Phase 1
First received
Last updated
Start date February 1993
Est. completion date November 10, 2011

Study information

Verified date October 2018
Source New York Blood Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 4476
Est. completion date November 10, 2011
Est. primary completion date November 10, 2011
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Candidates for bone marrow transplantation

Exclusion Criteria:

Study Design


Intervention

Biological:
Umbilical Cord Blood Transplantation


Locations

Country Name City State
United States New York Blood Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York Blood Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Engraftment released prior to 12-1-2012
Primary Treatment Related Mortality released prior to 12-1-2012
Primary Survival released prior to 12-1-2012
Secondary Graft vs. Host Disease released prior to 12-1-2012
Secondary Relapse released prior to 12-1-2012
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