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Providing Access to Cord Blood Units for Transplants

NCT01479582 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-12-21

No results posted yet for this study

Summary

Background:

\- Cord blood banks have been set up to collect and store umbilical cord blood for transplants. These transplants are used to treat different types of cancer. In October 2011, the Food and Drug Administration (FDA) began considering cord blood as a biological drug. Most of the cord blood units currently available in cord blood banks in the United States and other countries were collected before the FDA set these new standards. The units meet standards set by the National Marrow Donor Program (NMDP), but they were not collected, tested, or stored exactly according to FDA standards. As a result, the new guidelines state that they may only be used for transplant if the transplant is done as part of a study. Researchers have set up a study to provide these cord blood units to recipients and to study the effects of their use.

Objectives:

* To provide access to cord blood units for recipients whose best choice for a unit meets NMDP but not FDA standards.
* To study the effects of these cord blood transplants.

Eligibility:

\- Individuals who need to have a cord blood transplant to treat certain types of cancer.

Design:

* Participants will be screened with a physical exam, medical history. They will also have blood tests and imaging studies.
* Participants will have the cord blood transplant and allow their medical data to be collected by the study researchers.

Conditions

Interventions

DRUG

Access to unlicensed cord blood units

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Ronald E Gress, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-27
Primary Completion
2012-11-26
Completion
2012-11-26

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01479582 on ClinicalTrials.gov