We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 19 of 35 for:    Lung Transplant | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Transplants With Unlicensed Preserved Cord Blood

This study is currently recruiting participants.
Verified November 24, 2017 by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01553461
First Posted: March 14, 2012
Last Update Posted: November 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
  Purpose

Background:

- Cord blood transplants can treat cancers and other diseases in children and adults. The U.S. Food and Drug Administration (FDA) requires cord blood to be collected and stored under certain safety standards. However, most available cord blood units were collected before the FDA set these standards. These units may not meet FDA standards, but they do meet similar standards set and followed by the National Marrow Donor Program (NMDP). Cord blood units that do not meet the new FDA standards may be used for transplants only as part of a research study. Doctors want to allow people who need transplants to receive cord blood that meets NMDP standards but may not meet FDA standards.

Objectives:

- To allow selected cord blood units that do not meet current FDA standards to be used for transplant.

Eligibility:

- Individuals who need cord blood units for transplant, and who best match cord blood units that are not FDA-licensed.

Design:

  • Participants will provide consent to receive cord blood that meets NMDP standards but may not meet FDA standards.
  • Participants will remain on the study for observation for up to 1 year after transplant, or until they withdraw from the study for personal or medical reasons.

Condition Intervention Phase
Myelodysplastic Syndrome (MDS) Hematologic Neoplasms Hematologic Diseases Severe Aplastic Anemia Procedure: Cord Blood Transplant Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):

Primary Outcome Measures:
  • To examine the incidence of neutrophil recovery of greater than or equal to 500/mm (3) after unlicensed CBU transplant.

Secondary Outcome Measures:
  • Assess incidence of graft rejection, transmission of infection, serious infusion reactions.
  • Determine 1 year survival.
  • Assess cumulative incidence of acute GVHD (grades II to IV), (grades III to IV), and incidence of chronic GVHD.

Estimated Enrollment: 500
Study Start Date: February 2, 2012
Estimated Study Completion Date: October 20, 2036
Estimated Primary Completion Date: October 20, 2036 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
  • Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment
  • Pediatric and adult patients of any age

EXCLUSION CRITERIA:

  • Patients who are receiving only licensed CBUs
  • Cord blood transplant recipients at international transplant centers
  • Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)
  • Patients whose selected unlicensed CBU(s) will be more than minimally manipulated
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553461


Contacts
Contact: Richard W Childs, M.D. (301) 451-7128 childsr@nhlbi.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Richard W Childs, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Publications:
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT01553461     History of Changes
Other Study ID Numbers: 120064
12-H-0064
First Submitted: March 13, 2012
First Posted: March 14, 2012
Last Update Posted: November 28, 2017
Last Verified: November 24, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Transplant
Umbilical Cord Blood
Graft Rejection
Graft Versus Host Disease

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Anemia, Aplastic
Hematologic Diseases
Hematologic Neoplasms
Bone Marrow Diseases
Precancerous Conditions
Neoplasms
Anemia
Neoplasms by Site