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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 4 Years
Max Age: 75 Years

Referral Letter Required


Population Exclusion(s)



Umbilical Cord Blood;
Graft Rejection;
Graft Versus Host Disease

Recruitment Keyword(s)



Myelodysplastic Syndrome (MDS);
Hematologic Neoplasms;
Hematologic Diseases;
Severe Aplastic Anemia

Investigational Drug(s)

Cryopreserved Cord Blood Units (CBU)

Investigational Device(s)



Biological/Vaccine: Cord Blood Transplant

Supporting Site

National Heart, Lung and Blood Institute


- 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.


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


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


- 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.

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-Patients of 4-75 years of age with FDA-specified indications

-Signed informed consent (and assent when applicable) obtained prior to study enrollment


-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


-Treatment description, including pre-transplant conditioning and GVHD prophylaxis, will occur per

each transplant center s specification.

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Kurtzberg J, Laughlin M, Graham ML, Smith C, Olson JF, Halperin EC, Ciocci G, Carrier C, Stevens CE, Rubinstein P. Placental blood as a source of hematopoietic stem cells for transplantation into unrelated recipients. N Engl J Med. 1996 Jul 18;335(3):157-66.

Wagner JE, Rosenthal J, Sweetman R, Shu XO, Davies SM, Ramsay NK, McGlave PB, Sender L, Cairo MS. Successful transplantation of HLA-matched and HLA-mismatched umbilical cord blood from unrelated donors: analysis of engraftment and acute graft-versus-host disease. Blood. 1996 Aug 1;88(3):795-802.

Laughlin MJ, Barker J, Bambach B, Koc ON, Rizzieri DA, Wagner JE, Gerson SL, Lazarus HM, Cairo M, Stevens CE, Rubinstein P, Kurtzberg J. Hematopoietic engraftment and survival in adult recipients of umbilical-cord blood from unrelated donors. N Engl J Med. 2001 Jun 14;344(24):1815-22.

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Principal Investigator

Referral Contact

For more information:

Richard W. Childs, M.D.
National Heart, Lung and Blood Institute (NHLBI)
BG 10-CRC RM 3-5330
(301) 451-7128

Jennifer S. Wilder, R.N.
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 3-3121
10 Center Drive
Bethesda, Maryland 20892
(301) 451-3722

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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