Safety Study of Cord Blood Units for Stem Cell Transplants
|
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. |
| ClinicalTrials.gov Identifier: NCT01861093 |
|
Recruitment Status :
Recruiting
First Posted : May 23, 2013
Last Update Posted : March 17, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Background:
- Cord blood is blood that is taken from the umbilical cord and placenta of healthy newborns after childbirth. The cord blood collected from a baby is called a cord blood unit. Cord blood units are stored frozen in public cord blood banks. About 10,000 cord blood transplants have been performed in children and adults for blood cancers and other diseases in the world. These transplants have helped save lives and improve treatments. However, not all available units of cord blood have been collected, stored, and licensed according to specific government requirements. These unlicensed units can still be used in transplant, but they can only be given as part of specific research studies. This study will evaluate the safety of giving these unlicensed units by recording any problems that may occur during and after giving the cord blood.
Objectives:
- To test the safety and effectiveness of unlicensed cord blood units in people who need stem cell transplants.
Eligibility:
- Individuals who are scheduled to have a stem cell transplant.
Design:
- Participants will be screened with a medical history and physical exam.
- Participants will receive the cord blood unit as part of their stem cell transplant procedure. The transplant will be performed according to the current standard of care for the procedure.
- After the transplant, participants will be monitored for up to 1 year. Any problems or side effects from the transplant will be treated as necessary. All outcomes will be reported to the National Cord Blood Program and to the Center for International Blood and Marrow Transplant.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Aplastic Anemia Leukemia Myelodysplastic Syndrome (MDS) Lymphoma | Biological: Cord Blood Units | Phase 2 |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 500 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units (CBUs) Manufactured by the National Cord Blood Program (NCBP) and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients |
| Actual Study Start Date : | October 16, 2015 |
| Estimated Primary Completion Date : | November 30, 2037 |
| Estimated Study Completion Date : | November 30, 2037 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 1
at least one
|
Biological: Cord Blood Units
cord blood units for transplants |
- safety of administration of the unlicensed investigational NCBP HPC-CORD BLOOD products [ Time Frame: 1 year post transplant ]safety
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: | 4 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
- Patients of any age or either gender with indications for receipt of investigational HPC-CORD BLOOD who are participating in an NIH-IRB approved clinical trial for unrelated hematopoietic stem cell transplantation.
- Signed informed consent (and assent when applicable).
EXCLUSION CRITERIA:
- Patients who are receiving licensed CB products (only)
- Patients who are receiving unlicensed CB products from other CB banks (i.e. NMDP)
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): NCT01861093
| Contact: Jennifer S Wilder, R.N. | (301) 451-3722 | jw621w@nih.gov | |
| Contact: Richard W Childs, M.D. | (301) 451-7128 | childsr@nhlbi.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Principal Investigator: | Richard W Childs, M.D. | National Heart, Lung, and Blood Institute (NHLBI) |
| Responsible Party: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT01861093 |
| Other Study ID Numbers: |
130116 13-H-0116 |
| First Posted: | May 23, 2013 Key Record Dates |
| Last Update Posted: | March 17, 2023 |
| Last Verified: | October 19, 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Unrelated Hematopoietic Stem Cell Transplantation Cryopreserved Cord Blood Units National Cord Blood Program |
|
Preleukemia Myelodysplastic Syndromes Anemia, Aplastic Bone Marrow Diseases Hematologic Diseases |
Precancerous Conditions Neoplasms Anemia Bone Marrow Failure Disorders |