Cord Blood Transplant for Blood Cancers and Diseases
Trial Summary
What is the purpose of this trial?
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....
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Cord Blood Transplant for Blood Cancers and Diseases?
Research shows that omidubicel, a treatment derived from umbilical cord blood, leads to faster recovery of blood cells, fewer infections, and shorter hospital stays compared to standard cord blood transplants. It has also been associated with better long-term survival rates and improved quality of life for patients with blood cancers.12345
Is cord blood transplant generally safe for humans?
Cord blood transplant using omidubicel has shown to be generally safe in humans, with faster recovery and fewer infections compared to standard cord blood transplants. Long-term follow-up studies indicate stable blood cell production and immune function, with low rates of complications like secondary graft failure.13456
How is the cord blood transplant treatment Omidubicel different from other treatments for blood cancers and diseases?
Omidubicel is unique because it is a modified stem cell product derived from umbilical cord blood that has been expanded outside the body to increase the number of stem cells. This results in faster recovery of blood cells and fewer infections compared to traditional cord blood transplants, making it a promising option for patients without a matched donor.13478
Research Team
Richard W Childs, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria
This trial is for pediatric and adult patients of any age with blood cancers or diseases affecting the bone marrow, like Myelodysplastic Syndrome or Aplastic Anemia. Participants must need a cord blood transplant and match with unlicensed cord blood units that meet NMDP standards but not current FDA standards.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-transplant Conditioning
Pre-transplant conditioning and GVHD prophylaxis as per each transplant center's specification
Transplantation
Participants receive cord blood transplant with unlicensed CBU
Post-transplant Monitoring
Monitoring for neutrophil recovery, graft rejection, infection transmission, and GVHD
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cord Blood Transplant
Cord Blood Transplant is already approved in United States for the following indications:
- Hematologic malignancies scheduled for umbilical cord transplantation following myeloablative conditioning
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor