Actively Recruiting
Umbilical Cord Blood Transplantation From Unrelated Donors to Treat Blood and Immune Disorders
Led by University of Rochester · Updated on 2025-10-10
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the process and outcomes of umbilical cord blood stem cell transplantation from unrelated donors in patients with various blood and immune disorders. The study aims to measure how long it takes for blood cell counts to recover after transplant, how often the transplanted cells fail to engraft, and the rates of disease-free survival, relapse, and graft-versus-host disease (GvHD). GvHD is a condition where transplanted white blood cells attack the recipient's body. This observational study collects data on patients receiving standard conditioning treatments before transplantation. Participants receive different conditioning treatments based on their medical needs, including full intensity total body irradiation (TBI) with chemotherapy, full intensity chemotherapy alone, reduced intensity chemotherapy, or non-myeloablative conditioning combining chemotherapy and low-dose TBI. Following conditioning, patients undergo an intravenous infusion of umbilical cord blood stem cells. The specific conditioning regimens vary in drugs and radiation doses, given over several days before the transplant. During the study, medical records are reviewed to monitor engraftment of white blood cells and platelets up to 42 days after transplantation. Researchers track non-engraftment, graft failure, acute and chronic GvHD, disease-free survival, and relapse rates for up to 10 years after transplant. Patients are assessed at regular intervals of 30 days, 100 days, 6 months, and yearly thereafter. The study continues to collect data on these outcomes and overall survival as part of long-term follow-up.
CONDITIONS
Brief Title
Umbilical Cord Blood Transplantation From Unrelated Donors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have a disease or syndrome treatable with hematopoietic stem cell transplantation
- Diagnoses may include immunodeficiency disorders, congenital hematopoietic defects, metabolic disorders, severe aplastic anemia, high-risk leukemia, myelodysplastic syndromes, lymphoma, multiple myeloma, or certain solid tumors
- Adequate organ function including cardiac, pulmonary, renal, and hepatic criteria as specified
- Karnofsky or Lansky performance score of 70% or higher
- Informed consent must be obtained before starting conditioning therapy
- Receipt of viable cord blood product(s) confirmed before conditioning therapy
You will not qualify if you...
- Availability of a 10/10 or 9/10 HLA-matched donor within a reasonable time
- Autologous hematopoietic stem cell transplant within 6 months before planned cord blood transplant
- Pregnant or breastfeeding
- Current uncontrolled infection
- Evidence of HIV infection or positive HIV serology
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 to 2 weeks before transplantation
Participants undergo a conditioning regimen per standard of care at the discretion of the treating provider before transplantation.
Multiple visits depending on conditioning type
Duration - 1 day
Participants receive an intravenous infusion of umbilical cord blood stem cells.
1 visit (in-person)
Duration - Up to 120 months
Participants are monitored for engraftment, graft failure, graft-versus-host disease, and survival outcomes.
Visits at 30 days, 42 days, 100 days, 6 months, and yearly thereafter
Trial Site Locations
Total: 1 location
1
Wilmot Cancer Institute
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
O
Omar Aljitawi, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here