Actively Recruiting
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-12-16
750
Participants Needed
3
Research Sites
N/A
Total Duration
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
H
Hoxworth Blood Center
Collaborating Sponsor
This research investigates the use of donor-derived viral specific T-cells (VSTs) to treat viral infections occurring after allogeneic stem cell transplant. Viral infections such as cytomegalovirus, Epstein-Barr virus, adenovirus, BK virus, and JC virus are common complications following transplant and can cause serious health issues. The study aims to find an easier and potentially safer way to manage these infections, which currently require prolonged and sometimes toxic antiviral treatments. The donor who matches the stem cell transplant recipient will provide a blood sample to create the VSTs in the lab. These cells are grown and stored in a freezer until needed. If the patient shows signs of viral infection after transplant, they may receive up to five infusions of these virus-fighting cells spaced 14 to 21 days apart. The cells are given to help the patient's immune system fight the virus, and more infusions may be given based on the patient's response. During the study, patients will be closely monitored with physical exams and blood tests both in the hospital and outpatient settings. Blood and urine samples will be collected before each infusion and regularly for up to a year after the final infusion. Researchers will assess how well the VSTs are produced, any infusion-related side effects, and the presence of viral infections. The goal is to evaluate the safety and viral response to this treatment over time.
CONDITIONS
Donor-Derived Viral Specific T-cells (VSTs)
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants must be at least 21 days post stem cell transplant and meet clinical criteria before enrollment.
Duration - Up to 5 infusions with 14 to 21 days between each
Participants receive viral specific T-cell infusions if they have evidence of viral infection after their transplant. They may receive up to 5 infusions spaced 14 to 21 days apart depending on viral response.
1 infusion visit plus blood and urine collection before each infusion
Duration - Weekly for 4 weeks, then monthly for up to 1 year after last infusion
Participants are monitored after their last infusion with physical exams and blood tests to assess viral response and safety.
Weekly visits for 4 weeks then monthly visits for up to 1 year
Total: 3 locations
1
Akron Children's Hospital
Akron, Ohio, United States, 44308
Actively Recruiting
2
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Completed
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
J
Jamie Wilhelm, BS
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/34473237