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Donor-Derived Viral Specific T-cells (VSTs)

RECRUITINGPhase 1/2Sponsored by Children's Hospital Medical Center, Cincinnati
Actively Recruiting
PhasePhase 1/2
SponsorChildren's Hospital Medical Center, Cincinnati
Started2014-02-05
Est. completion2027-01
Eligibility
Age4 Weeks+
Healthy vol.Accepted
Locations3 sites

Summary

In this research study, the investigators want to learn more about the use of donor-derived viral specific T-cells (VSTs) to treat viral infections that occur after allogeneic stem cell transplant. A viral specific T cell is a T lymphocyte (a type of white blood cell) that kills cells that are infected (particularly with viruses). Allogeneic means the stem cells come from another person. These VSTs are cells specially designed to fight the virus infections that can happen after a bone marrow transplant. The investigators are asking people who have undergone or will undergo an allogeneic stem cell transplant to enroll in this research study, because viral infections are a common problem after allogeneic stem cell transplant and can cause significant complications including death. Stem cell transplant reduces a person's ability to fight infections. There is an increased risk of getting new viral infections or reactivation of viral infections that the patient has had in the past, such as cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus (ADV), BK virus (BKV), and JC virus. There are anti-viral medicines available to treat these infections, though not all patients will respond to the standard treatments. Moreover, treatment of viral infections is expensive and time consuming, with families often administering prolonged treatments with intravenous anti-viral medications, or patients requiring prolonged admissions to the hospital. The medicines can also have side effects like damage to the kidneys or reduction in the blood counts, so in this study the investigators are trying to find an easier way to treat these infections.

Eligibility

Age: 4 Weeks+Healthy volunteers accepted
Inclusion Criteria:

* Recipient must be at least 21 days after stem cell infusion
* Clinical status must allow tapering of steroids to 0.5mg/kg prednisone or other steroid equivalent
* Recipient must have achieved engraftment with ANC ≥ 500

Exclusion Criteria:

* Active acute GVHD grades II-IV
* Uncontrolled bacterial or fungal infection
* Uncontrolled relapse of malignancy requiring treatment with chemotherapy
* Infusion of ATG or alemtuzumab within 2 weeks of VST infusion

Conditions4

Allogeneic Stem Cell TransplantCancerViral InfectionViral Reactivation

Locations3 sites

Akron Children's Hospital
Akron, Ohio, 44308
Courtney Culbertson, CNP330-543-3338cculbertson@akronchildrens.org
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Jamie Wilhelm513-803-1102Jamie.Wilhelm@cchmc.org

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