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Recruiting
NCT02532452
Third Party Viral Specific T-cells (VSTs)
Conditions: Viral Infection, Viral Reactivation, Infection in an Immunocompromised Host
Sex: All
Ages: 2 Days – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 1000
Sponsor: Children's Hospital Medical Center, Cincinnati
Location: Akron Children's Hospital Akron Ohio
Summary
The purpose of this study is to demonstrate that viral specific T-cells (a type of white blood cell) can be generated from an unrelated donor and given safely to patients with viral infections.
Eligibility Criteria
Inclusion Criteria:
* Immunocompromised patient with evidence of viral infection or reactivation
* Age \>1 day
* Recipients who have had a stem cell transplant 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
* Must be able to receive CTL infusion in Cincinnati
* Informed consent obtained by PI or sub-investigator either in person or by phone
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
* Biopsy confirmed acute rejection of solid organ transplant OR empiric treatment of suspected but not confirmed acute rejection of solid organ transplant within the last 30 days
Source: ClinicalTrials.gov (NCT02532452). StuddyBuddy aggregates publicly available trial information.