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Third Party Viral Specific T-cells (VSTs)

RECRUITINGPhase 2Sponsored by Children's Hospital Medical Center, Cincinnati
Actively Recruiting
PhasePhase 2
SponsorChildren's Hospital Medical Center, Cincinnati
Started2015-09-02
Est. completion2026-12
Eligibility
Age2 Days+
Healthy vol.Accepted
Locations4 sites
View on ClinicalTrials.gov →

NCT02532452

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

Age: 2 Days+Healthy volunteers accepted
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

Conditions4

CancerInfection in an Immunocompromised HostViral InfectionViral Reactivation

Locations4 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
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus, Ohio, 43210
Nicole Szuminski, MS, RN, CCRCnicole.szuminski@osumc.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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