Viral Specific T-cells for Treatment of Viral Infections After Solid Organ Transplant

Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Recruiting ID
Hoxworth Blood Center (Other)

Study Details

Study Description

Brief Summary

The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to treat viral infections that may happen after solid organ transplant (SOT). VSTs are cells specially designed to fight viral infections that may happen after a solid organ transplant. These cells are created from a blood sample collected from the study participant.

Solid organ transplant and the use of immunosuppressive medications reduces the body's ability to fight infections. Viral infections are a common problem after transplant and can cause significant complications. Reduction of immunosuppression may put the organ at risk of rejection. 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 a better way to treat these infections and minimize complications.

Condition or Disease Intervention/Treatment Phase
  • Biological: Viral Specific T-cells (VSTs)
Phase 2

Study Design

Study Type:
Anticipated Enrollment :
100 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Viral Specific T-cells (VSTs) for Treatment of Viral Infections After Solid Organ Transplant
Actual Study Start Date :
Aug 18, 2020
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Viral Specific T-cells (VSTs)

Biological: Viral Specific T-cells (VSTs)
VSTs will be infused into solid organ transplant recipients who have evidence of viral infection.

Outcome Measures

Primary Outcome Measures

  1. Successful production of viral specific T-cells [Within 30 days post culture initiation]

    Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.

Secondary Outcome Measures

  1. Presence of viral-specific T-cells [At 30 days after infusion]

    Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay

Eligibility Criteria


Ages Eligible for Study:
1 Day and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Blood adenovirus PCR ≥1,000

  • Blood CMV PCR ≥ 500

  • Blood EBV PCR ≥ 1,000

  • Plasma BKV PCR >1,000

  • Plasma JC Virus PCR > 1,000

  • Evidence of invasive adenovirus infection. Adenovirus infection will be defined as the presence of adenoviral positivity as detected by PCR or culture from one site such as stool or blood or urine or nasopharynx. Adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture or PCR from more than 2 sites such as stool or blood or urine or nasopharynx.

  • Evidence of invasive CMV infection, e.g. pneumonitis, retinitis, colitis.

  • Evidence of EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation.

  • Evidence of symptomatic BK virus infection, which may include symptomatic hemorrhagic cystitis, BK viruria or BK nephropathy

  • Evidence of PML or other CNS infection due to JC virus

  • Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other steroid equivalent, or a clinically acceptable steroid dose at the discretion of the PI

  • Age > 1 day

  • Must be able to receive VST infusion in Cincinnati

Exclusion Criteria:
  • Uncontrolled bacterial or fungal infection

Contacts and Locations


Site City State Country Postal Code
1 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229

Sponsors and Collaborators

  • Children's Hospital Medical Center, Cincinnati
  • Hoxworth Blood Center


  • Principal Investigator: Stella Davies, MBBS, PhD, MRCP, Children's Hospital Medical Center, Cincinnati

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Children's Hospital Medical Center, Cincinnati Identifier:
Other Study ID Numbers:
  • 2020-0042
First Posted:
Apr 2, 2020
Last Update Posted:
Apr 8, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2022