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Search / Trial NCT02048332

Donor-Derived Viral Specific T-cells (VSTs)

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Jan 27, 2014

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Epstein Barr Virus (Ebv) Adenovirus (Adv) T Cells Donor Transplant Children Cytomegalovirus (Cmv) Bk Virus (Bkv)

ClinConnect Summary

In this clinical trial, researchers are studying a new treatment approach using specially designed immune cells called donor-derived viral specific T-cells (VSTs) to help patients who develop viral infections after receiving an allogeneic stem cell transplant. After such transplants, patients often face a weakened immune system, making them more vulnerable to viruses that can lead to serious health issues. The goal of this study is to see if these VSTs can effectively fight off viral infections, potentially providing an easier and safer alternative to current treatments, which can be expensive and have significant side effects.

To participate in the trial, patients must be at least 21 days post-transplant and stable enough to reduce steroid medications. They also need to have shown signs of recovery, such as having enough white blood cells. However, those with certain complications, like severe ongoing infections or active graft-versus-host disease (a condition where the donated cells attack the recipient's body), cannot join the study. Participants in this trial can expect to receive the VST infusion and will be monitored closely for their response to treatment. This research could pave the way for better management of viral infections in transplant recipients, offering hope for improved recovery and quality of life.

Gender

ALL

Eligibility criteria

  • 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

About Children's Hospital Medical Center, Cincinnati

Children's Hospital Medical Center in Cincinnati is a leading pediatric healthcare institution dedicated to advancing child health through innovative clinical research and comprehensive patient care. Renowned for its commitment to excellence, the center conducts a wide range of clinical trials aimed at developing and evaluating new treatments and therapies for pediatric populations. With a focus on multidisciplinary collaboration and ethical research practices, Children's Hospital Medical Center strives to improve health outcomes for children while contributing to the broader scientific understanding of pediatric medicine.

Locations

Cincinnati, Ohio, United States

Cincinnati, Ohio, United States

Akron, Ohio, United States

Cincinnati, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Michael Grimley, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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