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Virus Therapy

VST Infusion for Post-Transplant Viral Infections (VSTs Trial)

Phase 1 & 2

Recruiting

Led By Michael Grimley, MD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 30 days after infusion

Awards & highlights

VSTs Trial Summary

This trial is for people who have undergone or will undergo an allogeneic stem cell transplant. The investigators are testing whether VSTs can help reduce the risk of viral infections or help treat viral infections that occur after transplant.

Who is the study for?

This trial is for people who've had or will have a stem cell transplant from another person and are struggling with viral infections post-transplant. They must have stable white blood cell counts, be able to reduce steroid use, and be at least 21 days past their stem cell infusion. It's not for those recently treated with certain immune suppressants, experiencing severe graft-versus-host disease, uncontrolled bacterial/fungal infections, or cancer relapse.Check my eligibility

What is being tested?

The study tests the effectiveness of infusing donor-derived T-cells that specifically target viruses in patients after allogeneic stem cell transplants. These special cells aim to combat common but potentially deadly viral infections that can occur when someone's immune system is weakened by a transplant.See study design

What are the potential side effects?

While specific side effects aren't listed here, similar treatments may cause reactions at the infusion site, flu-like symptoms, fatigue, risk of other infections due to immune response changes and potential complications related to how these cells interact with existing medications or conditions.

VSTs Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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It has been at least 21 days since my stem cell infusion.

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I can reduce my steroid use to a low dose.

VSTs Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 days post culture initiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 days post culture initiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days post culture initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of GVHD associated with VST infusion

Percentage of patients who do not have infusional toxicity

Successful production of viral specific T-cells

Secondary outcome measures

Presence of viral-specific T-cells

Viral burden

VSTs Trial Design

1Treatment groups

Experimental Treatment

Group I: Viral Specific VST InfusionExperimental Treatment1 Intervention

Viral reactivation or infection. VST Reinfusion required.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,141 Total Patients Enrolled

5 Trials studying Viral Infections

1,002 Patients Enrolled for Viral Infections

Hoxworth Blood CenterOTHER

6 Previous Clinical Trials

873 Total Patients Enrolled

4 Trials studying Viral Infections

252 Patients Enrolled for Viral Infections

Michael Grimley, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

1 Previous Clinical Trials

30 Total Patients Enrolled

1 Trials studying Viral Infections

30 Patients Enrolled for Viral Infections

Media Library

Viral specific VST Infusion (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02048332 — Phase 1 & 2

Viral Infections Research Study Groups: Viral Specific VST Infusion

Viral Infections Clinical Trial 2023: Viral specific VST Infusion Highlights & Side Effects. Trial Name: NCT02048332 — Phase 1 & 2

Viral specific VST Infusion (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02048332 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research subjects are included in the data set?

"That is correct, the clinical trial mentioned is actively recruiting patients as of today. The first posting was on February 5th, 2014 with the most recent update being August 15th, 2022. A total of 450 individuals are needed for this study taking place at 1 location."

Answered by AI

Are we still enrolling patients for this opportunity?

"Yes, this study is still looking for patients. The clinicaltrials.gov posting indicates that the first notice was on February 5th, 2014 and the most recent update was on August 15th, 2022."

Answered by AI

Recent research and studies

Blood AdvancesJournal

Virus-specific T Cells for Adenovirus Infection After Stem Cell Transplantation Are Highly Effective and Class II HLA Restricted

Rubinstein, Jeremy D., Xiang Zhu, Thomas Leemhuis, Giang Pham, Lorraine Ray, Sana Emberesh, Sonata Jodele, et al.. 2021. “Virus-specific T Cells for Adenovirus Infection After Stem Cell Transplantation Are Highly Effective and Class II HLA Restricted”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2021004456.

clinicaltrials.govStudy

Donor-Derived Viral Specific T-cells (VSTs)

2014. "Donor-Derived Viral Specific T-cells (VSTs)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02048332.

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