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Virus Therapy

T-cell Therapy for Viral Infections

Q: How many individuals can participate in this clinical experiment?

Affirmative. According to clinicaltrials.gov, this research project is still searching for participants and was initially shared on September 2nd 2015. There are 450 positions open at a single site that need to be filled by April 7th 2022.

Q: Are there any openings left for individuals to participate in this clinical investigation?

Affirmative. According to the information furnished on clinicaltrials.gov, this investigation is actively seeking enrollees since its initial posting in September 2015 and most recent update in April 2022. 450 participants are sought at a single medical centre.

Q: To what extent has the FDA endorsed Viral Specific VST Infusion?

The team at Power believes that the Viral Specific VST Infusion is moderately safe and gave it a score of 2. This conclusion was drawn from Phase 2 trials, which have yielded some evidence supporting its safety but no data to attest to its efficacy.

Phase 2

Recruiting

Led By Michael Grimley, MD, 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

Age >1 day

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

Study Summary

This trial will show that it's safe to give patients with viral infections T-cells from an unrelated donor.

Who is the study for?

This trial is for immunocompromised patients of any age with viral infections, especially those who've had a stem cell transplant at least 21 days prior. Participants must be able to reduce steroid use and travel to Cincinnati for the infusion. It's not suitable for individuals with active acute GVHD grades II-IV, uncontrolled bacterial/fungal infections, cancer relapse, or recent ATG/alemtuzumab infusions.Check my eligibility

What is being tested?

The study tests if T-cells from an unrelated donor can safely treat viral infections in immunocompromised patients. These special white blood cells are designed to fight specific viruses and will be infused into participants to see if they help control the infection.See study design

What are the potential side effects?

While specific side effects aren't listed here, similar treatments often involve risks like immune reactions where the body attacks its own cells, infusion-related reactions such as fever or chills, and potential worsening of underlying conditions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am older than 1 day.

Select...

I can reduce my steroid use to less than 0.5mg/kg.

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Viral Specific VST InfusionExperimental Treatment1 Intervention

3rd party VST infusion

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,530,841 Total Patients Enrolled

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

Media Library

Viral Specific T-cells (VSTs) (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02532452 — Phase 2

Host Infection Research Study Groups: Viral Specific VST Infusion

Host Infection Clinical Trial 2023: Viral Specific T-cells (VSTs) Highlights & Side Effects. Trial Name: NCT02532452 — Phase 2

Viral Specific T-cells (VSTs) (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02532452 — Phase 2

Frequently Asked Questions

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

How many individuals can participate in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this research project is still searching for participants and was initially shared on September 2nd 2015. There are 450 positions open at a single site that need to be filled by April 7th 2022."

Answered by AI

Are there any openings left for individuals to participate in this clinical investigation?

"Affirmative. According to the information furnished on clinicaltrials.gov, this investigation is actively seeking enrollees since its initial posting in September 2015 and most recent update in April 2022. 450 participants are sought at a single medical centre."

Answered by AI

To what extent has the FDA endorsed Viral Specific VST Infusion?

"The team at Power believes that the Viral Specific VST Infusion is moderately safe and gave it a score of 2. This conclusion was drawn from Phase 2 trials, which have yielded some evidence supporting its safety but no data to attest to its efficacy."

Answered by AI