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Cell Therapy

DCreg Infusion for Liver Transplant Recipients

Phase 1 & 2

Waitlist Available

Led By Abhinav Humar, MD

Research Sponsored by Angus W. Thomson PhD DSc

Eligibility Criteria Checklist

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

Must have

For female donors of childbearing potential, a negative urine or serum pregnancy test is required

Recipients must be between ages 18 and 65 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post-transplantation (prior to weaning) 4.5 years post transplantation

Awards & highlights

Study Summary

This trial is testing whether a single infusion of donor-derived DCreg one week before liver transplantation can help recipients wean off immunosuppression later. All patients will be kept on immunosuppression for the first six months after transplantation, at which point some may be able to start weaning off if they meet specific criteria. The trial will follow participants for three years after the last dose of immunosuppression.

Who is the study for?

This trial is for living donor liver transplant recipients aged 18-65 and donors aged 18-55, all free from hepatitis B/C, HIV, HTLV-1/2. Female participants must not be pregnant and agree to use effective contraception. Recipients should be undergoing their first liver transplant and meet standard criteria without exclusion factors.Check my eligibility

What is being tested?

The study tests a single infusion of donor-derived DCreg cells given one week before transplantation in low-risk patients. Post-transplant, they'll receive MPA and Tacrolimus for six months then may wean off MPA over another six months if eligible. After one year, some may start weaning off Tacrolimus over six more months.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but could include typical risks associated with immunosuppressive therapy such as increased infection risk, possible drug-specific reactions like kidney or liver toxicity, gastrointestinal issues or other organ-related complications.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman who can have children and have a negative pregnancy test.

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I am between 18 and 65 years old.

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I am having my first liver transplant.

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I am between 18 and 55 years old.

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I am a woman who can have children and have a negative pregnancy test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post-transplantation (prior to weaning) 4.5 years post transplantation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post-transplantation (prior to weaning) 4.5 years post transplantation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-transplantation (prior to weaning) 4.5 years post transplantation for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Preliminary Efficacy

Proportion of Safety Events

Secondary outcome measures

Change in Quality of Life

Change in cardiovascular risk factors

Change in renal function

+1 more

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Angus W. Thomson PhD DScLead Sponsor

1 Previous Clinical Trials

24 Total Patients Enrolled

University of PittsburghOTHER

1,720 Previous Clinical Trials

16,342,795 Total Patients Enrolled

Abhinav Humar, MDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

DCreg (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03164265 — Phase 1 & 2

Liver Transplant Clinical Trial 2023: DCreg Highlights & Side Effects. Trial Name: NCT03164265 — Phase 1 & 2

DCreg (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03164265 — Phase 1 & 2

Frequently Asked Questions

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

Does this clinical experiment encompass individuals aged 85 and over?

"This experiment is recruiting patients of legal age and those no older than 55 years."

Answered by AI

What criteria is necessary for a person to participate in this experiment?

"This trial seeks 16 participants, aged 18-55, who have undergone living donor liver transplants. Furthermore, these individuals must be male or female and of any race/ethnicity classified as low risk according to medical criteria."

Answered by AI

What is the ultimate goal of this investigation?

"This long-term clinical trial primarily focuses on assessing the safety of a given drug, with secondary objectives involving tracking patients' renal function, quality of life (as evaluated via a Short Form 36 questionnaire), and any changes in cardiovascular risk factors over time."

Answered by AI

Are those seeking medical treatment eligible to participate in this experiment?

"The clinicaltrials.gov page for this study indicates that it is not presently recruiting patients, having first been posted in August 2017 and last edited on September 7th 2022. Nevertheless, there are still 5 other medical trials actively registering participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DCreg in Living Donor Liver Transplantation

Angus W. Thomson PhD DSc 2017. "DCreg in Living Donor Liver Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03164265.

All > Liver Transplant