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DCreg Cell Therapy for Liver Transplant Recipients

Phase 1 & 2

Waitlist Available

Led By Abhinav Humar

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

Negative health history for risk factors related to Creutzfeldt-Jakob disease

Have no contraindication to leukapheresis

Must not have

Following etiology of liver disease: Primary Sclerosing Cholangitis (PSC), autoimmune, Primary Biliary Cirrhosis (PBC)

Significant co-morbid conditions such as severe heart or lung disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to study the safety and efficacy of using donor-derived DCreg cells to wean living donor liver transplant recipients off immunosuppression.

Who is the study for?

This trial is for low-risk liver transplant recipients who are 1-3 years post-transplant without recent rejection or significant fibrosis. They must have stable liver function and no severe other diseases. Donors must be healthy, able to consent, and free from certain infections like HIV or hepatitis.

What is being tested?

The study tests a single infusion of donor-derived DCreg cells in patients after living donor liver transplantation. It aims to see if these cells can allow safe reduction of immunosuppression drugs over time with follow-up biopsies at one and three years post-weaning.

What are the potential side effects?

Potential side effects aren't specified but may include reactions related to the infusion process, changes in immune system activity leading to organ inflammation or increased susceptibility to infections due to reduced immunosuppression.

Eligibility Criteria

Inclusion Criteria

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

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I have no risk factors for Creutzfeldt-Jakob disease.

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I can safely undergo a leukapheresis procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver disease is due to PSC, autoimmune causes, or PBC.

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I have severe heart or lung problems.

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I am undergoing or have undergone a second liver transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Preliminary Efficacy of using DCreg therapy to facilitate immunosuppression weaning

The proportion of recipients who die

The proportion of recipients who experience CTCAE Grade 4 or higher infection

+6 more

Secondary study objectives

Change in Quality of Life as measured by the Short Form 36 (SF-36)

Change in cardiovascular risk factors

Change in renal function

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: DCreg Prior to WeaningExperimental Treatment1 Intervention

Regulatory dendritic cells that were derived from the recipient's liver donor will be infused into the recipient one week prior to the initiation of immunosuppression weaning.

0 / 5Eligibility criteria met