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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have no risk factors for Creutzfeldt-Jakob disease.
Select...
I can safely undergo a leukapheresis procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Change in Quality of Life as measured by the Short Form 36 (SF-36)
Change in cardiovascular risk factors
Change in renal function
+1 moreTrial 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.
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Who is running the clinical trial?
Angus W. Thomson PhD DScLead Sponsor
1 Previous Clinical Trials
16 Total Patients Enrolled
Abhinav HumarPrincipal InvestigatorUniversity of Pittsburgh
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had Hepatitis B or C, but it's not currently active.I haven't received any live vaccines in the last 12 weeks.My liver disease is due to PSC, autoimmune causes, or PBC.I have no risk factors for Creutzfeldt-Jakob disease.You have experienced rejection of a previous treatment within the past 2 years.I understand the study and agree to participate.I have severe heart or lung problems.I am undergoing or have undergone a second liver transplant.I am 18 years old or older.I can safely undergo a leukapheresis procedure.
Research Study Groups:
This trial has the following groups:- Group 1: DCreg Prior to Weaning
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What purpose does this experiment hope to fulfill?
"This medical experiement, which will be tracked over a 4-year period, seeks to measure the prevalence of chronic rejection among recipients. Secondary objectives include evaluating changes in Quality of Life using SF36 scores; Donor Specific Antigen (DSA) levels within four weeks after DCreg infusion; and alterations in cardiovascular risk factors such as hypertension requiring medication, post-transplant diabetes mellitus, hyperlipidemia or hypercholesterolemia assessed through yearly follow up appointments."
Answered by AI
Are there any vacancies for volunteers in this medical experiment?
"Clinicaltrials.gov reflects that this clinical trial is no longer recruiting patients. The initial posting was dated December 18th 2019 and the most recent amendment occurred on September 7th 2022. Nonetheless, 5 other trials are actively seeking participants at this time."
Answered by AI
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