9 Participants Needed

Cellular Therapy for Liver Transplant Recipients

(LITTMUS-MGH Trial)

Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a treatment using special cells to help liver transplant patients stop taking anti-rejection drugs. It targets liver transplant recipients and aims to help their immune systems accept the new liver naturally. Recent studies have shown benefits of combining these special cells with minimal medication to promote acceptance and potentially regeneration.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on chronic immunosuppressive drugs or systemic glucocorticoids, you may not be eligible to participate.

Is cellular therapy safe for liver transplant recipients?

Research shows that cellular therapies, including mesenchymal stromal cells and regulatory T cells, have been generally safe for liver transplant patients. Studies found no significant adverse events related to these treatments, suggesting they are safe for human use in this context.12345

How is the treatment arTreg-CSB different from other treatments for liver transplant recipients?

The treatment arTreg-CSB is unique because it involves using regulatory T cells, which are a type of immune cell, to help liver transplant recipients potentially reduce or eliminate the need for long-term immunosuppressive drugs. This approach aims to induce 'operational tolerance,' allowing the body to accept the transplanted liver without ongoing medication to suppress the immune system.16789

What data supports the effectiveness of the treatment arTreg-CSB for liver transplant recipients?

Research shows that regulatory T cells (Tregs) can be expanded and used in liver transplant settings to promote transplant tolerance, even in patients with liver failure or on immunosuppressive therapy. This suggests that treatments involving Tregs, like arTreg-CSB, may help improve outcomes for liver transplant recipients.610111213

Who Is on the Research Team?

JF

James F. Markmann, MD, PhD

Principal Investigator

University of Pennsylvania Medical Center: Transplantation

Are You a Good Fit for This Trial?

This trial is for liver transplant recipients with a positive Epstein-Barr virus test, who've completed treatment for HCV if applicable. Living donors must meet specific eligibility and manufacturing requirements. Contraception use is required, and vaccinations should be up to date. Exclusions include contraindications to certain drugs, chronic conditions that can't pause anticoagulation or immunosuppression, significant heart disease not cleared by a cardiologist, high-risk malignancies, and any factors affecting study compliance.

Inclusion Criteria

Recipient:
I understand the study and can give my consent.
Agreement to use contraception
See 11 more

Exclusion Criteria

I am allergic or react badly to cyclophosphamide or Mesna.
I don't have CMV antibodies, but my donor does.
Factors potentially hampering compliance with the study protocol and follow-up visit schedule
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of Treg product (arTreg-CSB) via IV infusion

1 day
1 visit (in-person)

Immunosuppression Withdrawal

Participants attempt to withdraw from all immunosuppression over 52 weeks

52 weeks
Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including research biopsies at 52 and 104 weeks

104 weeks
Research biopsies at 52 and 104 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • arTreg-CSB
  • Cyclophosphamide
  • Everolimus
  • Mesna
Trial Overview The trial tests cellular therapy aiming to reduce the need for immunosuppression in liver transplant patients using everolimus (a drug), arTreg-CSB (modified T cells), leukapheresis (a procedure to collect white blood cells), cyclophosphamide and mesna (chemotherapy agents). It's an open-label study at MGH where participants are openly given these interventions without randomization.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: arTreg-CSBExperimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

Immune Tolerance Network (ITN)

Collaborator

Trials
68
Recruited
7,900+

Citations

[Granulocyte colony-stimulating factor-mobilized autologous bone marrow stem cells promote the liver regeneration of partial liver transplant: an experiment with rats]. [2011]
Application of liver stem cells for cell therapy. [2007]
Ex vivo generation of regulatory T cells from liver transplant recipients using costimulation blockade. [2023]
Autologous mobilized peripheral blood CD34(+) cell infusion in non-viral decompensated liver cirrhosis. [2018]
Therapeutic liver repopulation for the treatment of metabolic liver diseases. [2012]
Cell-Mediated Therapies to Facilitate Operational Tolerance in Liver Transplantation. [2021]
A pilot study of operational tolerance with a regulatory T-cell-based cell therapy in living donor liver transplantation. [2022]
Applicability, safety, and biological activity of regulatory T cell therapy in liver transplantation. [2023]
Third-party bone marrow-derived mesenchymal stromal cell infusion before liver transplantation: A randomized controlled trial. [2023]
Granulocyte colony-stimulating factor and autologous CD133-positive stem-cell therapy in liver cirrhosis (REALISTIC): an open-label, randomised, controlled phase 2 trial. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Hepatic progenitors and strategies for liver cell therapies. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Mobilization of host stem cells enables long-term liver transplant acceptance in a strongly rejecting rat strain combination. [2023]
Stem cells in liver failure. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security