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Cell Therapy

arTreg for Liver Transplant (LITTMUS-UCSF Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-transplant through completion of study participation (up to 4.5 years)
Awards & highlights

LITTMUS-UCSF Trial Summary

This trial is exploring whether a cell therapy can help people with liver transplants stop taking immunosuppressive drugs.

LITTMUS-UCSF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-transplant through completion of study participation (up to 4.5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-transplant through completion of study participation (up to 4.5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number and Severity of Adverse Events (AEs) Attributed to Supportive Regimen: Leukapheresis, Cyclophosphamide or Mesna
Investigational New Drugs
Number of Operationally Tolerant Participants
Secondary outcome measures
Duration of Operational Tolerance
Incidence of ≥Grade 3 Infections Following arTreg Infusion
Number of Biopsy-Proven Acute Rejection (AR) and/or Clinical Rejection Events at any Time after Alloantigen-Reactive Tregs (arTreg) Infusion
+4 more

LITTMUS-UCSF Trial Design

1Treatment groups
Experimental Treatment
Group I: arTregExperimental Treatment5 Interventions
arTreg: alloantigen-reactive T regulatory cells The investigational product is donor alloantigen-reactive regulatory T cells (arTreg). Supportive regimen for receipt of arTregs includes everolimus, leukapheresis, cyclophosphamide, and mesna. Note: Participants who receive at least the minimum Treg product (arTreg) dose of 30 to <90 x10^6 total cells will be included in intent-to-treat analysis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
leukapheresis
2004
Completed Phase 3
~230
Everolimus
FDA approved
Coenzyme M
FDA approved

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,439 Total Patients Enrolled
Rho Federal Systems Division, Inc.Industry Sponsor
41 Previous Clinical Trials
13,579 Total Patients Enrolled
PPDIndustry Sponsor
159 Previous Clinical Trials
36,885 Total Patients Enrolled

Frequently Asked Questions

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

How many participants can be enrolled in this study?

"Affirmative. Clinicaltrials.gov's information implies that this experiment is actively seeking participants, with the original post dated April 22nd 2021 and last edited on September 13th 2022. The investigators are in pursuit of 9 individuals from 1 clinical centre to participate in the trial."

Answered by AI

What conditions have been ameliorated through the use of arTreg?

"Patients suffering from multiple sclerosis, leukemia, myelocytic acute and transplant rejection can benefit from arTreg therapy. Additionally, this treatment is applicable to those with kidney conditions."

Answered by AI

Is enrollment currently open for this experiment?

"According to clinicaltrials.gov, enrolment for this medical trial is open and ongoing. It was initially published on April 22nd 2021 and revised most recently on September 13th 2022."

Answered by AI

What are the main aims of this clinical experiment?

"PPD, the study sponsor of this clinical trial, has reported that its primary measure for success is the Number and Severity of Adverse Events (AEs) Attributed to arTreg. Secondary metrics include incidents of Chronic Rejection Events at any time after Alloantigen-Reactive Tregs infusion, Number of Participants who Develop a Malignancy and Incidence of ≥Grade 3 Infections Following arTreg Infusion. These outcomes will be evaluated over an observation period spanning 52 weeks (+/- 4)."

Answered by AI

Does the eligibility for this clinical experiment encompass those aged 65 and above?

"The inclusionary standards of this trial necessitate that participants must fall within the 18-70 age bracket. For individuals younger than 18, there are 306 studies available; for those over 65, 749 studies exist."

Answered by AI

Has arTreg been researched in other contexts?

"Presently, there are 909 research projects centred around arTreg. This includes 170 trials in their third stage of development. While Philadelphia is the hub for studies surrounding this treatment, it has also been trialled at 31859 other locations globally."

Answered by AI

Am I eligible to partake in this clinical trial?

"This medical trial is searching for nine individuals with a history of liver transplantation in the age range 18-70. Essential criteria include an understanding and agreement to give informed consent, being listed as either a living or deceased donor candidate for primary solitary liver transplatnation, contraception use when applicable, sustained viral response from hepatitis c treatment over 24 weeks prior to transplant if HCV positive, immunizations up-to-date based on ACIP recommendations unless deemed unnecessary by investigator; meeting eligibility requirements specific to the clinical site they are donating at; commitment to provide biologic samples; and fulfilling further site-specific clinical donor requisites."

Answered by AI
~7 spots leftby Apr 2025