Trials Sponsors Conditions Drugs Pricing

Conditions

End-stage Liver Disease

Outcome Measures

Primary Outcomes (2)

Rate of dose limiting toxicities (DLTs)
rate of adverse events qualifying as dose limiting toxicities
1 month after IMP administration
Graft Loss
Rate of cellular rejection
24 months

Secondary Outcomes (5)

Immunosuppressive doses
24 months
Prevention of acute and chronic rejection
24 months
Acute and Chronic Toxicity
24 months
Liver histology
12 months
Rate of successful immunosuppressive drug withdrawal
24 months

Other Outcomes (1)

Immunological biomarkers
12 months

Study Arms (1)

Autologous Regulatory T cell therapy

EXPERIMENTAL

Autologous regulatory T cell therapy infused intravenously (2 dose groups: low dose and high dose)

Drug: Autologous regulatory T cell product

Interventions

Autologous regulatory T cell productDrug

Autologous regulatory T cell therapy infused intravenously (2 dose groups: low dose and high dose). The patients also receive rabbit Antithymocyte Globulin (rATG), tacrolimus, and sirolimus.

Autologous Regulatory T cell therapy

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Able to give informed consent
adult patients with end-stage liver disease listed for primary liver transplant;

Sponsors & Collaborators

Guy's and St Thomas' NHS Foundation Trust
Otherlead
King's College London
Othercollaborator

Study Sites (1)

Kings College Hospital

London, United Kingdom

MeSH Terms

Conditions

End Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

Giovanna Lombardi, PhD
King's College London
STUDY DIRECTOR

Enrollment

9 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 16, 2014

First Posted

June 18, 2014

Study Start

June 2014

Date type not reported

This date has not been verified as actual or estimated.

Safety and Efficacy Study of Regulatory T Cell Therapy in Liver Transplant Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Other Outcomes (1)

Study Arms (1)

Autologous Regulatory T cell therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Other Outcomes (1)

Study Arms (1)

Autologous Regulatory T cell therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations