AUTUMN: AUtologous T-regulatory cell tracking after InfUsion in AutoiMmuNe Liver Disease patients

 Chief Investigator:
 Dr Ye Htun Oo
 Sponsor:  University of Birmingham
 Funder:  Medical Research Council
Disease Site:   Non-cancer; Auto-immune Hepatits
 Trial Type:   Phase 0, proof-of-concept, non-IMP study
 Status:  Open
 UKCRN Study ID (if applicable):  N/A
 ISRCTN Referance Number:  N/A
 Open to New Sites?  No
 Recruitment Start Date: 07-Jul-2016
 Recruitment End Date:  
 CRCTU Trial Management Team: D3B Team
 Trial Email Address:

In autoimmune diseases the immune system mistakenly recognises parts of the body as foreign objects and begins to attack itself. This leads to tissue damage in the affected body part/s. T cells are the immune cells that carry out this attack as they fail to identify the body as a part of itself. In autoimmune hepatitis (AIH), liver cells (known as hepatocytes) are attacked by the T cells, causing liver inflammation. In recent years it has been found that the tissue damage caused by these T cells could be controlled by anti-inflammatory regulatory T cells (Tregs). These Treg cells could potentially be made from the patient’s own blood and used for their treatment in autoimmune hepatitis.

As a result, the AUTUMN study will be investigating how Tregs function in this condition by labelling them with a radioactive substance called Indium-111 which will allow the movement of these cells to be tracked using nuclear imaging scans. This will increase the understanding of how these immune cells work which may allow for therapeutic use of Treg cells in autoimmune hepatitis in the future.        

AUTUMN opened in July 2016 and will recruit 4 patients with AIH.

Please note that the trials team cannot give individual’s clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible

Trial Summary

Trial Protocol

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