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: |
autumn@trials.bham.ac.uk |
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
- View Trial Protocol Document
Please Note:
Clinical trial protocols are complex technical documents which should only be used for the treatment of subjects taking part in the trial. Patients who are interested in taking part in the trial are advised to talk to their health care professional.
Investigators please ensure you have R&D approval for this specific version of the protocol before using as a reference.