AuToDeCRA
Research type
Research Study
Full title
Autologous Tolerogenic Dendritic Cells for Rheumatoid and Inflammatory Arthritis
IRAS ID
50785
Contact name
John Isaacs
Contact email
Sponsor organisation
The Newcastle-upon-Tyne Hospitals NHS Foundation Trust
Eudract number
2011-001582-41
ISRCTN Number
ISRCTN87426082
Duration of Study in the UK
6 years, 3 months, 31 days
Research summary
This is an experimental medicine extension to our current phase I study which aims to look at cell migration of a new cellular therapy called autologous tolerogenic dendritic cells (TolDC), derived from patients’ own blood cells. These are labelled with 111Indium (a radioactive dye) and injected into the knees of inflammatory arthritis (IA) patients using a procedure called an arthroscopy (camera examination of the knee joint) or an ultrasound (jelly scan) guided injection. We will look to see if the cells move from the knee joint and where they go using a scan of the knee, groin and spleen at between 1 and 4 hrs, between 20 and 24 hrs and at 72 hrs after the TolDC are injected. We will use planar imaging and SPECT-CT at the latter two timepoints and planar imaging with the option of SPECT-CT at the initial timepoint. SPECT-CT may include the groins and/or knees at each timepoint. We will also look to see if the cells have any effect on disease activity (if it can help IA) and whether it can affect the immune system, as well as collecting information on safety. We will treat a maximum of 3 patients with 10 x 106 TolDC. This was the highest dose of unlabelled TolDC that we safely administered in the main part of the study.
This is a Phase 1 study in 15 subjects – 12 of which had no radiation/imaging study, and three are to have imaging. One participant in the extension has completed the study. This application is for two remaining patients to be recruited who will have modified imaging and risk estimates based on initial experience. ARSAC approval was previously given for the one participant.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
11/NE/0140
Date of REC Opinion
23 Aug 2011
REC opinion
Further Information Favourable Opinion