Autologous Tolerogenic Dendritic Cells for Rheumatoid Arthritis (AutoDECRA)
Status:
Unknown status
Trial end date:
2019-04-01
Target enrollment:
Participant gender:
Summary
This is a study which will look at safety, feasibility and acceptability of a new therapy
called tolerogenic dendritic cells (TolDC), derived from the patient's own white blood cells,
which will be injected into the knee joints of rheumatoid arthritis patients, using a
procedure called arthroscopy (a camera examination of a joint). The investigators are also
looking to see if the drug has any effect on the disease activity (if it can help in RA) and
whether the drug can affect the immune system. The investigators aim to treat 12 patients in
total, 9 with TolDC and 3 with a control treatment. Three doses of TolDC will be tested, 3
patients per dose. Subjects will have RA and at least one swollen knee joint. They will
undergo a knee ultrasound scan, fill in a series of questionnaires, have their knee aspirated
(fluid taken out) and finally undergo a procedure called leukapheresis (removal of white
blood cells) from which the treatment will be manufactured. Subsequently they will undergo 3
arthroscopies (camera examination of the knee joint) over a period of about 12 weeks. On the
first arthroscopy they will have the TolDC injected into their knee joint. They will then
spend the night at the Clinical Research facility for observation. Over the next 5 days they
will be telephoned daily by the study doctor to check how they are, and will be reassessed if
needed. About 2 weeks later they will have their second arthroscopy to look for effects of
treatment, and the third will take place at 13 weeks (end of study) or sooner if the knee
appears to get worse.
Phase:
Phase 1
Details
Lead Sponsor:
Newcastle University
Collaborators:
Arthritis Research UK Newcastle-upon-Tyne Hospitals NHS Trust