NCT01352858

Autologous Tolerogenic Dendritic Cells for Rheumatoid Arthritis (AutoDECRA)

Phase 1 Study of Autologous Tolerogenic Dendritic Cells for Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Newcastle University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	TolDC	Tolerogenic dendritic cells (TolDC), derived ex vivo from autologous monocytes, administered arthroscopically into an inflamed knee following saline irrigation.
DRUG	Arthroscopy & saline irrigation alone

Timeline

• Start date: 2012-02-01
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2011-05-12
• Last updated: 2023-11-30

Locations

1 site across 1 country: United Kingdom