GMP Validation of TolDC
Research type
Research Study
Full title
Collection of White Blood Cells [Using Leukapheresis] from Rheumatoid Arthritis Patient's for the Validation of an Advanced Treatment for Rheumatoid Arthritis (TolDC)
IRAS ID
276044
Contact name
John Isaacs
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
This research study is about obtaining white blood cells using a routine procedure, leukapheresis, in order to produce a new treatment for Rheumatoid Arthritis (RA); tolerogenic dendritic cells (tolDC). Therapy with tolDC has great potential for the treatment of conditions caused by problems with the immune system, such as RA.
In autoimmune diseases such as RA, the immune system has become confused and attacks normal tissues. We believe that tolDC treatment, which we have developed, can 'switch off' the confused immune system in RA. In our recently completed phase I study of tolDCs (AuToDeCRA) we used RA patient blood samples to make tolDCs which were mixed with joint fluid (synovial fluid) from the patient before being injected back into the patients inflamed joint. AuToDeCRA showed that tolDC treatment is safe.
We are now preparing to carry out another clinical trial to test the best administration route of tolDC and look any effects the treatment has on the immune system in RA patients. Before carrying the clinical trial we need to adapt the way tolDCs are made so that they can be followed in the body. We need to demonstrate that the manufacturing process for the altered tolDC therapy is tested (validated) and ensure that it is at clinical grade standard before use in patients.
It is not feasible to obtain the quantity of white blood cells needed to make clinical grade tolDC from routine blood donations, however leukapheresis products contain a large number of monocytes and is the process we are going to use in this study. Six participants with RA will be recruited to donate white blood cells by leukapheresis as part of this study. Participants in this part of the study will not receive treatment with the tolDC product. This study concerns the validation of the manufacturing process only.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
20/YH/0203
Date of REC Opinion
22 Jul 2020
REC opinion
Favourable Opinion