Rheumatoid Arthritis Clinical Trial
Official title:
Phase 1 Clinical Trial to Evaluate the Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis
The purpose of phase 1 clinical trial is to to evaluate safety in subjects with moderate to severe rheumatoid arthritis after infusion.
Rheumatoid arthritis(RA) is a chronic and progressive autoimmune disease characterized by
synovial hyperplasia and joint damage leading to clinically significant functional
impairment. In RA, for some unknown reason, immune cells infiltrate into synovium of joint
and produce the 'rheumatoid factor', prostaglandins, cytokines and other mediators. It
damages joint and cartilage, even other organs. 80% of the RA patients have Rheumatoid
factor which is caused by high expression ratio of auto-antibodies in blood. Produced immune
complexes, immune cells and antigen-presenting cells(including macrophages, B cells,
dendritic cells) activate and release cytokines and then synovial tissue becomes thickened
and damaged.
It has been reported that synthetic DMARDs(disease-modifying antirheumatic drugs) including
methotrexate(MTX), sulfasalazine and biological DMARDs such as tumor necrosis factors(TNF)-α
blockers, abatacept and rituximab, often in combination with MTX, are effective. But they
still are limited by lack or loss of efficacy in certain patients and serious complications
such as serious infections and malignancies. So, there is a need to identify new treatment.
FURESTEM-RA Inj. is composed of allogeneic hUCB-MSC(human Umbilical Cord Blood
derived-Mesenchymal Stem cell). hUCB-MSCs are mesenchymal stem cells from umbilical cord
blood. Mesenchymal stem cells are well-known for immunosuppression, anti-inflammatory
ability and capable of differentiating into a wide range of cell types including osteocytes
and chondrocytes. Therefore, FURESTEM-RA Inj. has huge possibility as cell therapy products
for RA patients.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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