Status:
COMPLETED
Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis(RA)
Lead Sponsor:
Kang Stem Biotech Co., Ltd.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
19-80 years
Phase:
PHASE1
Brief Summary
The purpose of phase 1 clinical trial is to to evaluate safety in subjects with moderate to severe rheumatoid arthritis after infusion.
Detailed Description
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...
Eligibility Criteria
Inclusion
- of either gender, 19-80years old
- Subjects must be diagnosed with ACR functional class I. II, III Rheumatoid Arthritis according to the 2010 ACR/EULAR criteria for at least 12 weeks duration.
- Subjects must be taking DMARDs or NSAIDs including methotrexate, sulfasalazine, hydroxychloroquine, leflunomide of stable dose within 12 weeks before screening visit and be willing to remain on stable dose throughout the study
- If subject is currently administering steroids everyday, when steroid dose is converted into prednisolone oral dose, the subject should take a stable dose(≤10mg/day) over 4 weeks on screening visit
- Subject who has moderate to severe disease activity (DAS28-ESR\>3.2) on screening visit
- Subject who understands and voluntarily sign an informed consent form
Exclusion
- Subjects who is diagnosed ACR function class IV Rheumatoid Arthritis
- Subjects who has cardiovascular disorders, blood dyscrasia, AIDS(Acquired Immune Deficiency Syndrome), other rheumatic disease(Crohn's disease, systemic lupus erythematosus, lyme disease, psoriatic arthritis, spondylarthropathy, infectious or reactive arthritis, reiter's syndrome, etc.)
- subject who has administered the following biological DMARDs
- subject who has administered more than 1 drugs(Infliximab, Adalimumab, Etanercept, Anakinra, Abatacept) within 6 months before screening visit
- subject who has administered Rituximab within 1 year before screening visit
- Subject who has history of hypersensitivity, heavy metal poisoning, etc. to drugs which is composed of similar components.
- Subject who has treated intra-articular steroid injection within 4 weeks before screening visit
- Subject who has administered ACTH(adrenocorticotropic hormone) agents within 4 weeks before screening visit
- Subject who has undergone administration of any investigational drug within 30 days before screening visit.
- Subject who has diseases or takes medicine which are prohibited prescription of NSAIDs.
- Subject who needs to take the medicine which is prohibited to take at the same time
- Pregnant, breast-feeding women
- Subject who has sever dyshepatia (Serum creatinine level ≥ 1.7mg/dl)
- Subject who has severe renal dysfunction (ALT/AST/bilirubin value ≥ 2 upper limit of the normal range at screening test)
- Any other condition which the PI Judges would make patient unsuitable for study participation
- Subject who experienced stem cell therapy
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02221258
Start Date
October 1 2014
End Date
October 1 2015
Last Update
October 6 2016
Active Locations (1)
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1
Seoul national University Boramae medical center
Seoul, Seoul, South Korea, 156-707