Rheumatoid Arthritis Clinical Trial
— RAOfficial title:
Phase 1 Clinical Trial to Evaluate the Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis
Verified date | March 2015 |
Source | Kang Stem Biotech Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Ministry of Food and Drug Safety |
Study type | Interventional |
The purpose of phase 1 clinical trial is to to evaluate safety in subjects with moderate to severe rheumatoid arthritis after infusion.
Status | Completed |
Enrollment | 9 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. of either gender, 19-80years old 2. 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. 3. 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 4. 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 5. Subject who has moderate to severe disease activity (DAS28-ESR>3.2) on screening visit 6. Subject who understands and voluntarily sign an informed consent form Exclusion Criteria: 1. Subjects who is diagnosed ACR function class IV Rheumatoid Arthritis 2. 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.) 3. 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 4. Subject who has history of hypersensitivity, heavy metal poisoning, etc. to drugs which is composed of similar components. 5. Subject who has treated intra-articular steroid injection within 4 weeks before screening visit 6. Subject who has administered ACTH(adrenocorticotropic hormone) agents within 4 weeks before screening visit 7. Subject who has undergone administration of any investigational drug within 30 days before screening visit. 8. Subject who has diseases or takes medicine which are prohibited prescription of NSAIDs. 9. Subject who needs to take the medicine which is prohibited to take at the same time 10. Pregnant, breast-feeding women 11. Subject who has sever dyshepatia (Serum creatinine level = 1.7mg/dl) 12. Subject who has severe renal dysfunction (ALT/AST/bilirubin value = 2 upper limit of the normal range at screening test) 13. Any other condition which the PI Judges would make patient unsuitable for study participation 14. Subject who experienced stem cell therapy |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul national University Boramae medical center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Kang Stem Biotech Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of FURESTEM-RA Inj. treatment | Evaluate the number of adverse events, including clinically significant changes in physical examination, safety lab tests, ECG, vital signs | 4 weeks follow-up after treatment | No |
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