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Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis(RA) (RA)

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ClinicalTrials.gov Identifier: NCT02221258
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : October 6, 2016
Information provided by (Responsible Party):
Kang Stem Biotech Co., Ltd.

Brief Summary:
The purpose of phase 1 clinical trial is to to evaluate safety in subjects with moderate to severe rheumatoid arthritis after infusion.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: FURESTEM-RA Inj. Phase 1

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 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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Clinical Trial to Evaluate the Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis
Study Start Date : October 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: FURESTEM-RA Inj.+DMARDs
FURESTEM-RA Inj. 1. 2.5x10^7 stem cells+DMARDs after registration FURESTEM-RA Inj. 2. 5.0x10^7 stem cells+DMARDs after registration FURESTEM-RA Inj. 3. 1.0x10^8 stem cells+DMARDs after registration
Biological: FURESTEM-RA Inj.
Patients will be treated FURESTEM-RA Inj.+DMARDs(Disease-Modifying antirheumatic drugs)

Primary Outcome Measures :
  1. Safety of FURESTEM-RA Inj. treatment [ Time Frame: 4 weeks follow-up after treatment ]
    Evaluate the number of adverse events, including clinically significant changes in physical examination, safety lab tests, ECG, vital signs

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221258

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Korea, Republic of
Seoul national University Boramae medical center
Seoul, Korea, Republic of, 156-707
Sponsors and Collaborators
Kang Stem Biotech Co., Ltd.
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Principal Investigator: Kichul Shin SMG-SNU Boramae Medical Center
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Responsible Party: Kang Stem Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT02221258    
Other Study ID Numbers: KSB-RA
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: March 2015
Keywords provided by Kang Stem Biotech Co., Ltd.:
Rheumatoid Arthritis
Rheumatic Disease
Stem cell
Cell therapy
Umbilical cord Blood
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases