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Trial record 25 of 162 for:    stem cell arthritis AND Arthritis

Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03618784
Recruitment Status : Active, not recruiting
First Posted : August 7, 2018
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Kang Stem Biotech Co., Ltd.

Brief Summary:
Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid arthritis

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: FURESTEM-RA Inj Other: sterile saline Phase 1 Phase 2

Detailed Description:
Phase 1: Single center, open Phase 2a : Multi-center, randomized, double-blind, parallel, placebo Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. for Moderate to Severe Rheumatoid arthritis

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase I/2a Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. for Moderate to Severe Rheumatoid Arthritis
Actual Study Start Date : July 11, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FURESTEM-RA Inj. Biological: FURESTEM-RA Inj

The allogeneic umbilical cord blood-derived mesenchymal stem cells of each dose level as below were mixed into an IV bag containing 100 ml of sterile saline solution and the IV bag was gently massaged to obtain homogeneous mixture of the cell suspension.

Administer the constituted cell suspension by IV infusion to a subject. The infusion should be completed in 60 minutes using infusion pump.

  • Dose level 1: 5.0 x 10^7 cells
  • Dose level 2: 1.0 x 10^8 cells

Placebo Comparator: Placebo Comparator: Placebo Other: sterile saline

Placebo were mixed into an IV bag containing 100 ml of sterile saline solution and the IV bag was gently massaged to obtain homogeneous mixture of the cell suspension.

Administer the constituted cell suspension by IV infusion to a subject. The infusion should be completed in 60 minutes using infusion pump.





Primary Outcome Measures :
  1. Safety of FURESTEM-RA Inj. - number of adverse events [ Time Frame: 4 weeks follow-up after treatment ]
    Evaluate the number of adverse events Safety of FURESTEM-RA Inj.


Secondary Outcome Measures :
  1. Efficacy as measured by ACR(American College of Rheumatology)20,50,70 reaction rate [ Time Frame: 16 weeks follow-up after treatment ]
  2. Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate [ Time Frame: 16 weeks follow-up after treatment ]
  3. Efficacy as measured by DAS(Disease activity scores)28-ESR [ Time Frame: 16 weeks follow-up after treatment ]
    DAS range is from ≥ 3.2 (inactive) , >3.2 but ≤ 5.1(moderate), >5.1(very active)

  4. Efficacy as measured by KHAQ(Korean Health assessment questionnaire) [ Time Frame: 16 weeks follow-up after treatment ]
    KHAQ range is from 0 (clear) to 60 (severe)

  5. Efficacy as measured by CDAI (clinical disease activity index) [ Time Frame: 16 weeks follow-up after treatment ]
    CDAI range is from 0 (clear) to 76 (severe)

  6. Efficacy as measured by 100mm Pain VAS(Visual analogue scale) [ Time Frame: 16 weeks follow-up after treatment ]
    100mm Pain VAS range is from 0 (clear) to 100 (severe)

  7. Total number of use and consumed amount of rescue medicine [ Time Frame: 16 weeks follow-up after treatment ]
  8. Change in Cytokine(TNF-a, Interleukin (IL)-1b, IL-4,IL-6,IL-8,IL-10,IL-13,IL-17A,IL-21,IL-22) [ Time Frame: 16 weeks follow-up after treatment ]


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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
Criteria

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. ≥ 6 tender joints, swollen joints (68 joint count) at Screening
  4. Subject who has moderate to severe disease activity (DAS28-ESR>3.2) on screening visit
  5. History of treatment for one of biologic DMARDs AND people diagnosed with either (a) or (b) by a trained person, or people that have potential side effects thus not qualified from using biologic DMARDs.

    1. people that have no effect with permitted dose taking for more than 6 months
    2. people with a history of side effects of relevant treatment
  6. Subjects must be taking cDMARDs including methotrexate, sulfasalazine, hydroxychloroquine, leflunomide of stable dose More than 12 weeks before baseline visit and be willing to remain on stable dose throughout the study
  7. 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
  8. In case of taking NASAIDs, patients with stable amount of medication at least 2 weeks before screening visit.
  9. ) During screening visit , patients with an ESR result of 28mm/hr; patients with a 1.0mg/dL or greater in a CRP testing
  10. 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. Prior use of bDMARDs, within the following windows prior to baseline

    • 24 weeks for Rituximab
    • 12 weeks for Infliximab, Abatacept, Tocilizumab, Golimumab
    • 8 weeks for Etanercept, Adalimumab, Certolizumab pegol
  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. Use of prohibited medication or inability to avoid the use of prohibited medication during the study
  9. Pregnant, breast-feeding women
  10. A female or male in their childbearing ages that is not willing to take proper contraceptive methods during a study
  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

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): NCT03618784


Locations
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Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
Gangdong Kyung Hee University Hospital
Seoul, Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of
Kyung Hee University Hospital
Seoul, Korea, Republic of
Seoul Hospital attached to Soonchunhyang University
Seoul, Korea, Republic of
Seoul national University Boramae
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Kang Stem Biotech Co., Ltd.

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Responsible Party: Kang Stem Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT03618784     History of Changes
Other Study ID Numbers: K0202
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kang Stem Biotech Co., Ltd.:
FURESTEM-RA Inj.
Rheumatoid Arthritis
Cell therapy
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases