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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
FURESTEM-RA Inj.
Sponsored by
Kang Stem Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Rheumatic Disease, RA, Stem cell, Cell therapy, furestem, Umbilical cord Blood, hUCB-MSC, UCB-MSC

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul national University Boramae medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FURESTEM-RA Inj.+DMARDs

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 18, 2014
Last Updated
October 5, 2016
Sponsor
Kang Stem Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02221258
Brief Title
Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis(RA)
Acronym
RA
Official Title
Phase 1 Clinical Trial to Evaluate the Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kang Stem Biotech Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Rheumatic Disease, RA, Stem cell, Cell therapy, furestem, Umbilical cord Blood, hUCB-MSC, UCB-MSC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FURESTEM-RA Inj.+DMARDs
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
FURESTEM-RA Inj.
Intervention Description
Patients will be treated FURESTEM-RA Inj.+DMARDs(Disease-Modifying antirheumatic drugs)
Primary Outcome Measure Information:
Title
Safety of FURESTEM-RA Inj. treatment
Description
Evaluate the number of adverse events, including clinically significant changes in physical examination, safety lab tests, ECG, vital signs
Time Frame
4 weeks follow-up after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kichul Shin
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul national University Boramae medical center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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