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

NCT ID: NCT03618784

Last Updated: 2022-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-11
• Study Completion Date: 2022-05-13

Brief Summary

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

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

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FURESTEM-RA Inj.

Group Type: EXPERIMENTAL

FURESTEM-RA Inj

Intervention Type: BIOLOGICAL

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 /body 3 repeated intravenous injection at 4 week intervals
• Dose level 2: 1.0 x 10^8 cells /body 3 repeated intravenous injection at 4 week intervals

Placebo Comparator: Placebo

Group Type: PLACEBO_COMPARATOR

sterile saline

Intervention Type: OTHER

sterile saline 3 repeated intravenous injection at 4 week intervals

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.

Interventions

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 /body 3 repeated intravenous injection at 4 week intervals
• Dose level 2: 1.0 x 10^8 cells /body 3 repeated intravenous injection at 4 week intervals

Intervention Type: BIOLOGICAL

sterile saline

sterile saline 3 repeated intravenous injection at 4 week intervals

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. of either gender, 19-80years old

2. Subjects must be diagnosed according to the 2010 ACR/EULAR criteria for at least 12 weeks duration.

3. Subjects must be diagnosed with ACR functional class I. II, III

4. ≥ 6 tender joints, swollen joints (68 joint count) at Screening

5. Subject who has moderate to severe disease activity (DAS28-ESR>3.2) on screening visit

6. History of treatment for one of conventional DMARDs or biologic DMARDs or JAK inhibitors 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 3 months

2. people with a history of side effects of relevant treatment

7. Subjects must be taking cDMARDs(including methotrexate, sulfasalazine, hydroxychloroquine, leflunomide) or tacrolimus of stable dose More than 12 weeks before baseline visit and be willing to remain on stable dose throughout the study

8. 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

9. In case of taking NASAIDs, Tramadol patients with stable amount of medication at least 2 weeks before screening visit.

10. During screening visit , patients with an ESR result of 28mm/hr; patients with a 1.0mg/dL or greater in a CRP testing

11. Subject who understands and voluntarily sign an informed consent form

Exclusion Criteria

1. Subjects who is diagnosed ACR function class IV Rheumatoid Arthritis

2. Patients who are judged by the PI(or Sub-I) to be unable to participate in clinical trials due to uncontrolled or unstable cardiovascular disease or severe blood disease

3. Subjects who has AIDS, other rheumatic disease(Crohn's disease, systemic lupus erythematosus, lyme disease, psoriatic arthritis, spondylarthropathy, infectious or reactive arthritis, reiter's syndrome, etc.)

4. Prior use of bDMARDs, within the following windows prior to baseline

• 24 weeks for Rituximab
• 10 weeks for Abatacept, Golimumab, Certolizumab pegol, Tocilizumab
• 7 weeks for Infliximab
• 4 weeks for Etanercept
• 3 weeks for Tofacitinib, Baricitinib

5. Subject who has history of hypersensitivity, heavy metal poisoning, etc. to drugs which is composed of similar components.

6. Subject who has treated intravenous, intramuscular steroid injection within 2 weeks before screening visit or intra-articular steroid injection within 4 weeks before screening visit

7. Subject who has administered ACTH(adrenocorticotropic hormone) agents within 4 weeks before screening visit

8. Subject who has undergone administration of any investigational drug within 30 days before screening visit.

9. Use of prohibited medication or inability to avoid the use of prohibited medication during the study

10. Pregnant, breast-feeding women

11. A female or male in their childbearing ages that is not willing to take proper contraceptive methods during a study

12. Subject who has sever dyshepatia (Serum creatinine level ≥ 1.7mg/dl)

13. Subject who has severe renal dysfunction (ALT/AST/bilirubin value ≥ 2 upper limit of the normal range at screening test)

14. Any other condition which the PI Judges would make patient unsuitable for study participation

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kang Stem Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chonnam National University Hospital

Gwangju, , South Korea

Gangdong Kyung Hee University Hospital

Seoul, , South Korea

Konkuk University Medical Center

Seoul, , South Korea

Kyung Hee University Hospital

Seoul, , South Korea

Seoul Hospital attached to Soonchunhyang University

Seoul, , South Korea

Seoul national University Boramae

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

K0202

Identifier Type: -

Identifier Source: org_study_id