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

NCT03618784 | Completed Phase 1 DMC

• 1 other identifier: K0202
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

FURESTEM-RA Inj.; Rheumatoid Arthritis; Cell therapy

Outcome Measures

Primary Outcomes (1)

• Safety of FURESTEM-RA Inj. - number of adverse events

  Evaluate the number of adverse events Safety of FURESTEM-RA Inj.

  4 weeks follow-up after treatment

Secondary Outcomes (8)

• Efficacy as measured by ACR(American College of Rheumatology)20,50,70 reaction rate

  16 weeks follow-up after treatment

• Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate

  16 weeks follow-up after treatment

• Efficacy as measured by DAS(Disease activity scores)28-ESR

  16 weeks follow-up after treatment

• Efficacy as measured by KHAQ(Korean Health assessment questionnaire)

  16 weeks follow-up after treatment

• Efficacy as measured by CDAI (clinical disease activity index)

  16 weeks follow-up after treatment

Study Arms (2)

FURESTEM-RA Inj.

EXPERIMENTAL

Biological: FURESTEM-RA Inj

Placebo Comparator: Placebo

PLACEBO COMPARATOR

Other: sterile saline

Interventions

FURESTEM-RA Inj 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

FURESTEM-RA Inj.

sterile saline 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.

Placebo Comparator: Placebo

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• of either gender, 19-80years old
• Subjects must be diagnosed according to the 2010 ACR/EULAR criteria for at least 12 weeks duration.
• Subjects must be diagnosed with ACR functional class I. II, III
• ≥ 6 tender joints, swollen joints (68 joint count) at Screening
• Subject who has moderate to severe disease activity (DAS28-ESR\>3.2) on screening visit
• 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.
• people that have no effect with permitted dose taking for more than 3 months
• people with a history of side effects of relevant treatment
• 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
• 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
• In case of taking NASAIDs, Tramadol patients with stable amount of medication at least 2 weeks before screening visit.
• During screening visit , patients with an ESR result of 28mm/hr; patients with a 1.0mg/dL or greater in a CRP testing
• Subject who understands and voluntarily sign an informed consent form

You may not qualify if:

• Subjects who is diagnosed ACR function class IV Rheumatoid Arthritis
• 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
• 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.)
• Prior use of bDMARDs, within the following windows prior to baseline
• weeks for Rituximab
• weeks for Abatacept, Golimumab, Certolizumab pegol, Tocilizumab
• weeks for Infliximab
• weeks for Etanercept
• weeks for Tofacitinib, Baricitinib
• Subject who has history of hypersensitivity, heavy metal poisoning, etc. to drugs which is composed of similar components.
• 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
• 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.
• Use of prohibited medication or inability to avoid the use of prohibited medication during the study
• Pregnant, breast-feeding women

Sponsors & Collaborators

• Kang Stem Biotech Co., Ltd.: lead

Study Sites (7)

Chonnam National University Hospital

Gwangju, South Korea

Location

Gangdong Kyung Hee University Hospital

Seoul, South Korea

Location

Konkuk University Medical Center

Seoul, South Korea

Location

Kyung Hee University Hospital

Seoul, South Korea

Location

Seoul Hospital attached to Soonchunhyang University

Seoul, South Korea

Location

Seoul national University Boramae

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 7, 2018
• Study Start: July 11, 2018
• Primary Completion: October 5, 2021
• Study Completion: May 13, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Locations

KR (7)