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

NCT02221258 | Completed Phase 1 DMC

• 1 other identifier: KSB-RA
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Rheumatic Disease; RA; Stem cell; Cell therapy; furestem; Umbilical cord Blood; hUCB-MSC; UCB-MSC

Outcome Measures

Primary Outcomes (1)

• 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

  4 weeks follow-up after treatment

Study Arms (1)

FURESTEM-RA Inj.+DMARDs

EXPERIMENTAL

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.

Interventions

FURESTEM-RA Inj. BIOLOGICAL

Patients will be treated FURESTEM-RA Inj.+DMARDs(Disease-Modifying antirheumatic drugs)

FURESTEM-RA Inj.+DMARDs

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kang Stem Biotech Co., Ltd.: lead

Study Sites (1)

Seoul national University Boramae medical center

Seoul, Seoul, 156-707, South Korea

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Rheumatic Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Kichul Shin

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 20, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 6, 2016

Record last verified: 2015-03

Locations

KR (1)