Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid arthritis
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
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
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.
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
Safety of FURESTEM-RA Inj. - number of adverse events
Evaluate the number of adverse events Safety of FURESTEM-RA Inj.
Time frame: 4 weeks follow-up after treatment
Efficacy as measured by ACR(American College of Rheumatology)20,50,70 reaction rate
Time frame: 16 weeks follow-up after treatment
Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate
Time frame: 16 weeks follow-up after treatment
Efficacy as measured by DAS(Disease activity scores)28-ESR
DAS range is from ≥ 3.2 (inactive) , \>3.2 but ≤ 5.1(moderate), \>5.1(very active)
Time frame: 16 weeks follow-up after treatment
Efficacy as measured by KHAQ(Korean Health assessment questionnaire)
KHAQ range is from 0 (clear) to 60 (severe)
Time frame: 16 weeks follow-up after treatment
Efficacy as measured by CDAI (clinical disease activity index)
CDAI range is from 0 (clear) to 76 (severe)
Time frame: 16 weeks follow-up after treatment
Efficacy as measured by 100mm Pain VAS(Visual analogue scale)
100mm Pain VAS range is from 0 (clear) to 100 (severe)
Time frame: 16 weeks follow-up after treatment
Total number of use and consumed amount of rescue medicine
Time frame: 16 weeks follow-up after treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Seoul Hospital attached to Soonchunhyang University
Seoul, South Korea
Seoul national University Boramae
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
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