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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

July 11, 2018

Primary Completion Date

October 5, 2021

Study Completion Date

May 13, 2022

Conditions
Rheumatoid Arthritis
Interventions
BIOLOGICAL

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"

OTHER

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."

Trial Locations (7)

Unknown

Chonnam National University Hospital, Gwangju

Gangdong Kyung Hee University Hospital, Seoul

Konkuk University Medical Center, Seoul

Kyung Hee University Hospital, Seoul

Seoul Hospital attached to Soonchunhyang University, Seoul

Seoul national University Boramae, Seoul

Seoul National University Hospital, Seoul

All Listed Sponsors
lead

Kang Stem Biotech Co., Ltd.

INDUSTRY

NCT03618784 - Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter