A Phase 3 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis

Summary

The purpose of this study is to investigate the efficacy and safety of autologous Adipose Tissue derived Mesenchymal stem cells (JOINTSTEM®) in patient with severe Knee Osteoarthritis.

Conditions

• Degenerative Arthritis
• Knee Osteoarthritis

Interventions

BIOLOGICAL

JOINTSTEM

JOINTSTEM Autologous Adipose Tissue derived MSCs 1x10\^8cells/(saline), 1 time injection

DRUG

saline

saline, 1 time injection

Sponsors & Collaborators

• R-Bio

  lead INDUSTRY

Principal Investigators

• KANGIL KIM, M.D., Ph.D. · KyungHee University Gangdong Hospital

• WOOSUK LEE, M.D., Ph.D. · Gangnam Severance Hospital

• SUNCHUL HWANG, M.D., Ph.D. · Gyeongsang National University Hospital

• SANGJUN SONG, M.D., Ph.D. · Kyunghee University Medical Center

• KICHEOR BAE, M.D., Ph.D. · Keimyung University Dongsan Medical Center

• YOUNGWAN MOON, M.D., Ph.D. · Samsung Medical Center

• JUHONG LEE, M.D., Ph.D. · Chonbuk National University Hospital

• HANJUN LEE, M.D., Ph.D. · Chunang University Hospital

• EUISUNG CHOI, M.D., Ph.D. · Chungbuk National University Hospital

• YONG IN, M.D., Ph.D. · Seoul St. Mary's Hospital

• KWANKYU PARK, M.D., Ph.D. · Yonsei University

• OOGJIN SHON, M.D., Ph.D. · Yeungnam University Hospital

• MYUNGCHUL LEE, M.D., Ph.D. · Seoul National University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-11

Primary Completion

2020-12-15

Completion

2020-12-15

Countries

• South Korea

Study Locations