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

NCT03990805 | Completed Phase 3 DMC

• 1 other identifier: BSR-CTph3-JS1
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 13

Brief 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

Keywords

Stem Cell; Adipose tissue derived mesenchymal stem cell; osteoarthritis; degenerative arthritis; biostar; Rbio

Outcome Measures

Primary Outcomes (2)

• Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline

  Pain, stiffness, and physical function of the knee will be measured by the WOMAC score * Score range is 1. 0-20 for Pain 2. 0-8 for Stiffness 3. 0-68 for Pysical Function * Higher scores on the WOMAC indicate wors pain, stiffness, and functional limitations

  12 weeks, 24 weeks

• Change of Visual Analog Scale (VAS) scores from baseline

  Pain of knee will be measured by the 100mm VAS -Score range is from 0-4mm(no pain) to 75-100mm(severe pain)

  12 weeks, 24 weeks

Secondary Outcomes (11)

• WOMAC 3 subscale score

  12 weeks, 24 weeks

• VAS score

  12 weeks, 24 weeks

• KOOS

  12 weeks, 24 weeks

• SF-36

  12 weeks, 24 weeks

• IKDC

  12weeks, 24 weeks

Study Arms (2)

JOINTSTEM

EXPERIMENTAL

Autologous Adipose Tissue derived MSCs

Biological: JOINTSTEM

saline

PLACEBO COMPARATOR

saline

Drug: saline

Interventions

JOINTSTEM BIOLOGICAL

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

Also known as: Autologous Adipose Tissue derived MSCs

JOINTSTEM

saline DRUG

saline, 1 time injection

saline

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20 and older, male and female
• Patients must consent in writing to participate in the study by signing and dating an informed consent document
• Diagnosis of degenerative arthritis of class 1-3 by ACR(American College of Rheumatology Criteria) Global functional criteria
• Diagnosis of Kellgren and Lawrence grade 3 by radiographic criteria
• Patients suitable for one of three conditions of 'diagnostic criteria for osteoarthritis of knee' based on ACR guideline
• clinical and inspectional opinion
• clinical and radiographic opinion
• clinical opinion
• Patients who has joint pain ≥ 50mm on 100mm VAS (Visual Analog Scale) at Screening
• Patient who has WOMAC score ≥ 1000 at Screening
• No improvement with persisting knee pain at least for 12 weeks (3 months) by nonoperational therapy before Screening

You may not qualify if:

• Patients who have pregnancy plans within this trial period or childbearing age patients who do not agree to maintain contraception status through appropriate contraception methods
• Appropriate contraception method: Use of condom, contraceptive sponges, foam, diaphragm, intrauterine device etc.
• Periodic abstinence(e.g. methods of predicting ovulation) and moderation are not considered as appropriate contraception method.
• Not allowed to use hormonal contraceptives
• Childbearing age female patients, exclude menopausal female (amenorrhea for more than 24 months after the last menstruation) or female who has no possibility of pregnency by surgical sterilization operation, can participate in this study only determined negative in pregnancy test
• Pregnant women or lactating mothers
• Patients with Body Mass Index (BMI) \> 35
• Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), syphilis at screening indicative of current of pass infection
• Patients with other disease including
• Septic arthritis, Rheumatoid or Inflammatory joint disease, Gout, Reccurent pseudogout, Paget disease, Articular fractures, Ochronosis, Acromegaly, Hemochromatosis, Wilson's disease,Osteochondromatosis, Hereditary disorder, Genetic disorder of collagen
• Patients who are diagnosed with malignant tumor in the past or present
• Patients who have clinically significant diseases including
• Cardiac disorder (Myocardial infarction, Coronary artery bypass graft, Arrhythmia and other severe Cardiac disorder etc.)
• Resistant hypertension (systolic blood pressure \> 160mmHg or diastolic pressure \> 100mmHg at Screening)
• Kidney disease (Chronic renal failure, Glomerulonephritis etc.)

Sponsors & Collaborators

• R-Bio: lead

Study Sites (13)

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

Location

Yeungnam University Hospital

Daegu, 42415, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 42601, South Korea

Location

Chonbuk National University Hospital

Jeonju, 54907, South Korea

Location

Gyeongsang National University Hospital

Jinju, 52727, South Korea

Location

Kyunghee University Medical Center

Seoul, 02447, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Yonsei University Health System

Seoul, 03722, South Korea

Location

KyungHee University Gangdong Hospital

Seoul, 05278, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Chunang University Hospital

Seoul, 06973, South Korea

Location

Related Publications (1)

• Kim KI, Lee MC, Lee JH, Moon YW, Lee WS, Lee HJ, Hwang SC, In Y, Shon OJ, Bae KC, Song SJ, Park KK, Kim JH. Clinical Efficacy and Safety of the Intra-articular Injection of Autologous Adipose-Derived Mesenchymal Stem Cells for Knee Osteoarthritis: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial. Am J Sports Med. 2023 Jul;51(9):2243-2253. doi: 10.1177/03635465231179223. Epub 2023 Jun 21.

  PMID: 37345256 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• KANGIL KIM, M.D., Ph.D.

  KyungHee University Gangdong Hospital

  PRINCIPAL INVESTIGATOR

• WOOSUK LEE, M.D., Ph.D.

  Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

• SUNCHUL HWANG, M.D., Ph.D.

  Gyeongsang National University Hospital

  PRINCIPAL INVESTIGATOR

• SANGJUN SONG, M.D., Ph.D.

  Kyunghee University Medical Center

  PRINCIPAL INVESTIGATOR

• KICHEOR BAE, M.D., Ph.D.

  Keimyung University Dongsan Medical Center

  PRINCIPAL INVESTIGATOR

• YOUNGWAN MOON, M.D., Ph.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• JUHONG LEE, M.D., Ph.D.

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

• HANJUN LEE, M.D., Ph.D.

  Chunang University Hospital

  PRINCIPAL INVESTIGATOR

• EUISUNG CHOI, M.D., Ph.D.

  Chungbuk National University Hospital

  PRINCIPAL INVESTIGATOR

• YONG IN, M.D., Ph.D.

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

• KWANKYU PARK, M.D., Ph.D.

  Yonsei University

  PRINCIPAL INVESTIGATOR

• OOGJIN SHON, M.D., Ph.D.

  Yeungnam University Hospital

  PRINCIPAL INVESTIGATOR

• MYUNGCHUL LEE, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 19, 2019
• Study Start: June 11, 2019
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

KR (13)