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Degenerative ArthritisPhase 3NCT03990805

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

A Phase 3 study testing JOINTSTEM and saline in people with Degenerative Arthritis and Knee Osteoarthritis, run by R-Bio at 13 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 100 years
Conditions the study is for
Degenerative Arthritis, Knee Osteoarthritis
What is being tested?
JOINTSTEM and saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
260 participants
Where
13 sitesSouth Korea
Study dates
11 Jun 2019to 15 Dec 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 37Show fewer
  • 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.)
  • Liver disease (Hepatocirrhosis, Fatty liver, acute or chronic liver disease etc.)
  • Endocrinopathy (Thyroiditis, Diabetes insipidus, Cushing disease etc.)
  • Patients who have significant lab abnormalities
  • Patients who have severe pain in other areas that can affect the judgement of knee joint symptom
  • Patients who underwent any arthroscopic surgery on the injection site within 6 months of the screening visit date, or scheduled to perform any surgery during the clinical trial period
  • Patients who received any drug by intra-articular injection(hyaluronic acid or steroid etc.) for treatment within 6 months prior to Screening
  • Patients who experienced as stem cell therapy or blood product injection(PRP, Prolo injection etc.)
  • Patients who received treatment within 14 days prior to Screening including(But, patients who had wash-out-period can participate in this study)
  • Take medicines including composition of Glucosamine, Chondretin sulphate and Diacerhein etc.
  • Take phytotherapeutic agent or Chinese medicine for osteoarthritis
  • Take antiinflammatory analgesic drug, NSAIDs (prescription/nonprescription pharmaceuticals) etc. (Patients who have 3 days of wash-out-period after they took acetaminophen can participate in the study)
  • Take oral steroids
  • Physical therapy or Chinese medical treatment(cupping, acupuncture, moxibustion etc.)
  • Patients with penicillin hypersensitivity reactions
  • Patients with skin diseases or infections in the area of the injection site
  • Patients who have abnormal flail over grade 2 flail knee test of anterior to posterior and varus/valgus lesion at physical examination
  • Patients who have difficulty in taking MRI because of metal materials (cardiac pacemaker or clip of cerebral artery etc.) in their body or claustrophobia -but, patients with metal materials that are not affected by magnetic field can participate in this study
  • Patients who have difficulty in liposuction or local anesthesia
  • Patients who have alcohol, drug abuse history
  • Patients who have severe neurologic and psychiatric disorders that affect clinical trials
  • Patients who had participated in other clinical trials within 12 weeks prior to this study
  • Patients who the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

South Korea13 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Yeungnam University Hospital

    Daegu, 42415

  • Keimyung University Dongsan Medical Center

    Daegu, 42601

  • Chonbuk National University Hospital

    Jeonju, 54907

  • Gyeongsang National University Hospital

    Jinju, 52727

  • Kyunghee University Medical Center

    Seoul, 02447

  • Seoul National University Hospital

    Seoul, 03080

  • Yonsei University Health System

    Seoul, 03722

  • KyungHee University Gangdong Hospital

    Seoul, 05278

  • Gangnam Severance Hospital

    Seoul, 06273

  • Samsung Medical Center

    Seoul, 06351

  • Seoul St. Mary's Hospital

    Seoul, 06591

  • Chunang University Hospital

    Seoul, 06973

Other trials in South Korea

About this study

Official title: Multi-center, Randomized, Double-Blind, Placebo Controlled Phase 3 Clinical Trial to Evaluate Efficacy and Safty of Mesenchymal Stem Cells JointStem in Patients With Knee Osteoarthritis

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.

Read the detailed description

JOINTSTEM is injectables for an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues and is cultured without additional genetic modification, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.

It primarily aims to improve joint function. The intra-articular injection of JOINTSTEM is expected to stimulate the regeneration of cartilage, and to innovatively improve joint function with cartilage regeneration.

The subjects of this therapy were patients with K\&L grade 3 aged 20 or older.

This study is a double-blind, randomized, placebo controlled study with two arms to evaluate JOINTSTEM as a treatment for subjects with osteoarthritis. Following a 2-week screening period, approximately 260 patients will be randomly assigned into one of the following two arms in a 1:1 ratio (1 JointStem : 1 placebo control). After each patient completes 6-month visit (Visit 5) and the data management team confirms all data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.

Being tested
JOINTSTEM, saline
Keywords
Stem Cell, Adipose tissue derived mesenchymal stem cell, osteoarthritis, degenerative arthritis, biostar, Rbio
Medical subject headings
Osteoarthritis, Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JOINTSTEMBiological

    Also called Autologous Adipose Tissue derived MSCs

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

  • salineDrug

    saline, 1 time injection

Study groups in NCT03990805
Study groupRoleWhat they receive
JOINTSTEMExperimentalAutologous Adipose Tissue derived MSCs
Receives: Biological: JOINTSTEM
salinePlacebo comparatorsaline
Receives: Drug: saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 weeks, 24 weeks

  2. 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)

    Measured: 12 weeks, 24 weeks

Secondary outcomes (11)

  1. WOMAC 3 subscale score

    Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)

    Measured: 12 weeks, 24 weeks

  2. VAS score

    Pain of knee will be measured by the 100mm Visual Analog Scale (VAS)

    Measured: 12 weeks, 24 weeks

  3. KOOS

    Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS)

    -Score range is from 0(extreme symptoms) to 100(no symptoms)

    Measured: 12 weeks, 24 weeks

  4. SF-36

    The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.

    Measured: 12 weeks, 24 weeks

  5. IKDC

    Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)

    Measured: 12weeks, 24 weeks

  6. Measuring of Kellgren-Lawrence grade

    Measuring of Kellgren-Lawrence grade through X-ray

    Measured: 12 weeks, 24 weeks

  7. Measuring of Femoro-tibial anatomical angle(FTA)

    Measuring of FTA through X-ray

    Measured: 12 weeks, 24 weeks

  8. Measuring of Hip-Knee-Ankle angle(HKA)

    Measureing of HKA through X-ray

    Measured: 12 weeks, 24 weeks

  9. Measuring of Joint Space Width

    measuring Joint Space Width through X-ray

    Measured: 12 weeks, 24 weeks

  10. MRI scan

    MRI perform to measure Modified WORMS (Whole-Organ Magnetic Resonance Imaging Score)

    Measured: 12 weeks, 24 weeks

  11. Use of rescue medication

    Frequency and total amount of rescue medication administration will be measured.

    Measured: 12 weeks, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2019
  2. Study start11 Jun 2019
  3. Primary completion15 Dec 2020
  4. Study completion15 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03990805
Sponsor's protocol ID
BSR-CTph3-JS1
Status last verified
Sep 2022
First submitted
13 Jun 2019
Last updated
28 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37345256

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JOINTSTEM and saline in people with Degenerative Arthritis and Knee Osteoarthritis, run by R-Bio at 13 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline (time frame: 12 weeks, 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03990805, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.

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