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Knee OsteoarthritisPhase 3NCT04427930

Follow-up Study for Participants of Jointstem Phase 3 Clinical Trial

A Phase 3 study testing JOINTSTEM in people with Knee Osteoarthritis, run by R-Bio at 4 sites in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this follow-up 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 years and older
Conditions the study is for
Knee Osteoarthritis
What is being tested?
JOINTSTEM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
4 sitesSouth Korea
Study dates
13 Apr 2020to 30 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants of Jointstem Phase 3 Clinical Trial
  • Participates who signed informed consent document of this study

Who cannot join

  • No applicable

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

  • Keimyung University Dongsan Medical Center

    Daegu, 42601

  • KyungHee University Gangdong Hospital

    Seoul, 05278

  • Gangnam Severance Hospital

    Seoul, 06273

  • The Catholic University of Korea, Seoul ST. Mary's Hospital

    Seoul, 06591

Other trials in South Korea

About this study

Official title: Long-Term Safety and Efficacy Extension Study Of Autologous Adipose-Derived Mesenchymal Stem Cells 『JOINTSTEM』 in Patients With Knee Osteoarthiritis: A Phase III Extension Study

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

Being tested
JOINTSTEM
Medical subject headings
Osteoarthritis, Knee

What participants receive

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

  • JOINTSTEMBiological

    Autologous Adipose Tissue derived MSCs

Study groups in NCT04427930
Study groupRoleWhat they receive
JOINTSTEMExperimentalLong Term Follow-up after Jointstem Transplantation
Receives: Biological: JOINTSTEM

What is being measured

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

  1. Adverse Events

    Incidence of adverse events from baseline to 5 Years

    Measured: 5 Years

Secondary outcomes (8)

  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

    Measured: 5 Years

  2. WOMAC 3 subscale score

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

    Measured: 5 Years

  3. SF-36

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

    Measured: 5 Years

  4. Measuring of Kellgren-Lawrence grade

    Measuring of Kellgren-Lawrence grade through X-ray

    Measured: 1, 2, 3, 4, 5 Years

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

    Measuring of FTA through X-ray

    Measured: 1, 2, 3, 4, 5 Years

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

    Measureing of HKA through X-ray

    Measured: 1, 2, 3, 4, 5 Years

  7. Measuring of Joint Space Width

    measuring Joint Space Width through X-ray

    Measured: 1, 2, 3, 4, 5 Years

  8. MRI scan

    The cartilage defect area is measured using MRI

    Measured: 1, 2, 3, 4, 5 Years

Timeline

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

  1. First posted11 Jun 2020
  2. Study start13 Apr 2020
  3. Primary completion23 Dec 2026 (estimated)
  4. Study completion30 Dec 2027 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04427930
Sponsor's protocol ID
BSR-CTph3-JS1_FU
Status last verified
Jul 2023
First submitted
20 May 2020
Last updated
10 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Park JB, Jang GY, Cho KY, Lee H, Kim KI. Factors affecting outcomes of intra-articular injection of autologous, culture-expanded, adipose-derived mesenchymal stem cells in knee osteoarthritis. Stem Cells Transl Med. 2026 May 18;15(6):szag027. doi: 10.1093/stcltm/szag027.

    PubMed 42184973

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JOINTSTEM in people with Knee Osteoarthritis, run by R-Bio at 4 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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

Adverse Events (time frame: 5 Years). 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 NCT04427930, 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 10 Jul 2023.

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