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

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ClinicalTrials.gov Identifier: NCT04427930
Recruitment Status : Enrolling by invitation
First Posted : June 11, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
R-Bio

Brief 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: JOINTSTEM Drug: Saline Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 13, 2020
Estimated Primary Completion Date : December 23, 2026
Estimated Study Completion Date : December 30, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: JOINTSTEM
Long Term Follow-up after Jointstem Transplantation
Biological: JOINTSTEM
Autologous Adipose Tissue derived MSCs

Placebo Comparator: Saline Drug: Saline
Saline




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 54 Months ]
    Incidence of adverse events from baseline to 54 monthss


Secondary Outcome Measures :
  1. Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline [ Time Frame: 54 Months ]
    Pain, stiffness, and physical function of the knee will be measured by the WOMAC score

  2. WOMAC 3 subscale score [ Time Frame: 54 Months ]
    Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)

  3. SF-36 [ Time Frame: 54 Months ]
    The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.

  4. Measuring of Kellgren-Lawrence grade [ Time Frame: 6, 18 Months ]
    Measuring of Kellgren-Lawrence grade through X-ray

  5. Measuring of Femoro-tibial anatomical angle(FTA) [ Time Frame: 6, 18 Months ]
    Measuring of FTA through X-ray

  6. Measuring of Hip-Knee-Ankle angle(HKA) [ Time Frame: 6, 18 Months ]
    Measureing of HKA through X-ray

  7. Measuring of Joint Space Width [ Time Frame: 6, 18 Months ]
    measuring Joint Space Width through X-ray

  8. MRI scan [ Time Frame: 6, 18 Months ]
    MRI perform to measure Modified WORMS (Whole-Organ Magnetic Resonance Imaging Score)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No applicable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04427930


Locations
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Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of, 42601
KyungHee University Gangdong Hospital
Seoul, Korea, Republic of, 05278
Gangnam Severance Hospital
Seoul, Korea, Republic of, 06273
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, Korea, Republic of, 06591
Sponsors and Collaborators
R-Bio
Investigators
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Principal Investigator: KANGIL KIM KyungHee University Gangdong Hospital
Principal Investigator: WOOSUK LEE Gangnam Severance Hospital
Principal Investigator: KICHEOR BAE Keimyung University Dongsan Medical Center
Principal Investigator: YONG IN The Catholic University of Korea
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Responsible Party: R-Bio
ClinicalTrials.gov Identifier: NCT04427930    
Other Study ID Numbers: BSR-CTph3-JS1_FU
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases