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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 20, 2020
First Posted Date  ICMJE June 11, 2020
Last Update Posted Date September 25, 2020
Actual Study Start Date  ICMJE April 13, 2020
Estimated Primary Completion Date December 23, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2020)
Adverse Events [ Time Frame: 54 Months ]
Incidence of adverse events from baseline to 54 monthss
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2020)
  • 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
  • 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)
  • SF-36 [ Time Frame: 54 Months ]
    The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.
  • Measuring of Kellgren-Lawrence grade [ Time Frame: 6, 18 Months ]
    Measuring of Kellgren-Lawrence grade through X-ray
  • Measuring of Femoro-tibial anatomical angle(FTA) [ Time Frame: 6, 18 Months ]
    Measuring of FTA through X-ray
  • Measuring of Hip-Knee-Ankle angle(HKA) [ Time Frame: 6, 18 Months ]
    Measureing of HKA through X-ray
  • Measuring of Joint Space Width [ Time Frame: 6, 18 Months ]
    measuring Joint Space Width through X-ray
  • MRI scan [ Time Frame: 6, 18 Months ]
    MRI perform to measure Modified WORMS (Whole-Organ Magnetic Resonance Imaging Score)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Follow-up Study for Participants of Jointstem Phase 3 Clinical Trial
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Biological: JOINTSTEM
    Autologous Adipose Tissue derived MSCs
  • Drug: Saline
    Saline
Study Arms  ICMJE
  • Experimental: JOINTSTEM
    Long Term Follow-up after Jointstem Transplantation
    Intervention: Biological: JOINTSTEM
  • Placebo Comparator: Saline
    Intervention: Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 9, 2020)
260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2027
Estimated Primary Completion Date December 23, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • No applicable
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04427930
Other Study ID Numbers  ICMJE BSR-CTph3-JS1_FU
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party R-Bio
Study Sponsor  ICMJE R-Bio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account R-Bio
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP