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Follow-up Study for Participants Jointstem Clinical Trial

Sponsor
R-Bio (Industry)
Overall Status
Completed
CT.gov ID
NCT03509025
Collaborator
(none)
11
Enrollment
2
Locations
1
Arm
46
Actual Duration (Months)
5.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a long term follow-up study to investigate the safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Knee Osteoarthritis.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open, Multicenter Follow-up Trial About Active Group of Phase IIb Clinical Trial of JOINTSTEM in Patients With Degenerative Arthritis
Actual Study Start Date :
Feb 8, 2017
Actual Primary Completion Date :
Dec 9, 2020
Actual Study Completion Date :
Dec 9, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Long Term Follow-up after Jointstem Transplantation

Drug: Jointstem
JOINTSTEM is an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues and is incubated without additional genetic modification or mechanical and chemical modification through differentiation, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.
Other Names:
  • autologous adipose-derived mesenchymal stem cells

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Events [60 months]

      Incidence of adverse events from baseline to 60 months

    Secondary Outcome Measures

    1. WOMAC score [Baseline and 12 months]

      Change from baseline on WOMAC (Western Ontario and McMaster Universities Arthritis Index) score

    2. WOMAC 3 subscale score [Baseline and 12 months]

      Change from baseline on WOMAC 3 subscale (Pain, stiffness, and physical function) score

    3. X-ray [Baseline and 12 months]

      X-ray perform to measure with Kellgren-Lawrence grade

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients must consent in writing to participate in the study by signing and dating an informed consent document

    • Patients who transplanted Jointstem on phase 2b clinical trial

    Exclusion Criteria:

    • Preparing for Pregnancy or Pregnant women or lactating mothers.

    • Patients who the principal investigator considers inappropriate for the clinical tria

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 KyungHee University Gangdong Hospital Seoul Korea, Republic of 05278
    2 GangNam Severance Hospital Seoul Korea, Republic of 06273

    Sponsors and Collaborators

    • R-Bio

    Investigators

    • Principal Investigator: KangIl Kim, M.D., Ph.D., KyungHee University Gangdong Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    R-Bio
    ClinicalTrials.gov Identifier:
    NCT03509025
    Other Study ID Numbers:
    • JM2b-FU
    First Posted:
    Apr 26, 2018
    Last Update Posted:
    Jan 29, 2021
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee

    Study Results

    No Results Posted as of Jan 29, 2021