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NCT03509025 Clinical Trial

Follow-up Study for Participants Jointstem Clinical Trial

Knee Osteoarthritis Clinical Trial

Official title:
Open, Multicenter Follow-up Trial About Active Group of Phase IIb Clinical Trial of JOINTSTEM in Patients With Degenerative Arthritis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03509025
Other study ID # JM2b-FU
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 8, 2017
Est. completion date December 9, 2020

Study information
Verified date September 2022
Source R-Bio
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date December 9, 2020
Est. primary completion date December 9, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Korea, Republic of GangNam Severance Hospital Seoul
Korea, Republic of KyungHee University Gangdong Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
R-Bio

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events Incidence of adverse events from baseline to 60 months 60 months
Secondary WOMAC score Change from baseline on WOMAC (Western Ontario and McMaster Universities Arthritis Index) score Baseline and 12 months
Secondary WOMAC 3 subscale score Change from baseline on WOMAC 3 subscale (Pain, stiffness, and physical function) score Baseline and 12 months
Secondary X-ray X-ray perform to measure with Kellgren-Lawrence grade Baseline and 12 months
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