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
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

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