Clinical Trials Logo
  1. Home
  2. Knee Osteoarthritis
  3. NCT04427930
  4. Details
NCT04427930 Clinical Trial

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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04427930
Other study ID # BSR-CTph3-JS1_FU
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date April 13, 2020
Est. completion date December 30, 2027

Study information
Verified date July 2023
Source R-Bio
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 129
Est. completion date December 30, 2027
Est. primary completion date December 23, 2026
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Participants of Jointstem Phase 3 Clinical Trial - Participates who signed informed consent document of this study Exclusion Criteria: - No applicable

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• JOINTSTEM
Autologous Adipose Tissue derived MSCs

Locations
Country Name City State
Korea, Republic of Keimyung University Dongsan Medical Center Daegu
Korea, Republic of Gangnam Severance Hospital Seoul
Korea, Republic of KyungHee University Gangdong Hospital Seoul
Korea, Republic of The Catholic University of Korea, Seoul ST. Mary's 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 5 Years 5 Years
Secondary Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline Pain, stiffness, and physical function of the knee will be measured by the WOMAC score 5 Years
Secondary WOMAC 3 subscale score Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC) 5 Years
Secondary SF-36 The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health. 5 Years
Secondary Measuring of Kellgren-Lawrence grade Measuring of Kellgren-Lawrence grade through X-ray 1, 2, 3, 4, 5 Years
Secondary Measuring of Femoro-tibial anatomical angle(FTA) Measuring of FTA through X-ray 1, 2, 3, 4, 5 Years
Secondary Measuring of Hip-Knee-Ankle angle(HKA) Measureing of HKA through X-ray 1, 2, 3, 4, 5 Years
Secondary Measuring of Joint Space Width measuring Joint Space Width through X-ray 1, 2, 3, 4, 5 Years
Secondary MRI scan The cartilage defect area is measured using MRI 1, 2, 3, 4, 5 Years
See also
  Status Clinical Trial Phase
Recruiting NCT04651673 - Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
Completed NCT05677399 - Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise. N/A
Active, not recruiting NCT04043819 - Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis Phase 1
Recruiting NCT06000410 - A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee Phase 3
Completed NCT05014542 - Needling Techniques for Knee Osteoarthritis N/A
Recruiting NCT05892133 - Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty N/A
Recruiting NCT05528965 - Parallel Versus Perpendicular Technique for Genicular Radiofrequency N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Active, not recruiting NCT02003976 - A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone N/A
Active, not recruiting NCT04017533 - Stability of Uncemented Medially Stabilized TKA N/A
Completed NCT04779164 - The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis N/A
Recruiting NCT04006314 - Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis N/A
Recruiting NCT05423587 - Genicular Artery Embolisation for Knee Osteoarthritis II N/A
Enrolling by invitation NCT04145401 - Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
Active, not recruiting NCT03781843 - Effects of Genicular Nerve Block in Knee Osteoarthritis N/A
Completed NCT05974501 - Pre vs Post Block in Total Knee Arthroplasty (TKA) Phase 4
Completed NCT05324163 - Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis Phase 3
Completed NCT05529914 - Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis N/A
Recruiting NCT05693493 - Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA? N/A
Not yet recruiting NCT05510648 - Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis N/A