Back to resultsFollow-up Study for Participants Jointstem Clinical Trial
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Jointstem
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
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
Sites / Locations
- KyungHee University Gangdong Hospital
- GangNam Severance Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Long Term Follow-up after Jointstem Transplantation
Arm Description
Outcomes
Primary Outcome Measures
Adverse Events
Incidence of adverse events from baseline to 60 months
Secondary Outcome Measures
WOMAC score
Change from baseline on WOMAC (Western Ontario and McMaster Universities Arthritis Index) score
WOMAC 3 subscale score
Change from baseline on WOMAC 3 subscale (Pain, stiffness, and physical function) score
X-ray
X-ray perform to measure with Kellgren-Lawrence grade
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03509025
Brief Title
Follow-up Study for Participants Jointstem Clinical Trial
Official Title
Open, Multicenter Follow-up Trial About Active Group of Phase IIb Clinical Trial of JOINTSTEM in Patients With Degenerative Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 8, 2017 (Actual)
Primary Completion Date
December 9, 2020 (Actual)
Study Completion Date
December 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
R-Bio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Long Term Follow-up after Jointstem Transplantation
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Jointstem
Other Intervention Name(s)
autologous adipose-derived mesenchymal stem cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse Events
Description
Incidence of adverse events from baseline to 60 months
Time Frame
60 months
Secondary Outcome Measure Information:
Title
WOMAC score
Description
Change from baseline on WOMAC (Western Ontario and McMaster Universities Arthritis Index) score
Time Frame
Baseline and 12 months
Title
WOMAC 3 subscale score
Description
Change from baseline on WOMAC 3 subscale (Pain, stiffness, and physical function) score
Time Frame
Baseline and 12 months
Title
X-ray
Description
X-ray perform to measure with Kellgren-Lawrence grade
Time Frame
Baseline and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KangIl Kim, M.D., Ph.D.
Organizational Affiliation
KyungHee University Gangdong Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KyungHee University Gangdong Hospital
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of
Facility Name
GangNam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Follow-up Study for Participants Jointstem Clinical Trial
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