Follow-up Study for Participants Jointstem Clinical Trial

September 26, 2022 updated by: R-Bio

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06273
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 05278
        • KyungHee University Gangdong Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 60 months
Incidence of adverse events from baseline to 60 months
60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC score
Time Frame: Baseline and 12 months
Change from baseline on WOMAC (Western Ontario and McMaster Universities Arthritis Index) score
Baseline and 12 months
WOMAC 3 subscale score
Time Frame: Baseline and 12 months
Change from baseline on WOMAC 3 subscale (Pain, stiffness, and physical function) score
Baseline and 12 months
X-ray
Time Frame: Baseline and 12 months
X-ray perform to measure with Kellgren-Lawrence grade
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R-Bio

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2017

Primary Completion (Actual)

December 9, 2020

Study Completion (Actual)

December 9, 2020

Study Registration Dates

First Submitted

March 13, 2017

First Submitted That Met QC Criteria

April 25, 2018

First Posted (Actual)

April 26, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JM2b-FU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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