Working… Menu

Follow-up Study for Participants Jointstem Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03509025
Recruitment Status : Active, not recruiting
First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Jointstem Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open, Multicenter Follow-up Trial About Active Group of Phase IIb Clinical Trial of JOINTSTEM in Patients With Degenerative Arthritis
Actual Study Start Date : February 8, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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 Name: autologous adipose-derived mesenchymal stem cells

Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 48 month ]
    Incidence and frequency of adverse events from baseline to 48 months

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Baseline, 6, 12, 18, 24 and 36 months ]
    Incidence and frequency of adverse events

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03509025

Layout table for location information
Korea, Republic of
KyungHee University Gangdong Hospital
Seoul, Korea, Republic of, 05278
GangNam Severance Hospital
Seoul, Korea, Republic of, 06273
Sponsors and Collaborators
Layout table for investigator information
Principal Investigator: KangIl Kim, M.D., Ph.D. KyungHee University Gangdong Hospital

Layout table for additonal information
Responsible Party: R-Bio Identifier: NCT03509025     History of Changes
Other Study ID Numbers: JM2b-FU
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases