NCT03509025

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2 knee-osteoarthritis

Timeline
Completed

Started Feb 2017

Longer than P75 for phase_2 knee-osteoarthritis

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2017

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2020

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

3.8 years

First QC Date

March 13, 2017

Last Update Submit

September 26, 2022

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    Incidence of adverse events from baseline to 60 months

    60 months

Secondary Outcomes (3)

  • WOMAC score

    Baseline and 12 months

  • WOMAC 3 subscale score

    Baseline and 12 months

  • X-ray

    Baseline and 12 months

Study Arms (1)

Long Term Follow-up after Jointstem Transplantation

EXPERIMENTAL
Drug: Jointstem

Interventions

JointstemDRUG

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.

Also known as: autologous adipose-derived mesenchymal stem cells
Long Term Follow-up after Jointstem Transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Preparing for Pregnancy or Pregnant women or lactating mothers.
  • Patients who the principal investigator considers inappropriate for the clinical tria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

KyungHee University Gangdong Hospital

Seoul, 05278, South Korea

Location

GangNam Severance Hospital

Seoul, 06273, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • KangIl Kim, M.D., Ph.D.

    KyungHee University Gangdong Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2017

First Posted

April 26, 2018

Study Start

February 8, 2017

Primary Completion

December 9, 2020

Study Completion

December 9, 2020

Last Updated

September 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)