NCT04427930

Brief 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P25-P50 for phase_3 knee-osteoarthritis

Timeline
20mo left

Started Apr 2020

Longer than P75 for phase_3 knee-osteoarthritis

Geographic Reach
1 country

4 active sites

Status
active not recruiting

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 Progress79%
Apr 2020Dec 2027

Study Start

First participant enrolled

April 13, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 20, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

6.7 years

First QC Date

May 20, 2020

Last Update Submit

July 7, 2023

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    Incidence of adverse events from baseline to 5 Years

    5 Years

Secondary Outcomes (8)

  • Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline

    5 Years

  • WOMAC 3 subscale score

    5 Years

  • SF-36

    5 Years

  • Measuring of Kellgren-Lawrence grade

    1, 2, 3, 4, 5 Years

  • Measuring of Femoro-tibial anatomical angle(FTA)

    1, 2, 3, 4, 5 Years

  • +3 more secondary outcomes

Study Arms (1)

JOINTSTEM

EXPERIMENTAL

Long Term Follow-up after Jointstem Transplantation

Biological: JOINTSTEM

Interventions

JOINTSTEMBIOLOGICAL

Autologous Adipose Tissue derived MSCs

JOINTSTEM

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants of Jointstem Phase 3 Clinical Trial
  • Participates who signed informed consent document of this study

You may not qualify if:

  • No applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Keimyung University Dongsan Medical Center

Daegu, 42601, South Korea

Location

KyungHee University Gangdong Hospital

Seoul, 05278, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, 06591, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • KANGIL KIM

    KyungHee University Gangdong Hospital

    PRINCIPAL INVESTIGATOR

  • WOOSUK LEE

    Gangnam Severance Hospital

    PRINCIPAL INVESTIGATOR

  • KICHEOR BAE

    Keimyung University Dongsan Medical Center

    PRINCIPAL INVESTIGATOR

  • YONG IN

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2020

First Posted

June 11, 2020

Study Start

April 13, 2020

Primary Completion (Estimated)

December 23, 2026

Study Completion (Estimated)

December 30, 2027

Last Updated

July 10, 2023

Record last verified: 2023-07

Locations

KR(4)