Follow-up Study for Participants of Jointstem Phase 3 Clinical Trial

NCT ID: NCT04427930

Last Updated: 2023-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-13

Study Completion Date

2027-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JOINTSTEM

Long Term Follow-up after Jointstem Transplantation

Group Type EXPERIMENTAL

JOINTSTEM

Intervention Type BIOLOGICAL

Autologous Adipose Tissue derived MSCs

Interventions

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JOINTSTEM

Autologous Adipose Tissue derived MSCs

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No applicable
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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R-Bio

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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KANGIL KIM

Role: PRINCIPAL_INVESTIGATOR

KyungHee University Gangdong Hospital

WOOSUK LEE

Role: PRINCIPAL_INVESTIGATOR

Gangnam Severance Hospital

KICHEOR BAE

Role: PRINCIPAL_INVESTIGATOR

Keimyung University Dongsan Medical Center

YONG IN

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

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Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status

KyungHee University Gangdong Hospital

Seoul, , South Korea

Site Status

Gangnam Severance Hospital

Seoul, , South Korea

Site Status

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

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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BSR-CTph3-JS1_FU

Identifier Type: -

Identifier Source: org_study_id

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