Status:

UNKNOWN

Follow-up Safety and Efficacy Evaluation on Subjects Who Completed Phase I Clinical Trial

Lead Sponsor:

Medipost Co Ltd.

Conditions:

Knee Osteoarthritis

Eligibility:

All Genders

19+ years

Phase:

PHASE1

Brief Summary

This is a follow-up study to investigate the long-term safety and explore efficacy of SMUP-IA-01, for the treatment of Knee Osteoarthritis. Subjects who participated in and completed the initial stage...

Detailed Description

The subjects will be followed up at 6-month, 12-month, 24-month, 36-month, 48-month and 60-month after the initial administration of SMUP-IA-01.

Eligibility Criteria

Inclusion

  • Subject who completed the safety and explore efficacy evaluations in SMUP-IA-01 Phase I clinical trial.
  • Subjects who have been treated with either SMUP-IA-01 at least 6 months ago.
  • Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial.

Exclusion

  • Subjects who were not enrolled in phase 1 clinical trial of SMUP-IA-01 for assessing safety and explore efficacy.
  • Other subjects, excluding those listed above, who were deemed unsuitable by the PI

Key Trial Info

Start Date :

April 14 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT04339504

Start Date

April 14 2020

End Date

December 1 2025

Last Update

March 15 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Seoul national University Hospital

Seoul, Jongno-gu, South Korea, 03080