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

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

Recruiting
19 years and older
All
Phase 1

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Overview

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 of the Phase I trial (NCT04037345 ) will be followed-up until 60 months.

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Study details
    Knee Osteoarthritis

NCT04339504

Medipost Co Ltd.

25 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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