A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo

NCT ID: NCT05752032

Last Updated: 2024-10-15

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

ENROLLING_BY_INVITATION

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-16

Study Completion Date

2028-12-31

Brief Summary

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This is an observational study of the long term safety and efficacy of ICM-203.

Detailed Description

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Subjects who have received ICM-203 or matching placebo from ICM-203 clinical studies will be enrolled. Subjects will be contacted annually to collect safety and efficacy outcomes until 5 years after the last dose of ICM-203 or placebo.

Conditions

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Osteoarthritis, Knee

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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ICM-203

Participants who previously received ICM-203 in ICM-203 clinical studies

ICM-203

Intervention Type GENETIC

Long term follow-up

Placebo

Participants who previously received placebo in ICM-203 clinical studies

Placebo

Intervention Type DRUG

Long term follow-up

Interventions

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ICM-203

Long term follow-up

Intervention Type GENETIC

Placebo

Long term follow-up

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Previous receipt of ICM-203 or matching placebo

Exclusion Criteria

* None
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ICM Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alison Heald, MD

Role: STUDY_DIRECTOR

ICM Co. Ltd.

Locations

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Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

Barwon Health

Geelong, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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ICM 20-1002

Identifier Type: -

Identifier Source: org_study_id

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