Osteoarthritis, KneeNCT05752032
A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo
An observational study of Osteoarthritis, Knee, run by ICM Co. Ltd. at 2 sites in Australia.
Trial summary
This is an observational study of the long term safety and efficacy of ICM-203. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- ICM-203
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesAustralia
- Study dates
- 16 Mar 2023to Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who received ICM-203 or matching placebo in clinical studies
Who may be able to join
- Previous receipt of ICM-203 or matching placebo
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Barwon Health
Geelong, Victoria, 3220
About this study
This is an observational study of the long term safety and efficacy of ICM-203.
Read the detailed description
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
- Osteoarthritis, Knee
- Being tested
- ICM-203, Placebo
- Keywords
- Adeno-associated virus, Gene therapy, ICM-203, Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICM-203Genetic
Long term follow-up
PlaceboDrug
Long term follow-up
| Study group | Role | What they receive |
|---|---|---|
| ICM-203 | Participants who previously received ICM-203 in ICM-203 clinical studies Receives: Genetic: ICM-203 | |
| Placebo | Participants who previously received placebo in ICM-203 clinical studies Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delayed adverse events
Measured: Up to 5 years
Secondary outcomes (5)
Knee pain
Evaluation of change from baseline in knee pain as measured using a Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable)
Measured: Up to 3 years
Knee function
Evaluation of change from baseline in knee function as measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) function in daily living subscale ranging from 0 (extreme problems) to 100 (no problems)
Measured: Up to 3 years
Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS)
Evaluation of change from baseline in MOAKS, focusing on bone marrow lesions, articular cartilage, and effusion-synovitis, where higher scores reflect worse disease
Measured: Up to 3 years
Joint space width
Evaluation of change from baseline in joint space width in mm as measured on knee radiograph
Measured: Up to 3 years
Incidence of total knee replacement
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start16 Mar 2023
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- ICM Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alison Heald, MD, Study director, ICM Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752032
- Sponsor's protocol ID
- ICM 20-1002
- Status last verified
- Sep 2026
- First submitted
- 21 Feb 2023
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo
- ClinicalTrials.gov ID
- NCT05752032
- Acronym / sponsor ID
- ICM 20-1002
- Conditions
- Osteoarthritis, Knee
- Keywords
- Adeno-associated virus, Gene therapy, ICM-203, Osteoarthritis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- ICM Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study of the long term safety and efficacy of ICM-203.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICM-203 | – | Genetic: ICM-203Participants who previously received ICM-203 in ICM-203 clinical studies |
| Placebo | – | Drug: PlaceboParticipants who previously received placebo in ICM-203 clinical studies |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who received ICM-203 or matching placebo in clinical studies
Key inclusion criteria (1 listed)
- Previous receipt of ICM-203 or matching placebo
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICM-203Long term follow-up | Genetic | ICM-203 |
| PlaceboLong term follow-up | Drug | Placebo |
Primary outcome
Incidence of delayed adverse events
Time frame: Up to 5 years
5 secondary outcomes
Knee pain
Time frame: Up to 3 years
Knee function
Time frame: Up to 3 years
Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS)
Time frame: Up to 3 years
Joint space width
Time frame: Up to 3 years
Incidence of total knee replacement
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Heald, MD study director
ICM Co. Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by ICM Co. Ltd. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delayed adverse events (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.