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Can a single gene shot rebuild Worn-Out knees?

NCT ID NCT04875754

Disease control Sponsor: ICM Biotech Australia Pty Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This trial tests whether a single injection of ICM-203, a gene therapy, can safely help people with mild-to-moderate knee osteoarthritis. The therapy delivers a gene into the knee joint that may encourage cartilage growth, reduce inflammation and pain, and improve daily movement. Researchers will give escalating doses to a small group of participants and compare against a placebo to check safety and early signs of benefit.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ICM-203, a gene therapy injected into the knee that carries instructions to promote cartilage formation and reduce inflammation
What this could lead to
If it works, a single injection could slow or reverse knee osteoarthritis damage, offering lasting pain relief and better joint function without daily medication.
What could go wrong
This is an early, small trial focused on safety, so the gene therapy may not improve symptoms or could cause side effects like joint irritation. Success in a dozen people may not predict broader results.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

12 people

The number who actually took part.

Started

Mar 2022

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive, at the time of screening. 2. Kellgren-Lawrence grade 2 or grade 3 OA of target knee. 3. Target knee pain between 4 and 9, inclusive, on an NRS ranging from 0 (no pain) to 10 (worst pain imaginable). 4. KOOS function in daily living score \>25, a measure of knee function ranging from 0 (extreme problems) to 100 (no problems). 5. A stable treatment regimen for symptomatic relief of OA, including NSAIDs, for 4 weeks prior to screening. Exclusion Criteria: 1. History of rheumatoid arthritis, psoriatic arthritis, gout, pseudogout, autoimmune OA, chondrocalcinosis, hemochromatosis, villonodular synovitis, and synovial chondromatosis or other disorder that in the opinion of the Investigator could cause inflammation of the knee. 2. Injection of steroid, hyaluronate or other agent, into the target knee less than 90 days prior to day 1. 3. Major injury to the target knee, such as torn ligament or severe sprain, within 12 months of screening. 4. Disability so severe that the subject cannot comply with the study requirements, including knee symptoms that result in significant difficulty or inability to walk. 5. Surgery on the target knee within 180 days prior to day 1 6. Total knee arthroplasty or other knee surgery planned in the next 12 months. 7. Active joint infection or other concurrent medical (diabetes, uncontrolled hypertension, severe osteoporosis, glaucoma) or psychiatric condition that, in the opinion of the Investigator, would make the subject unsuitable for the study.

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Conditions

The condition(s) this trial relates to.

osteoarthritis osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoarthritis,knee

Contacts and locations

Locations

  • Barwon Health

    Geelong, Victoria, 3220, Australia

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

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