New gene shot could regrow knee cartilage and ease arthritis pain
NCT ID NCT05454566
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This early-phase study tests a single injection of ICM-203, a gene therapy that delivers a gene to promote cartilage growth and reduce inflammation in the knee. About 18 adults with mild to moderate knee osteoarthritis will receive escalating doses to check safety and whether it improves pain and function. The goal is to see if this approach can control the disease and ease symptoms.
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.
- Expected to start
-
Nov 2026
An estimate. Start dates often move.
- Expected to finish
-
Nov 2028
An estimate. End dates often move.
- 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 Hide 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), at the time of screening. 4. KOOS function in daily living score \>25, a measure of knee function ranging from 0 (extreme problems) to 100 (no problems), at the time of screening . 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 or psychiatric condition that, in the opinion of the Investigator, would make the subject unsuitable for the study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Osteoarthritis, knee are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Which anesthesia gets joint replacement patients moving sooner?
- Can a special MRI match CT for spotting knee bone damage?
- Can a common bleeding drug make knee realignment surgery safer?
- One shot, new knee? gene therapy trial aims to quiet arthritis pain
- Three knee shots go Head-to-Head for lasting arthritis relief
- Gel shot vs standard injection: which quiets arthritic knees?