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Could donor cells ease knee pain without surgery?
NCT ID NCT06208241
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This early-phase trial tests the safety of Allocetra-OTS, a cell therapy made from donor immune cells, injected into the knee joint of 18 people with end-stage osteoarthritis who are candidates for surgery. Researchers will monitor side effects and measure pain relief using a standard pain scale. The study is not yet recruiting and focuses on safety first.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Allocetra-OTS (a cell therapy made from donor immune cells)
- What this could lead to
- If safe and effective, this could point toward a new non-surgical option for severe knee osteoarthritis pain.
- What could go wrong
- This is a very early, small pilot study with only 18 people, so results may not apply widely. The main goal is safety, not proof of effectiveness.
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
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2023
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- 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. Age 18 or older. 2. Diagnosed with end-stage knee osteoarthritis and are scheduled or offered surgery. 3. X-ray positive for knee osteoarthritis. 4. Pain and functional disability from osteoarthritis. 5. Acceptable blood workup results (CBC, electrolytes, kidney and liver function) from up to three months before treatment. 6. Mentally and physically able to fully comply with the study protocol. 7. Signed Informed Consent form. Exclusion Criteria: 1. Evidence of active local infection in the vicinity of the knee joint. 2. Previous surgery of total or partial knee replacement in the injected knee. 3. Patients unable to provide informed consent due to language barrier or mental status. 4. Patients with a major medical condition that would affect quality of life and influence the results of the study. 5. Patients unwilling to be followed for the duration of the study. 6. Acute infection requiring intravenous antibiotics at the time of screening. 7. Other limb pain of unknown etiology. 8. Pain in the limb clinically assessed to arise from an origin which is not the affected knee joint. 9. Known neurological disease or rheumatic condition other than osteoarthritis. 10. Bleeding disorders. 11. Known cognitive disorder. 12. Concurrent participation in any other clinical study. Participation in an interventional investigational study within 30 days prior to enrollment. 13. Physician objection. 14. Positive pregnancy test.
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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.
Contacts and locations
Locations
-
Kaplan Medical Center
Rehovot, Israel
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Other studies related to the condition(s) this trial covers.
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