Could donor cells ease knee pain without surgery?

NCT ID NCT06208241

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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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