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New knee shot aims to ease arthritis pain without surgery

NCT ID NCT06233474

Symptom relief Sponsor: Enlivex Therapeutics 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 · Last updated Jun 27, 2026

Summary

This study tests a new medicine called Allocetra for people with knee osteoarthritis. It is injected directly into the knee joint to see if it safely reduces pain and improves function. About 160 adults aged 45-80 with moderate knee arthritis will receive either Allocetra or a placebo. The goal is to measure pain relief and any side effects over 6 months.

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

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

May 2026

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

45 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. Age 45 - 80 years. 2. Chronic osteoarthritis of index knee with knee-related joint pain 3. Radiographic evidence of knee osteoarthritis of K-L Grade 2 or 3 in the index knee. 4. Knee pain assessed daily over a period of 7 days during the screening period and following wash-out of pain medications 5. Patients with chronic knee pain for at least 3 months who have failed to respond adequately to conventional therapy. 6. Willing to abstain from other intra-articular treatments and adhere to the protocol restrictions for concomitant medications and therapies during the study. 7. Women of childbearing potential and all men must agree to use 2 methods of an adequate contraception prior to study entry and for the duration of study participation through 4 weeks following IP administration. Exclusion Criteria: 1. Wheelchair bound. 2. Immunosuppressive therapy 3. Any known current or prior tumor of the index knee. 4. Any known history or current intra-articular or osseous infection of the index knee. 5. Any evidence of clinically significant active infection 6. Any known history of inflammatory arthropathy or crystal-deposition arthropathy 7. Any known severe systemic cartilage and/or bone disorder, such as, but not limited to, chondrodysplasia, osteogenesis imperfecta. 8. Body Mass Index (BMI) \>40. 9. Any major surgical cartilage treatment within 6 months 10. Any ligamentous repair or malalignment correction in the index knee within 6 months 11. Major injury to the index knee, such as torn ligament or severe sprain within 6 months 12. Clinically relevant knee instability of the index knee 13. Severe hip osteoarthritis ipsilateral to the index knee. 14. Clinically significant widespread pain syndromes, e.g., fibromyalgia, long COVID syndrome. 15. Known coagulopathy, or use of anticoagulation medication or antiaggregant medication;. 16. certain tumors, severe cardiac, respiratory or hematologic diseases as defined in the protocol

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Conditions

The condition(s) this trial relates to.

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

  • Barzilai Medical Center

    Ashkelon, 7830604, Israel

  • Hasharon Medical Center

    Petah Tikva, 4937211, Israel

  • IMSP Institutul de Cardiologie

    Chisinau, 2025, Moldova

  • IMSP Sptalul Clinic Municipal "Sfanta Treime"

    Chisinau, 2068, Moldova

  • Ichilov - Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • Kaplan Medical Center

    Rehovot, 7661041, Israel

  • Rambam Medical Center

    Haifa, 7651211, Israel

  • Sanos Clinic Herlev

    Herlev, 2730, Denmark

  • Sanos Clinic Nordjylland

    Gandrup, 9362, Denmark

  • Sanos Clinic Syddanmark

    Vejle, 7100, Denmark

  • Sheba Medical Center

    Ramat Gan, 5266202, Israel

  • Spitalul Clininc Republican "T. Mosneaga"

    Chisinau, 2025, Moldova

More trials for these conditions

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