Status:
ACTIVE_NOT_RECRUITING
Use of Allocetra-OTS in End Stage Knee Osteoarthritis - Assessment of Safety
Lead Sponsor:
Amir Oron
Collaborating Sponsors:
Enlivex Therapeutics Ltd.
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This is a pilot study to assess safety and possible efficacy of Allocetra-OTS in end-stage knee osteoarthritis.
Eligibility Criteria
Inclusion
- Age 18 or older.
- Diagnosed with end-stage knee osteoarthritis and are scheduled or offered surgery.
- X-ray positive for knee osteoarthritis.
- Pain and functional disability from osteoarthritis.
- Acceptable blood workup results (CBC, electrolytes, kidney and liver function) from up to three months before treatment.
- Mentally and physically able to fully comply with the study protocol.
- Signed Informed Consent form.
Exclusion
- Evidence of active local infection in the vicinity of the knee joint.
- Previous surgery of total or partial knee replacement in the injected knee.
- Patients unable to provide informed consent due to language barrier or mental status.
- Patients with a major medical condition that would affect quality of life and influence the results of the study.
- Patients unwilling to be followed for the duration of the study.
- Acute infection requiring intravenous antibiotics at the time of screening.
- Other limb pain of unknown etiology.
- Pain in the limb clinically assessed to arise from an origin which is not the affected knee joint.
- Known neurological disease or rheumatic condition other than osteoarthritis.
- Bleeding disorders.
- Known cognitive disorder.
- Concurrent participation in any other clinical study. Participation in an interventional investigational study within 30 days prior to enrollment.
- Physician objection.
- Positive pregnancy test.
Key Trial Info
Start Date :
July 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06208241
Start Date
July 12 2023
End Date
December 30 2025
Last Update
August 5 2025
Active Locations (1)
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1
Kaplan Medical Center
Rehovot, Israel