CompletedPhase 1/2
Study of Intra-articular Allocetra in Knee Osteoarthritis
Key facts
- Who runs it
- Enlivex Therapeutics Ltd.
- Where
- Denmark, Israel, and Moldova12 sites in 3 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 1/2
- People taking part
- 134 people enrolled
- Started
- 26 Jan 2024
- Ended
- 15 Oct 2026
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Allocetra
- Placebo
- Record updated
- 4 November 2026
Who can take part
- Age
- 45 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- Age 45 - 80 years
- Chronic osteoarthritis of index knee with knee-related joint pain
- Radiographic evidence of knee osteoarthritis of K-L Grade 2 or 3 in the index knee
- Knee pain assessed daily over a period of 7 days during the screening period and following wash-out of pain medications
- Patients with chronic knee pain for at least 3 months who have failed to respond adequately to conventional therapy
- Willing to abstain from other intra-articular treatments and adhere to the protocol restrictions for concomitant medications and therapies during the study
- 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
Who cannot take part
- Immunosuppressive therapy
- Any known current or prior tumor of the index knee
- Any major surgical cartilage treatment within 6 months
- Known coagulopathy, or use of anticoagulation medication or antiaggregant medication
- Any known history or current intra-articular or osseous infection of the index knee
- Any evidence of clinically significant active infection
- Any known history of inflammatory arthropathy or crystal-deposition arthropathy
- Any known severe systemic cartilage and/or bone disorder, such as, but not limited to, chondrodysplasia, osteogenesis imperfecta
- Clinically significant widespread pain syndromes, e.g., fibromyalgia, long COVID syndrome
- certain tumors, severe cardiac, respiratory or hematologic diseases as defined in the protocol
- Wheelchair bound
- Body Mass Index (BMI) >40
- Any ligamentous repair or malalignment correction in the index knee within 6 months
- Major injury to the index knee, such as torn ligament or severe sprain within 6 months
- Clinically relevant knee instability of the index knee
- Severe hip osteoarthritis ipsilateral to the index knee
This trial has no sites in United States.
It has sites in 3 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
This is a double blind, randomized,multi-center study to evaluate the safety and efficacy of intra-articular administration of Allocetra compared to placebo in patients with symptomatic knee osteoarthritis.
The 3 groups in the trial
- Safety run-in phase - Allocetra increasing doseOther group
An open-label dose escalation phase to characterize the safety and tolerability of Allocetra injections to the knee in different doses and select the Allocetra dose and regimen for the randomized phase.
Treatment: Allocetra
- Randomization phase - Placebo.Placebo, for comparison
Three intra-articular injections of placebo into the index knee.
Treatment: Placebo
- Randomization phase - AllocetraTreatment being tested
Three intra-articular injections of Allocetra at a selected dose, into the index knee.
Treatment: Allocetra
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 1/2a Randomized, Double-Blind Placebo-controlled Study of Intra-articular Allocetra in Knee Osteoarthritis
- Record updated
- 4 November 2026