Active — Not RecruitingPhase 1/2

Study of Intra-articular Allocetra in Knee Osteoarthritis

Denmark, Israel160 participantsStarted 2024-01-26

Plain-language summary

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.

Who can participate

Age range45 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. Wheelchair bound.
✕. Immunosuppressive therapy
✕. Any known current or prior tumor of the index knee.
✕. 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.
✕. Body Mass Index (BMI) \>40.

What they're measuring

Treatment-emergent adverse events and Serious adverse events following Allocetra-OTS injection

Timeframe: 7 months following Day 0

Trial details

NCT IDNCT06233474

SponsorEnlivex Therapeutics Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-15

View on ClinicalTrials.gov More Osteoarthritis, Knee trials