RecruitingPrimary Knee Osteoarthritis
Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis
Eligible age
64+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
This is a multicenter, randomized, double-blind, placebo-controlled, Phase IIb study to evaluate intra-articular (IA) injections of Allocetra in participants with moderate-to-severe age related symptomatic primary knee osteoarthritis (OA).
Sponsor: Enlivex Therapeutics Ltd.
You may qualify if…
- ✓ Participants must meet all of the inclusion criteria listed below to be eligible for the study:
- ✓ 1. Age 64 years or above.
- ✓ 2. Diagnosis of primary femorotibial knee OA.
- ✓ 3. Radiographic evidence of knee OA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the index knee.
- ✓ 4. Participants who are intolerant to, or have failed to adequately respond to at least 2 OA therapies.
- ✓ 5. Index knee pain assessed during the screening period and following wash-out of pain medications.
- ✓ 6. Willingness to abstain from prohibited medications/treatments during the trial.
- ✓ 7. Women who are postmenopausal (≥12 months natural amenorrhea without alternative cause) or surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
You may not qualify if…
- ✕ Participants will be excluded from the study if they meet any of the following criteria:
- ✕ 1. Severe or end-stage osteoarthritis of the index knee.
- ✕ 2. Clinically significant structural abnormalities or instability of the index knee.
- ✕ 3. Recent major injury, surgical procedure, or intra-articular treatment in the index knee.
- ✕ 4. Any known history of infection or tumor of the index knee, or active infection at the intended injection site.
- ✕ 5. Any known history of inflammatory arthropathy or crystal-deposition disease.
- ✕ 6. Any severe systemic cartilage, bone, or musculoskeletal disorder that may interfere with study outcomes.
- ✕ 7. Clinically significant widespread pain syndromes.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07580716 · last updated 2026-06-17