Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Primary Knee Osteoarthritis

In brief

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).

Key facts

Study ID

NCT07580716

Run by

Enlivex Therapeutics Ltd.

People needed

270

Starts

2026-05-01

Expected to finish

2028-04-01

Last updated by the study team

2026-06-17

Who can join

Age: 64 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet all of the inclusion criteria listed below to be eligible for the study:
• Age 64 years or above.
• Diagnosis of primary femorotibial knee OA.
• Radiographic evidence of knee OA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the index knee.
• Participants who are intolerant to, or have failed to adequately respond to at least 2 OA therapies.
• Index knee pain assessed during the screening period and following wash-out of pain medications.
• Willingness to abstain from prohibited medications/treatments during the trial.
• Women who are postmenopausal (≥12 months natural amenorrhea without alternative cause) or surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
• Male participants with partners of childbearing potential, who are not surgically sterile (vasectomy) for at least 6 months prior to randomization, must use condoms with spermicide in addition to their partner's contraception from randomization and for 90 days after last dose.

You may not qualify if…

• Participants will be excluded from the study if they meet any of the following criteria:
• Severe or end-stage osteoarthritis of the index knee.
• Clinically significant structural abnormalities or instability of the index knee.
• Recent major injury, surgical procedure, or intra-articular treatment in the index knee.
• Any known history of infection or tumor of the index knee, or active infection at the intended injection site.
• Any known history of inflammatory arthropathy or crystal-deposition disease.
• Any severe systemic cartilage, bone, or musculoskeletal disorder that may interfere with study outcomes.
• Clinically significant widespread pain syndromes.
• Immunosuppressive therapy, clinically significant immunodeficiency, or active infection.
• Body Mass Index (BMI) >40 kg/m²
• Use of medications that may interfere with pain assessment or study outcomes.
• Known coagulopathy or use of anticoagulant/antiaggregant medication.
• Significant uncontrolled systemic disease or clinically significant findings on screening laboratory tests or physical examination.

Where it is running

• Future Medical Research — Longwood, Florida, United States (enrolling)
• South Florida Research Phase I-IV — Miami, Florida, United States (enrolling)
• DelRicht Research @ Touro Medical Center — New Orleans, Louisiana, United States (enrolling)
• Oakland Medical Research — Troy, Michigan, United States (enrolling)
• Sanos Clinic Gandrup — Gandrup, Denmark (enrolling)
• Sanos Clinic Herlev — Herlev, Denmark (enrolling)
• Sanos Clinic Vejle — Vejle, Denmark (enrolling)
• NZOZ Bif-Med. s.c — Bytom, Poland
• Vita Longa Sp. z o.o. — Katowice, Poland
• Centrum Medyczne PLEJADY — Krakow, Poland
• Medyczne Centrum Hetmańska — Poznan, Poland
• Reumedika sp. z o.o. — Poznan, Poland
• DC-MED Michal Kowalski S.K. Radom — Radom, Poland
• DC-MED Michal Kowalski S.K. Swidnica — Swidnica, Poland
• Etg Justmed — Warsaw, Poland
• Etg Warszawa — Warsaw, Poland
• Migre Polskie Centrum — Wroclaw, Poland

Full record on ClinicalTrials.gov

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