NCT07580716 · Enlivex Therapeutics Ltd.
Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis
What this study is about
This is a conducted at multiple hospitals, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, Phase IIb study to evaluate intra-articular (IA) injections of Allocetra in participants with moderate-to-severe age related symptomatic primary knee osteoarthritis (OA).
View original scientific description
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).
Interventions
DRUG
Allocetra
Allocetra is a cell-based therapy consisting of non-HLA-matched allogeneic peripheral blood mononuclear cells, induced to an apoptotic stable state.
OTHER
Placebo
The control used in this study will be placebo. Placebo solution containing all excipients except for the Allocetra cells.
Primary outcome measures
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain score at 3 months
Time frame: 3 months.
The change from baseline of the WOMAC Pain score at 3 months between Allocetra and Placebo. Total Pain score ranges from 0 (No pain) to 50 (Extreme pain).
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function score at 3 months
Time frame: 3 months.
The change from baseline for the WOMAC Function score at 3 months between Allocetra and Placebo. Total Function score ranges from 0 (No difficulty) to 170 (Extreme difficulty).
Primary Safety Endpoint
Time frame: Day 0 to 6 months.
Incidence and severity of Adverse Events (AEs) up to 6 months. AE incidence will be represented as % per study group and AE severity will be represented as mild, moderate or severe.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Longwood, Florida
- Miami, Florida
- New Orleans, Louisiana
- Troy, Michigan
Collaborators
Nordic Bioscience Clinical Development (NBCD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2026 · Source of record for eligibility and locations