Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis
Key facts
- Where
- Longwood, Miami, New Orleans, and Troy, United StatesSee the 4 sites
- Phase
- Phase 2
Where in United States
- Future Medical ResearchLongwood, United StatesContact: Mayra Abreu, MDTaking people
- South Florida Research Phase I-IVMiami, United StatesContact: Eduardo Viera, MDTaking people
- Delricht Research-Touro Medical CenterNew Orleans, United StatesContact: Patrick Dennis, MDTaking people
- Oakland Medical ResearchTroy, United StatesContact: Jay Sandberg, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Enlivex Therapeutics Ltd.
- Trial code
- NCT07580716
- Record updated
- 13 October 2026
- Original 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).Read full original descriptionShow less
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis
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).
Inclusion: 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: Recent major injury, surgical procedure, or intra-articular treatment in the index knee; Use of medications that may interfere with pain assessment or study outcomes; Known coagulopathy or use of anticoagulant/antiaggregant medication; 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; Significant uncontrolled systemic disease or clinically significant findings on screening laboratory tests or physical examination; 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; Body Mass Index (BMI) >40 kg/m².