Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis (NCT07580716) | Clinical Trial Compass
RecruitingPhase 2
Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis
United States, Denmark, Poland270 participantsStarted 2026-05-01
Plain-language summary
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).
Who can participate
Age range
64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Severe or end-stage osteoarthritis of the index knee.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial testing a treatment called Allocetra injected directly into the knee, what does that phase mean for how much is already known about its safety and whether it actually reduces pain compared to standard options like corticosteroid injections or physical therapy?
2The trial is measuring my pain and physical function using the WOMAC score at 3 months — if my scores don't improve by then, what would my next treatment options look like, and would participating in this trial delay or limit access to those alternatives?
3There's a dedicated primary safety endpoint being tracked — what kinds of side effects or risks have been observed with intra-articular injections of cell-based therapies like Allocetra, and are there any risks specific to injecting this directly into my knee joint that I should weigh carefully?
4Given that this trial is specifically for primary knee osteoarthritis, how would you assess whether the severity and stage of my knee OA fits what this study is designed to evaluate, or whether I might be better served by an established treatment first?
5Since the trial is currently recruiting, how many visits or injections would I need to commit to, and is there anything about the schedule or follow-up requirements that might be difficult to manage alongside my daily life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain score at 3 months
Timeframe: 3 months.
2
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function score at 3 months