Allocetra for Primary Knee Osteoarthritis
This study is testing a cell-based therapy called Allocetra for people with moderate-to-severe primary knee osteoarthritis (OA). Allocetra uses specially prepared immune cells to help reduce inflammation in the knee. You might be able to join if you are 64 or older, have a diagnosis of primary knee OA with specific X-ray findings (Kellgren-Lawrence grade 2 or 3), and haven't responded well to at least two other OA treatments. The study will compare Allocetra to a placebo (a look-alike substance with no active drug) to see if Allocetra can improve pain and function in your knee. We will measure your pain and function using a score called WOMAC at 3 months, and also track your safety for up to 6 months. The current status of this study is unclear.
- Study design
- This is a randomized, double-blind, placebo-controlled Phase IIb study involving 270 participants. You would be randomly assigned to receive either Allocetra or a placebo.
- What's involved
- You would receive three injections into your knee (on Day 0, Day 14, and Day 28).
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for 12 months after your treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis
At a glance
Conditions
Where it's being run
17 sites across 5 statesStudy leadership
- Lital Weinfeld Bergman · STUDY_DIRECTOR · Senior Director of Clinical Operations
Who to contact
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What this trial measures
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain score at 3 months3 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 months3 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 EndpointDay 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.