Study of PTP-001 (MOTYS™) for Knee Osteoarthritis
This study is testing a treatment called PTP-001 (MOTYS™) for knee osteoarthritis. PTP-001 is made from human placental tissue and is given as a single injection into the knee. Researchers want to see if it can improve knee pain and function compared to a placebo (a saline injection, which has no active medicine). You might be able to join if you are 40 to 80 years old and have mild to moderate knee osteoarthritis that is the main source of your body pain. The study will measure how many participants show significant improvement in knee function and pain after 6 months. The current status of this study is unclear, and it plans to enroll at least 260 participants.
- Study design
- This is a Phase 3 study where participants are randomly assigned to receive either PTP-001 or a placebo, and neither you nor your doctors will know which you are receiving. At least 260 participants are planned to be enrolled.
- What's involved
- You would have a screening period of up to 28 days, receive a single injection on one day, and then be followed for 12 months after treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after receiving the 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.
A Study to Evaluate the Efficacy and Safey of PTP-001 (MOTYS™) in Knee Osteoarthritis Patients
At a glance
Conditions
NCT07219771
Where you'd take part
This study runs at 17 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Central Research Associates, LLC dba Flourish Research
Birmingham, Alabamastudy coordinator listed
Recruiting
Chicago Clinical Research Institute, Inc.
Chicago, Illinoisstudy coordinator listed
Recruiting
Coastal Carolina Research Center, LLD
North Charleston, South Carolinastudy coordinator listed
Recruiting
Conquest Research, LLC
Winter Park, Floridastudy coordinator listed
Recruiting
Emeritus Research Sydney
Botany, New South Wales, Australiastudy coordinator listed
Recruiting
Focus Clinical Research
West Hills, Californiastudy coordinator listed
Recruiting
Genesis Research Services
Broadmeadow, New South Wales, Australiastudy coordinator listed
Recruiting
Horizon Clinical Research
La Mesa, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Professor David Hunter · PRINCIPAL_INVESTIGATOR · Chair of Rheumatology at University of Sydney and Royal North Shore Hospital
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Proportion of participants meeting strict responder criteria for improvement in knee function.6 months
To qualify as a "strict responder for improvement in knee function", an improvement of ≥ 50% in WOMAC Function subscale score is required, with an absolute change ≥ 20 points in the score.
- Proportion of participants meeting strict responder criteria for improvement in knee pain.6 months
To qualify as a "strict responder for improvement in knee pain", an improvement of ≥ 50% in WOMAC Pain subscale score is required, with an absolute change ≥ 20 points in the score.