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A phase I/IIa, prospective, mono-center, double-blinded, randomized, controlled study to assess the safety and efficacy of applying PLX-PAD cells for the treatment of mild to moderate knee osteoarthritis - PROTO
EU CTIS ID: 2023-504212-15-00
What this study is testing
To assess the safety and tolerability of local injections of PLX-PAD into the IA space and the periarticular muscle, for the treatment of mild to moderate knee OA.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed written informed consent prior to initiation of any trial related measure.
- Adult patients (f/m), 50 to 80 years old at the time of the screening visit
- Symptomatic mild to moderate OA of the index knee as defined by the OARSI-Joint Space Narrowing (JSN) Score of 1or 2 (standing Rosenberg AP x-ray)
- Pain in the index knee of 8-18 on the WOMAC pain score (reporting the last 48 hours, respectively at week 4 and week 1 before inclusion) after washout of at least 5 half-lives of previously taken NASAIDs medication(s)
- Failed conservative treatment, indicated by Pain in the index knee ≥ 3 months due to OA
You likely can't join if
- Arthroscopy to the index knee within the last 12 months as well as surgery to other weight-bearing joints, that may interfere with index knee assessments
- Prior reconstructive cartilage transplantation or resurfacing procedures to the index knee
- Knee instability of clinical relevance such as lateral, medial or cruciate ligament instabilities that compromise patient during walking at time of screening
- Patients having received OA knee injection therapy (such as PRP, MSCs, or Hyaluronic Acid) in the last six months before screening
- Rheumatologic inflammatory arthropathies
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.