Study on the Safety and Effectiveness of PLX-PAD Cells for Patients with Mild to Moderate Knee Osteoarthritis

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What is this study about?

This clinical trial is focused on studying the treatment of knee osteoarthritis, a condition that causes pain and stiffness in the knee joint. The treatment being tested is called PLX-PAD, which involves injecting special cells known as placental adherent stromal cells into the knee area. These cells are a type of cell therapy that may help reduce symptoms of osteoarthritis. The study will also use a placebo, which looks like the treatment but does not contain the active cells, to compare the effects.

The purpose of the study is to assess the safety and effectiveness of the PLX-PAD treatment for people with mild to moderate knee osteoarthritis. Participants will receive injections and be monitored over time to see how their symptoms change. The study will include regular check-ups and assessments, such as imaging tests like MRI to look at the knee joint, and questionnaires to evaluate pain and quality of life. The study will last several years, with follow-up visits to track long-term effects.

In addition to the main treatment, the study will also involve the use of cetirizine dihydrochloride, a medication commonly used for allergies, to help manage any potential allergic reactions during the trial. Participants will be closely monitored for any side effects or changes in their condition throughout the study. The goal is to gather information that could lead to new treatment options for knee osteoarthritis in the future.

1 joining the study

Upon joining the study, the patient must provide signed written informed consent. This is a document that confirms understanding and agreement to participate in the trial.

2 initial assessment

The patient undergoes an initial assessment to confirm eligibility. This includes being between 50 to 80 years old and having mild to moderate knee osteoarthritis, as determined by specific criteria.

3 baseline measurements

Baseline measurements are taken, including the WOMAC pain score, which evaluates pain in the knee. Additional assessments include MRI scans to evaluate joint synovitis, effusion, and cartilage condition.

4 treatment administration

The patient receives local injections of PLX-PAD cells into the knee area. This treatment aims to assess safety and tolerability for knee osteoarthritis.

5 follow-up assessments

Follow-up assessments occur at various intervals: weeks 1, 4, 12, 26, 52, 104, and 156. These include evaluations of pain scores, joint condition via MRI, and quality of life measures.

6 safety monitoring

Throughout the trial, safety is monitored by assessing any adverse events, such as allergic reactions or joint reactions. The severity and seriousness of these events are evaluated.

7 efficacy evaluation

The primary efficacy endpoint is the change in the WOMAC pain score at week 26 compared to the baseline. Additional assessments include changes in joint condition and function over time.

8 exploratory endpoints

Exploratory endpoints include evaluations of pain medication use, genetic profiling, and biomarker analysis in blood, urine, and synovial fluid. These are conducted at various points throughout the trial.

9 trial completion

The trial is estimated to conclude by October 31, 2028. Final assessments will be conducted to evaluate the long-term effects and safety of the treatment.

Who Can Join the Study?

You must sign a written informed consent form before starting any part of the trial. This means you agree to participate and understand what the trial involves.
You need to be an adult between the ages of 50 and 80 at the time of the screening visit.
You should have mild to moderate osteoarthritis (OA) in your knee. This is determined by a specific score called the OARSI-Joint Space Narrowing (JSN) Score, which should be 1 or 2. This score is based on an x-ray of your knee.
You must have knee pain with a score between 8 and 18 on the WOMAC pain score. This score measures your pain over the last 48 hours and is checked at specific times before joining the trial. You should not have taken certain pain medications, called NSAIDs, for a period that allows them to clear from your body.
You should have tried other treatments for your knee pain, but they did not work. This means you have had knee pain for at least 3 months due to osteoarthritis.

Who Cannot Join the Study?

Patients with severe knee problems beyond mild to moderate levels cannot participate.
Individuals who have had recent surgery on the knee area are not eligible.
People with active infections in the knee or surrounding areas are excluded.
Participants with a history of allergic reactions to similar treatments are not allowed.
Those currently participating in another clinical trial cannot join this study.
Pregnant or breastfeeding women are not eligible to participate.
Individuals with certain medical conditions that could interfere with the study are excluded.
Patients who are unable to follow the study procedures or attend follow-up visits are not eligible.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	15.01.2024

Trial locations

Investigated drugs:

PLX-PAD is a type of cell therapy being studied for its potential to treat mild to moderate knee osteoarthritis. It involves injecting these cells into the joint space and surrounding muscle to see if they can help reduce symptoms and improve joint function. The study aims to determine if this treatment is safe and well-tolerated by patients.

Osteoarthritis – Osteoarthritis is a common joint disorder characterized by the breakdown of cartilage, which is the protective tissue at the ends of bones. As the cartilage wears down, bones may begin to rub against each other, leading to pain, swelling, and reduced joint movement. Over time, the joint may lose its normal shape, and bone spurs may develop. The condition typically progresses slowly, with symptoms worsening over the years. It most commonly affects the knees, hips, hands, and spine. Factors such as age, joint injury, and obesity can increase the risk of developing osteoarthritis.

Trial ID:

2023-504212-15-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of PLX-PAD Cells for Patients with Mild to Moderate Knee Osteoarthritis

What is this study about?

Who Can Join the Study?

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