Study on Autologous Chondrocytes and Remestemcel for Knee Cartilage Lesions in Patients with Symptomatic Articular Cartilage Damage

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What is this study about?

This clinical trial is focused on studying a condition known as articular cartilage lesions of the knee. These lesions occur when the smooth cartilage that covers the ends of bones in the knee joint is damaged, leading to pain and difficulty in movement. The study is investigating a new treatment called the Instant MSC Product accompanying Autologous Chondron Transplantation (IMPACT). This treatment involves using a special paste made from a patient’s own cartilage cells, known as autologous chondrocytes, and a type of stem cell called remestemcel. The paste is applied directly to the damaged area in the knee through an injection.

The purpose of the study is to compare the effectiveness of the IMPACT treatment with standard care, which may include physical therapy and pain medication, but not surgery. Participants in the study will be randomly assigned to receive either the IMPACT treatment or the standard care. The study will follow participants over a period of 9 months to assess improvements in their knee function and overall quality of life. Participants will have check-ups at 3, 6, and 9 months to monitor their progress.

In addition to evaluating improvements in knee function and quality of life, the study will also look at how well the knee structure repairs itself after treatment. This will be done using MRI scans at 6 and 18 months after the treatment. The study aims to provide valuable information on whether the IMPACT treatment can offer better outcomes for patients with knee cartilage damage compared to the current standard care options.

1 joining the study

Upon joining the study, you will be asked to provide written informed consent. This means you agree to participate and understand the study requirements.

You must be between 18 and 45 years old and have a symptomatic articular cartilage lesion of the knee.

2 randomization

You will be randomly assigned to one of two groups: one receiving the IMPACT treatment and the other receiving standard care.

Standard care may include optional physical therapy and pain medication, but no surgical treatment.

3 treatment phase

If you are in the IMPACT group, you will receive an intra-articular injection of the Instant MSC Product in the form of an implantation paste.

The treatment aims to improve the condition of your knee cartilage.

4 follow-up visits

You will have follow-up visits at 3, 6, and 9 months after the treatment to assess clinical improvement and quality of life.

These assessments will use specific questionnaires to measure your progress.

5 secondary assessments

At 6 and 18 months after treatment, additional assessments will be conducted using MRI scans to examine the structural repair of your knee.

Who Can Join the Study?

Have a symptomatic articular cartilage lesion of the knee. This means you have a problem with the smooth tissue at the end of your knee bones, causing symptoms like pain or swelling.
Be between the ages of 18 and 45 years old.
Be able to provide written informed consent. This means you understand the study and agree to participate, including attending follow-up visits and completing questionnaires.
Have a Modified Outerbridge Grade III or IV isolated cartilage lesion of the knee. This refers to a specific level of damage to the cartilage in your knee.
Have a cartilage lesion size of more than 2 cm² and up to 8 cm² after any cleaning or smoothing of the area.
Have at least 50% of functional meniscus remaining. The meniscus is a part of your knee that helps with movement and cushioning. If needed, it can be repaired or partially removed during surgery, but at least half must remain functional.
Have stable knee ligaments. This means the main ligaments in your knee, like the anterior and posterior cruciate ligaments, are not damaged or loose.

Who Cannot Join the Study?

Patients with a symptomatic articular cartilage lesion of the knee, which means they have noticeable symptoms from damage to the smooth tissue covering the ends of bones in the knee joint.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who are not able to follow the study procedures or attend follow-up visits.
Patients who have other medical conditions that might interfere with the study or its results.
Patients who are currently participating in another clinical trial.
Patients who have had recent surgery on the knee or are planning to have surgery during the study period.
Patients who are pregnant or planning to become pregnant during the study.
Patients who have allergies or reactions to the study treatment or its components.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.11.2024

Trial locations

Investigated drugs:

Instant MSC Product is a type of therapy that uses special cells called mesenchymal stem cells (MSCs). These cells are taken from your own body and are used to help repair damaged cartilage in your knee. The goal of this therapy is to improve the healing process and help your knee function better, potentially reducing pain and improving your quality of life.

Autologous Chondron Transplantation is a procedure where healthy cartilage cells from your own body are used to repair damaged areas in your knee. These cells are collected, sometimes grown in a lab, and then placed into the damaged area to help it heal. This therapy aims to restore the normal function of your knee by using your body’s own cells.

Pain Medication refers to drugs that are used to relieve pain. In this trial, pain medication is part of the standard care for patients who are not receiving the new therapies. These medications help manage pain and discomfort in the knee, allowing you to continue with daily activities more comfortably.

Physical Therapy is a treatment that involves exercises and movements to help improve the strength and flexibility of your knee. It is part of the standard care for patients in the trial who are not receiving the new therapies. Physical therapy aims to improve your knee’s function and reduce pain through guided exercises and techniques.

Investigated diseases:

Chondropathy

Symptomatic articular cartilage lesion of the knee – This condition involves damage to the cartilage in the knee joint, specifically on the femoral condyles or the trochlea. Cartilage is a smooth, rubbery tissue that covers the ends of bones in joints, allowing them to move smoothly against each other. When this cartilage is damaged, it can lead to pain, swelling, and reduced movement in the knee. Over time, the lesion may worsen, potentially leading to more significant joint issues. The progression of symptoms can vary, with some individuals experiencing gradual worsening, while others may have periods of stability. The condition can affect daily activities and quality of life due to discomfort and limited mobility.

Trial ID:

2024-514612-27-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Autologous Chondrocytes and Remestemcel for Knee Cartilage Lesions in Patients with Symptomatic Articular Cartilage Damage

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?