Study on the Effectiveness of Lenzumestrocel for Treating Knee Cartilage Defects in Patients

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What is this study about?

This clinical trial is focused on studying the treatment of knee cartilage defects, which are injuries or damage to the smooth tissue that covers the ends of bones in the knee joint. The treatment being tested involves the use of a special type of cell therapy called lenzumestrocel, also known as BiCure ortho MSCp. These are stem cells derived from a patient’s own bone marrow, which are then expanded and used to help repair the damaged cartilage. The study aims to compare the effectiveness of this treatment when combined with a procedure called microfracture, which involves creating small holes in the bone to stimulate healing, and a 3D scaffold, which is a structure that supports the growth of new tissue.

The purpose of the study is to determine if the combination of microfracture, lenzumestrocel, and the 3D scaffold is more effective than using the microfracture and scaffold alone. Participants in the study will undergo surgery to treat their knee cartilage defects and will be monitored over a period of time to assess their recovery and the improvement in their knee function. The study will involve regular check-ups and assessments, including evaluations of knee function and pain levels, as well as imaging tests like MRI and X-rays to observe the healing process.

Throughout the study, participants will be observed for any side effects or adverse events related to the treatment. The study will last for several months, with key assessments taking place at different intervals, such as 3, 6, 12, and 24 months after the surgery. This will help researchers understand the long-term benefits and safety of using lenzumestrocel in treating knee cartilage defects.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of knee cartilage defect, and preoperative health status.

Written informed consent is required to participate.

2 preparation for surgery

Preparation involves scheduling an open knee surgery to manage the cartilage defect.

The procedure includes microfracture of the subchondral bone followed by the application of a 3D scaffold.

3 surgery and treatment

During surgery, a combination of conventional microfracture and autologous mesenchymal stem cells (MSC) seeded onto the acellular 3D scaffold is used.

The treatment aims to repair the knee cartilage defect.

4 post-operative care and monitoring

Post-operative care includes regular monitoring of knee function and pain levels.

Assessments are conducted at 6 weeks, 3, 6, 12, and 24 months post-operation using the Lysholm knee function score, KOOS value, and VAS for pain.

5 imaging evaluations

X-ray and MRI evaluations are performed at 12 and 24 months post-operation to assess the condition of the knee.

6 final assessment

The final assessment occurs at 24 months post-operation, comparing the changes in knee function, pain, and imaging results between different study groups.

Who Can Join the Study?

Adults between the ages of 18 and 55 can participate.
Participants must be able to provide written consent, which means they agree to join the study after understanding what it involves.
Participants need to have a confirmed diagnosis of a chondral defect in the knee. This means there is damage to the cartilage in the knee joint.
The knee condition should not be more severe than stage II knee osteoarthrosis. This is a way to describe the level of wear and tear in the knee joint.
The cause of the knee defect should be either an injury or early signs of wear and tear.
The defect must be located in the weight-bearing part of the femoral condyle, which is a part of the thigh bone that helps form the knee joint.
Participants should be scheduled for a specific type of knee surgery that involves a procedure called microfracture and the use of a 3D scaffold. This is a treatment to help repair the cartilage.
The knee defect should be isolated, meaning it is the only problem area, and it should not be larger than 6 square centimeters.
Participants should not have had previous knee surgery for treating a chondral defect.
Before surgery, participants need to have a hemoglobin level of at least 110 grams per liter. Hemoglobin is a protein in red blood cells that carries oxygen.
Participants also need a platelet count higher than 150,000 per milliliter. Platelets are cells that help with blood clotting.
Female participants who are sexually active and not sterile must use highly effective birth control throughout the study.

Who Cannot Join the Study?

Patients with a history of severe allergies or allergic reactions to medical treatments.
Individuals who have had previous surgery on the knee that is being studied.
Patients with active infections in the knee area.
Individuals with a history of cancer in the last five years.
Patients who are pregnant or breastfeeding.
Individuals with autoimmune diseases, which are conditions where the body’s immune system attacks its own tissues.
Patients taking medications that suppress the immune system, which are drugs that reduce the body’s ability to fight infections and diseases.
Individuals with blood clotting disorders, which are conditions that affect the blood’s ability to form clots.
Patients with uncontrolled diabetes, a condition where blood sugar levels are too high.
Individuals with severe heart disease, which affects the heart’s ability to pump blood effectively.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Krajska zdravotni a.s.	Teplice	Czechia
Kdruqgu zbvvhdqhd apso &gsbpef Mvygtdmndb nwhuzgsil Úcra nsd Lwzjtb olha	Usti Nad Labem	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	01.09.2020

Trial locations

Investigated drugs:

Lenzumestrocel

Autologous Bone Marrow-Derived Mesenchymal Stem Cells are special cells taken from a patient’s own bone marrow. These cells have the ability to develop into different types of cells, including those that can help repair damaged cartilage in the knee. In this trial, these stem cells are used to see if they can improve healing when applied to a 3D scaffold.

3D Scaffold is a structure used to support the growth of new cells. In this trial, the scaffold is used to hold the mesenchymal stem cells in place within the knee. The scaffold helps the cells stay where they are needed and provides a framework for new tissue to grow.

Microfracture is a surgical technique used to treat cartilage damage in the knee. It involves creating small holes in the bone beneath the damaged cartilage. This procedure encourages the body to produce new cartilage by allowing blood and bone marrow to flow into the area. In this trial, microfracture is used in combination with the 3D scaffold and stem cells to see if it enhances the healing process.

Knee Cartilage Defect – A knee cartilage defect refers to damage or wear to the cartilage in the knee joint, which can result from injury or degenerative conditions. Cartilage is a smooth, rubbery tissue that covers the ends of bones in joints, allowing for smooth movement and acting as a cushion. When this cartilage is damaged, it can lead to pain, swelling, and reduced mobility in the knee. Over time, the defect 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 may require interventions to manage symptoms and improve joint function.

Trial ID:

2023-503486-32-00

Protocol code:

OA-orMSCp-01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of Lenzumestrocel for Treating Knee Cartilage Defects in Patients

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