Chondropathy – Trials in Disease

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Ongoing Clinical Trials for Chondropathy

Currently, there are 3 ongoing clinical trials testing new treatments for chondropathy, a condition involving damage to knee cartilage. These studies are being conducted in Czechia, Germany, and the Netherlands, and they are testing innovative cell-based therapies aimed at repairing damaged cartilage and improving knee function.

Clinical trial locations

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

This trial is being conducted in Czechia and focuses on testing a treatment called lenzumestrocel, which uses stem cells taken from a patient’s own bone marrow to repair damaged knee cartilage.

Main inclusion criteria: Adults aged 18 to 55 years who have a confirmed diagnosis of cartilage damage in the knee can participate. The damage should be in a specific area of the knee called the femoral condyle and should not be larger than 6 square centimeters. Participants must be scheduled for knee surgery that involves a procedure called microfracture combined with a 3D scaffold. They should not have had previous surgery to treat cartilage defects in the knee. Before surgery, participants need to have adequate levels of hemoglobin (at least 110 grams per liter) and platelets (more than 150,000 per milliliter). Female participants who are sexually active must use effective birth control throughout the study.

Main exclusion criteria: People who cannot participate include those with a history of severe allergies, previous knee surgery on the study knee, active infections in the knee area, cancer in the last five years, or autoimmune diseases. Pregnant or breastfeeding women are also excluded, as are individuals taking medications that suppress the immune system, those with blood clotting disorders, uncontrolled diabetes, or severe heart disease.

Study focus: The trial aims to determine whether combining microfracture surgery with lenzumestrocel and a 3D scaffold is more effective than using microfracture and scaffold alone. Participants will be monitored for up to 24 months after surgery, with regular assessments of knee function, pain levels, and healing progress through imaging tests like MRI and X-rays.

Investigational treatment: The study uses autologous bone marrow-derived mesenchymal stem cells, which are special cells taken from a patient’s own bone marrow and applied to a 3D scaffold during surgery. This combination is used alongside a surgical technique called microfracture, which creates small holes in the bone to encourage healing.

Study of BP CC 001 stem cells from umbilical cord tissue for treating knee cartilage damage

This trial is taking place in Germany and evaluates a new treatment called BP CC 001, which uses mesenchymal stem cells derived from umbilical cord tissue to repair damaged knee cartilage.

Main inclusion criteria: Adults between 18 and 60 years old with symptomatic knee cartilage damage can join this study. The damaged area must be between 2 and 6 square centimeters in size and located on specific parts of the knee, including the femoral condyles, patella, or trochlea. Participants must have mild to moderate arthritis in both knees. When not taking pain medication for 24 hours, the knee pain score in the affected knee must be 70 or less out of 100, while the opposite knee must score greater than 80 out of 100. Participants must have a body mass index below 35 and provide written informed consent.

Main exclusion criteria: Individuals who cannot participate include those under 18 or over 50 years old, pregnant or breastfeeding women, and people who have had knee surgery within the last 6 months. Other exclusions include active joint infections, severe osteoarthritis, autoimmune diseases, current or recent cancer, severe obesity (BMI above 35), uncontrolled diabetes, blood disorders, active infections, allergies to collagen, participation in other clinical trials within the last 30 days, severe knee deformity, and inflammatory joint diseases like rheumatoid arthritis.

Study focus: The study aims to evaluate the safety and effectiveness of BP CC 001 in repairing damaged knee cartilage. Participants will be monitored for 24 months after surgery, with regular assessments of knee pain, function, and quality of life. Medical imaging will be used to evaluate cartilage healing.

Investigational treatment: The trial uses BP CC 001, which contains mesenchymal stem cells from umbilical cord tissue suspended in a culture solution. These cells are placed on a collagen membrane called Chondro-Gide, which acts as a support structure to help the cells stay in the damaged area during the healing process.

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

This trial is being conducted in the Netherlands and investigates a treatment called IMPACT, which combines a patient’s own cartilage cells with mesenchymal stem cells to repair knee cartilage damage.

Main inclusion criteria: Adults aged 18 to 45 years with symptomatic cartilage damage in the knee can participate. The cartilage damage must be classified as Modified Outerbridge Grade III or IV, with a size between 2 and 8 square centimeters after any necessary cleaning or smoothing. Participants must have at least 50% of their meniscus remaining, and the main ligaments in their knee must be stable. They must be able to provide written informed consent and attend follow-up visits.

Main exclusion criteria: People who cannot join include those outside the specified age range, members of vulnerable populations, and individuals unable to follow study procedures or attend follow-up visits. Other exclusions include having other medical conditions that might interfere with the study, current participation in another clinical trial, recent knee surgery or plans for surgery during the study period, pregnancy or plans to become pregnant, and allergies to the study treatment or its components.

Study focus: The trial compares the effectiveness of the IMPACT treatment with standard care, which may include physical therapy and pain medication but not surgery. Participants will be randomly assigned to receive either IMPACT or standard care and will be followed for 9 months to assess improvements in knee function and quality of life. MRI scans at 6 and 18 months will evaluate how well the knee structure repairs itself.

Investigational treatment: The study uses the Instant MSC Product, which combines a patient’s own cartilage cells (autologous chondrocytes) with mesenchymal stem cells called remestemcel. This combination is formed into a paste and injected directly into the damaged area of the knee. The control group receives standard care including pain medication and optional physical therapy.

Summary

All three ongoing clinical trials for chondropathy focus on innovative cell-based therapies to repair damaged knee cartilage. Each trial is being conducted in a different European country: Czechia, Germany, and the Netherlands. The studies test different approaches to cartilage repair, including stem cells from bone marrow, umbilical cord tissue, and a patient’s own cartilage cells. These trials represent advances in regenerative medicine, aiming to help patients with knee cartilage damage improve their knee function and quality of life. The studies involve careful monitoring over extended periods, ranging from 9 months to 24 months, to assess both safety and effectiveness of these new treatments.

Ongoing Clinical Trials on Chondropathy

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

    Not recruiting

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    Investigated diseases:
    The Netherlands