In short
This article provides information about ongoing clinical trials studying new treatments for cartilage injury. Currently, there is 1 clinical trial examining innovative approaches to repair damaged knee cartilage using stem cell therapy combined with surgical techniques. This trial is being conducted in Czechia and focuses on using a patient's own bone marrow stem cells to promote healing of cartilage defects in the knee joint.
Clinical trial locations
Study on the Effectiveness of Lenzumestrocel for Treating Knee Cartilage Defects in Patients
This clinical trial is investigating an innovative approach to treating knee cartilage defects using a combination of stem cell therapy and surgical techniques. The treatment being tested is called lenzumestrocel, also known as BiCure ortho MSCp, which involves using special cells derived from a patient's own bone marrow to help repair damaged cartilage in the knee.
Main inclusion criteria:
- Adults aged 18 to 55 years
- Confirmed diagnosis of a cartilage defect in the knee joint
- The defect must be located in the weight-bearing part of the thigh bone that forms the knee joint
- The damaged area should not be larger than 6 square centimeters
- Knee condition should not be more severe than stage II knee osteoarthrosis
- No previous knee surgery for cartilage defects
- Adequate hemoglobin levels (at least 110 grams per liter) and platelet count (higher than 150,000 per milliliter) before surgery
- Women who are sexually active must use highly effective birth control throughout the study
Main exclusion criteria:
- History of severe allergies or allergic reactions to medical treatments
- Active infections in the knee area
- History of cancer in the last five years
- Pregnancy or breastfeeding
- Autoimmune diseases (conditions where the immune system attacks the body's own tissues)
- Taking medications that suppress the immune system
- Blood clotting disorders
- Uncontrolled diabetes
- Severe heart disease
Focus and goal of the trial:
The study aims to determine whether combining a surgical procedure called microfracture (which creates small holes in the bone to stimulate healing) with stem cell therapy and a 3D scaffold is more effective than using microfracture and scaffold alone. The 3D scaffold is a supporting structure that helps hold the stem cells in place and provides a framework for new tissue to grow.
Participants will undergo knee surgery and be monitored over a 24-month period. Regular check-ups will assess knee function and pain levels at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. Imaging tests including MRI and X-rays will be performed at 12 and 24 months to observe the healing process. Researchers will evaluate improvements in knee function using specific scoring systems and will monitor for any side effects or adverse events throughout the study.
Investigational treatments being tested:
- Autologous bone marrow-derived mesenchymal stem cells: Special cells taken from the patient's own bone marrow that have the ability to develop into different types of cells, including those that can help repair damaged cartilage
- 3D scaffold: A supporting structure used to hold the stem cells in place within the knee and provide a framework for new tissue growth
- Microfracture: A surgical technique that creates small holes in the bone beneath damaged cartilage to encourage the body to produce new cartilage by allowing blood and bone marrow to flow into the area
Summary
Currently, there is one clinical trial available for patients with cartilage injury, specifically focusing on knee cartilage defects. This trial is being conducted in Czechia and represents an innovative approach to treating cartilage damage by combining regenerative medicine techniques with traditional surgical procedures. The study focuses on using a patient's own bone marrow stem cells, which offers the advantage of avoiding rejection since the cells come from the patient's own body.
The trial is examining whether adding stem cell therapy to conventional microfracture surgery can improve healing outcomes for patients with isolated knee cartilage defects. The 24-month follow-up period will provide valuable information about both short-term and long-term effectiveness of this treatment approach. This research is particularly relevant for adults under 55 who have sustained cartilage injuries or are experiencing early signs of wear and tear in their knee joints.
