In short
Currently, there is 1 ongoing clinical trial investigating new treatments for knee cartilage defects. This trial is exploring the use of stem cell therapy combined with surgical techniques to improve cartilage repair and knee function. The trial is being conducted in Czechia and involves patients aged 18 to 55 with specific types of cartilage damage in the knee joint. (Also known as: Chondroplasty)
Clinical trial locations
Study on the Effectiveness of Lenzumestrocel for Treating Knee Cartilage Defects in Patients
This clinical trial is investigating a novel approach to treating knee cartilage defects using a combination of stem cell therapy and surgical repair techniques. The treatment being studied is called lenzumestrocel, also known as BiCure ortho MSCp, which consists of special stem cells taken from a patient's own bone marrow.
Main inclusion criteria:
- Adults aged between 18 and 55 years
- Confirmed diagnosis of cartilage damage in the knee joint
- Knee condition not more severe than stage II osteoarthrosis (moderate wear and tear)
- Cartilage defect located in the weight-bearing part of the thigh bone within the knee joint
- Isolated defect not larger than 6 square centimeters
- No previous knee surgery for cartilage repair
- Adequate blood counts: hemoglobin at least 110 grams per liter and platelet count higher than 150,000 per milliliter
- Female participants 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
- Previous surgery on the knee being studied
- Active infections in the knee area
- History of cancer in the last five years
- Pregnancy or breastfeeding
- Autoimmune diseases (conditions where the body's immune system attacks its own tissues)
- Taking medications that suppress the immune system
- Blood clotting disorders
- Uncontrolled diabetes or severe heart disease
Focus and goal of the trial:
The study aims to determine whether combining stem cell therapy with a surgical technique called microfracture and a 3D scaffold is more effective than using microfracture and scaffold alone. Microfracture is a procedure that involves creating small holes in the bone beneath damaged cartilage to stimulate natural healing. The 3D scaffold is a structure that supports the growth of new tissue and holds the stem cells in place.
Participants will undergo surgery to treat their knee cartilage damage and will 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 X-rays and MRI scans will be performed at 12 and 24 months to observe the healing process and tissue regeneration.
Investigational treatments being tested:
- Autologous bone marrow-derived mesenchymal stem cells: Special cells taken from the patient's own bone marrow that can develop into different types of cells, including those that help repair damaged cartilage
- 3D scaffold: A supporting structure that holds the stem cells in place and provides a framework for new tissue growth
- Microfracture technique: A surgical procedure that creates small holes in the bone to encourage natural cartilage regeneration by allowing blood and bone marrow to flow into the damaged area
This regenerative medicine approach focuses on repairing and restoring damaged knee cartilage by promoting the body's natural healing processes at the tissue level.
Summary
Currently, there is one ongoing clinical trial investigating innovative treatments for knee cartilage defects. The trial is being conducted in Czechia and focuses on regenerative medicine approaches using stem cell therapy combined with established surgical techniques. The study is exploring whether adding a patient's own bone marrow-derived stem cells to conventional microfracture surgery can improve outcomes for people with isolated cartilage damage in the knee joint. The trial includes a comprehensive follow-up period of 24 months with multiple assessment points to evaluate both short-term and long-term effectiveness and safety of this treatment combination.
