In short
Spheroids of human autologous matrix-associated chondrocytes are a cell-based medicine used to repair cartilage defects in the knee. The medicine is authorised in the European Union under the name Spherox for symptomatic defects no larger than 10 cm² in adults and adolescents whose bones have finished growing. A Phase 3 trial is comparing the authorised product against a minced cartilage procedure in 166 participants with full-thickness cartilage defects of the knee.
Key points
- Spherox is an authorised medicine in the EU for repairing knee cartilage defects up to 10 cm².
- It contains spheroids of the patient's own cartilage cells (chondrocytes) grown in a laboratory.
- The medicine is given as a suspension implanted into the knee during arthroscopy (keyhole surgery).
- A Phase 3 trial is comparing Spherox with minced cartilage implantation in 166 participants.
- The main measure in the trial is the KOOS5 score at 24 months after randomisation.
- The trial is currently authorised but not yet recruiting.
What is spheroids of human autologous matrix-associated chondrocytes?
Spheroids of human autologous matrix-associated chondrocytes are a cell-based medicine used to repair defects in the cartilage of the knee. The medicine is authorised for use in the European Union under the trade name Spherox. It contains spheroids — spherical aggregates — of chondrocytes, which are cells found in healthy cartilage. The cells are prepared from the patient's own tissues, making this an autologous (self-donated) therapy.
How does it work?
Chondrocytes are the cells that produce and maintain cartilage. In this medicine, a small sample of the patient's own cartilage is taken by arthroscopy, and the cartilage cells are grown in the laboratory to prepare a suspension of chondrocyte spheroids. When the suspension is placed into the damaged area of the knee cartilage, the chondrocyte spheroids attach to the cartilage within 20 minutes and are intended to form new cartilage tissue.
Which conditions is it used or studied for?
- Symptomatic cartilage defects of the knee — Spherox is authorised to repair defects in the knee cartilage in patients who experience symptoms such as pain and problems moving the knee, where the affected area is no larger than 10 cm².
- Full-thickness cartilage defects of the knee — a Phase 3 trial is studying the medicine in this condition, comparing it with autologous minced cartilage implantation.
How is it given?
Spherox is available as a suspension for implantation into the knee joint. The medicine is prepared specifically for each individual patient and must be given by a qualified doctor in a medical facility. It is placed into the damaged area of the patient's cartilage during an arthroscopy, a type of keyhole surgery. In the Phase 3 trial, the medicine is administered as 10–70 spheroids per cm² as an implantation suspension.
What do the clinical trials show?
One Phase 3 trial is registered for spheroids of human autologous matrix-associated chondrocytes in the EU Clinical Trials Information System. The trial, called MinCaRCT, is a non-inferiority study comparing surgical treatment of cartilage defects of the knee with autologous minced cartilage implantation (AMCI) against matrix-associated autologous chondrocyte implantation (M ACI) using Spherox.
The primary efficacy endpoint is the KOOS5 score — a composite Knee injury and Osteoarthritis Outcome Score — at 24 months after randomisation. This measures knee-related symptoms, function and quality of life.
The trial plans to enrol 166 participants and is currently authorised but not yet recruiting.
What side effects are known?
The European Medicines Agency product information for Spherox lists side effects, but the provided source material for this page does not include a detailed side-effect profile. Patients receiving the medicine should follow a specific rehabilitation programme, including physiotherapy, after treatment.