A new technology developed in Belgium couples cartilage-forming human cells and resorbable polymers to repair cartilage damage in knees.
TiGenix says that 130,000 people in Europe and the United States could benefit from the emerging regenerative technology, possibly avoiding painful and costly knee replacements.
Cells called chondrocytes are taken from a healthy region of the patient's cartilage, grown outside the body, and then re-implanted in a surgical procedure in a product developed by TiGenix called ChondroCelect.
The cells are packaged in resorbable natural polymers that disappear after the new tissue begins growing. Typically used resorbable polymers are polycaprolactone (PCL), polylactide (PLA) and polyglycolide (PGA).
Janet Cuy, who worked on engineered biomaterials at the University of Washington as a research scientist, says that natural polymers, such as collagen, are of great interest in tissue-engineering because they are:
- Non-toxic and non-inflammatory,
- Mechanically similar to the tissue being replaced,
- Highly porous,
- Encourage cell attachment and growth,
- Easy and cheap to manufacture, and
- Capable of attachment with other molecules (to potentially increase scaffold interaction with normal tissue).
Collagens constitute 25 percent of the total protein mass in mammals. Collagen molecules polymerize to form fibers of varying length, thickness, and interweaving pattern. The predominant form used in biomaterial applications is a "rope-forming" collagen that can be found almost everywhere in the body, including skin and bone.
CondroCelect was commercially launched in Europe earlier this year. The U.S. Food and Drug Administration requested a new study before the filing of a Biologics License Application (BLA) for ChondroCelect, and invited TiGenix to seek Special Protocol Assessment.
Due to the delay and additional investment associated with the additional trial, TiGenix is pursuing corporate partnering opportunities and other strategic options for the further development of ChondroCelect in the U.S. Meanwhile the company's U.S. development activities have been put on hold and a Memphis, TN manufacturing facility has been closed.