Cleft lip and palate are among the most common congenital birth defects. Today, the majority of infants with cleft lip and palate are diagnosed during routine ultrasound examination around 24 weeks of gestation.
There are numerous surgical approaches to the repair of a cleft defect, depending upon the type of cleft and other health problems. If the cleft extends into the alveolar ridge that provides structural support for the mid-face and holds the sockets of teeth, then it is necessary to fill the cleft with a bone graft. Traditionally, surgeons have repaired alveolar cleft palates with a bone graft from the iliac crest of the pelvis. This approach subjects the child to an additional surgical procedure with associated discomfort and risks.
The group at the University of Texas, has developed an approach that uses the supportive tissue of the umbilical cord as a bone graft to augment the repair of alveolar cleft palates. The umbilical cord is a fibrous structure filled with gelatinous tissue that contains mesenchymal stem/stromal cells that support bone growth and can develop into osteoblasts. This supporting tissue of the umbilical cord is called Wharton’s jelly. Even when minced, the collagen fibres in the cord tissue give it structural characteristics that enable it to pack the gap that must be bridged in alveolar cleft palate repair.
As opposed to processing techniques that isolate the stem cells within the umbilical cord via enzymatic digestion of the collagen matrix, they specifically try to preserve the structure of the collagen matrix that is rich in glycosaminoglycan and hyaluronic acid. They have developed unique devices that selectively remove the umbilical blood vessels and the amnion lining so that the Wharton’s jelly is isolated. The goal was to isolate a tissue product that contains only mesenchymal stem/stromal cells and not epithelial stem cells that are found in the lining of the blood vessels or the outer lining of the umbilical cord.
A typical surgery for alveolar cleft palate repair only requires 15-20 gm of Wharton’s jelly, which can be obtained from a single umbilical cord. They have performed multiple pre-clinical studies that demonstrate that this approach improves healing of cleft palate defects in animals. These are being repeated in larger animals as required by the FDA prior to translating this approach to treat children with cleft lip and palate. Once these final components are completed, they anticipate that clinical trials should begin within the next 12-18 months.
At Next Biosciences, Wharton’s jelly is minced and cryopreserved. The tissue will be able to be used in surgical procedures as mentioned above. Mesenchymal stem cells will also be able to be isolated for alternative uses if needed.