Cleft palate is among the most common of all birth defects and affects about one in 1,500 births each year in the U.S. alone, resulting in physical, medical, social, emotional, and developmental problems in affected children in addition to the high health care costs. Current treatment requires an initial surgical closure of the cleft, orthodontic dental care, speech therapy, bone grafting, and multiple surgeries over the course of 18 years. Thus, there is a pressing need to develop new and effective methods for treatment to provide young patients with a safer and more efficient option that will result in a complete and permanent closure of the palatal cleft shortly after birth. This application focuses on developing a new and innovative bone product which can be customized to meet the needs of individual patients. This product utilizes a novel scaffold that supports efficient bone regeneration using the patient’s own stem and progenitor cells. Cleft palate can be detected prenatally by ultrasound and confirmed by a physical examination after birth allowing the collection of the necessary stem and progenitor cells for the customized product. If successful, this approach will eliminate the need for multiple surgeries and correct the problem early in life providing a substantial benefit to infants and children.
Cleft palate is the most common birth defect (1 in 1,500) and has an extensive socioeconomic impact on the State of California. Most children born with clefts require ongoing care that generally involves multiple surgeries and frequent visits to health care professionals. A recent study by the Centers for Disease Control and Prevention has shown that the average expenditure for an infant with cleft palate is approximately $100,000. Another study by ReSurge International estimated the lifetime economic impact of cleft palate repair to be between $152,372 and $375,412 per affected individual. In consideration of the socioeconomic burden/impact imposed upon the State of California, the technology proposed could dramatically reduce millions of dollars in direct and indirect medical costs. In addition to the overall economic benefit, the intent is to provide the technology to all patients including those through special needs programs geared towards reducing the costs to the patient and the State of California once this product is commercialized. The State of California will also generate revenue from license fees and royalties from worldwide sales of the scaffold which is the basic building block of the proposed product. If successful, this technology will result in the development of other stem cell-based orofacial and orthopedic treatments in California and subsequent revenue generation.