Growing our own Cardiac Vessels
Most doctors use plastic grafts to replace damaged arteries and blood vessels in children’s hearts. The problem is that organic hearts grow over time and synthetic plastics do not. To solve this, Dr. Christopher Breuer and Dr. Toshiharu Shinoka developed the Tissue-Engineered Vascular Graft (TEVG). In this method, they insert cells from the patient’s bone marrow on a biodegradable scaffold and implant the seeded scaffold in the child. In six months, the scaffolding has disappeared and the vessel resembles an artery or vein that will grow along with the patient. By using organic material from the child’s own body, Nationwide Children's surgeons can avoid the problems associated with synthetic grafts and implantations.
The TEVG is currently regulated as a combination product under an Investigational Device Exemption (IDE), which was approved in August, 2019. DDDS supported the filing and regulatory strategy of the TEVG to help bring this truly novel treatment to patients.
Childhood Cancer – Groundbreaking Technology and Treatment
Due to considerable advances in research and medical technologies, the national 5-year survival rate for children with cancer has increased from 58% in 1975 to nearly 80% today. More, however, can and must be done to change outcomes for children affected by this disease.
Cellular therapy to fight cancer has made tremendous breakthroughs in recent years. Using the body’s own immune system, this technology specifically combats cancer cells while leaving healthy cells untouched. Specialized genetic techniques give instructions to cells that are failing to remove the cancer. By both “kick starting” the natural immune system and flagging the cancer cells that normally evade the body’s detection, cellular therapy holds the promise of safe, effective treatment without the side effects that usually accompany cancer medication.