BIOLOGICAL MYOBLAST TREATMENT FOR GASTROESOPHAGEAL REFLUX DISEASE ( GERD ). BOLANDCELL 2007 HORIZONS AND BEYOND.
GERD is a very common clinical problem affecting adults , babies and children. BOLANDCELL has clinical experience in this field. But its research is focused on the development of new technologies. Every second counts in this research field and the race is on for the development of new biological treatment modalities. GERD is a world wide problem and gastroenterologists and surgeons have been grappling with the sequelae thereof for decades. Will it be pills , surgery or both? GERD is associated with definable morbidity and mortality. This is evidence-based. Barrett's esophagus is associated with a small, but definitive incidence of esophageal carcinoma, following unchecked acid-reflux. In some persons with structural damage to the esophaus following long-standing acid-reflux, it is an incurable condition. Pills, including chronic PPI ingestion, also have side-effects. Palliation with dietary measures, pills or surgery is helpful in these unfortunate persons. Surgeons and the pharmacological industry have a vested interest in GERD. Much of it is financially and profit driven. Also, patients want to get rid of heartburn. But is switching off acid with pills and surgical plication the only answer ? This is an important research question. What about the biological approach, that is being developed on the bench in the lab right now? What about the new technological developments in the application of cell therapy for GERD? It may be theoretical, need testing in man, but this technology is going to impact heavily on the way we view GERD in the future. Cell therapy is going to radically affect us all, in the not too distant future. But not all treating parties have access to cell therapy technology and biology.
Histology textbooks show the skeletal and smooth muscle component of the esophagus. " At the distal end of the esophagus, the muscular layer consists of only smooth muscle cells; in the mid portion, a mixture of striated and smooth muscle cells; and at the proximal end, only striated muscle cells are present: Junqueira 10 th edition,2003". If cell therapy is to be considered, the lower third of the esophagus and gastro-esophageal junction landmarks are important. Cultured autologous myoblasts would probably be the cell line of choice. A skeletal muscle biopsy is taken 4 weeks before the procedure. The thigh muscles are the best site for the donor muscle cells. The cells are proliferated by special technology ex-vivo using special technology in a GMP lab. The cells are concentrated and eventually released for injection after a period of about 3-4 weeks. The correct patient with GERD is selected and the cells are injected endoscopically via the lumen at one sitting into the region of the LES. With time the cells engraft and proliferate to form a thichened muscular wall. If correctly done, the new spincter wall and thickening will prevent or reduce the acid-reflux. Outcome can be determined by standard PH studies and application of a 24-48 slice CT scanner to assess thickening. So the patients own skeletal myoblasts or satellite cells are implanted at the lower end of the esophagus, by minimally invasive endoluminal technology. While the cells are engrafting, the patient can be temporarily managed with a PPI which can be stopped at a later stage. This procedure appears completetly feasible and will be far easier to perform than when injecting autologous cultured myoblasts into the myocardium of persons with irreversible ischemic heart disease and heart failure. This will certainly become revolutionary biological treatment for GERD. BOLANDCELL predicts that this will be the research and development focus for GERD in the future. It seems logical and the small technical issues can be overcome. Quality cells are needed however to allow growth and thickening of the new LES sphincter. The local technology for the ex-vivo proliferation and culture of skeletal myoblasts is available in Cape Town .
Endoscopic therapies offer the great potential for obviating the potential drawbacks of long-term PPI treatment and traditional antireflux surgery. Enteryx, now withdrawn for clinical use, induces peri-esophageal fibrosis after injection.
Another innovative way of treating GERD is by application of the Stretta procedure. This entails radiofrequency treatment of the gastroesophageal junction. Patient selection is however, important. These are exciting times for the biological treatment of GERD.