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Cells proliferating inside and surrounding the porous polymeric microsphere |
The CSIR has developed a novel injectable suspension to expand tissue and induce tissue regeneration. This suspension has potential application in several areas of soft tissue augmentation, with the first targeted application being gastroesophageal reflux disease (GERD).
GERD affects roughly 15% and 3% of the total US and South Africa populations, respectively. Apart from the discomfort caused by the symptoms, GERD may lead to an increased risk of oesophageal cancer. GERD is caused by chronic inflammation of the sphincter muscle, which results in a state of permanent relaxation of the smooth muscle. This allows gastric fluids to enter the oesophagus and cause chronic heartburn. Many GERD sufferers have to take expensive medication for the rest of their lives. The main alternative to medication is surgery (laparoscopic fundoplication). Apart from the surgery being very invasive, studies have found that more than 62% of patients who undergo surgery return to medication within 10 years of surgery.
A newly emerging technology is endoscopic treatment of GERD, which is administered through the gastrointestinal tract. The objective of this project is to develop an endoscopic treatment for GERD to achieve both short and long-term bulking effects in the lower oesophageal sphincter (LES) muscle, and to provide a permanent solution to the condition through a minimally-invasive endoscopic treatment.
"We have developed an injectable suspension of biocompatible, resorbable polycaprolactone (PCL) porous microspheres for injection into the LES muscle using an endoscopic needle," says one of the inventors, Kersch Naidoo. A patent is currently pending.
The microspheres will act as tissue expanders (i.e. providing a bulking effect) in the short term, with the induction of tissue regeneration in the long term. Tissue regeneration is stimulated through the optional incorporation of growth factor-containing media such as platelet-rich plasma (PRP) in the microsphere suspensions and through the morphology of the spheres themselves. Inclusion of autologous stem cells or the differentiated products of these, could allow for additional permanent bulking and restored muscle function, while the resorbable PCL will provide a harbour for cell growth.
Naidoo adds that in vitro tests have shown cells attaching to the particles and preferential localisation inside the shell. In vivo biotoxicity tests have shown no significant biotoxicity. The technology is now proceeding to an initial in vivo efficacy trial.
Enquiries: CSIR Communications
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