NEW YORK – The US Food and Drug Administration has granted the Global Institute of Stem Cell Therapy and Research (Giostar) permission to begin a Phase II trial of DT2-SCT, an autologous stem cell therapy it is developing for type 2 diabetes.
Giostar, a stem cell research organization based in San Diego, said this week it expects to complete the clinical trial in 12 to 18 months. In the study, type 2 diabetics will receive DT2-SCT, which comprises autologous mesenchymal stem cells isolated from visceral tissues. These cells are engineered to target and treat damaged parts of the pancreas.
Giostar CEO, President, and Cofounder Deven Patel said he intends to make any stem cell treatments that garner regulatory approval available at an affordable price.
"Upon a successful completion of the clinical trials, Giostar intends to make this treatment affordable to masses and poised to capture significant global market share due to Giostar's existing global infrastructure of hospitals and research centers," Patel said in a statement.