GIOSTAR Announces FDA Clearance of the IND for Starting PHASE-2 Clinical Trial for Developing Specific Stem Cell Therapy for Type II Diabetes.
SAN DIEGO – Global Institute of Stem Cell Therapy and Research, Inc. known as GIOSTAR, a San Diego, California based Global organization at the forefront of stem cell research over two decades, developing a novel cellular therapy pipeline to improve the standard of care for treating Type II diabetes patients, today announced that the United States Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to start a Phase–2 clinical trial for DT2-SCT. The Company’s novel approach using autologous mesenchymal stem cells to alleviate the disease-caused damage in diabetics offers a new hope to address the sufferings in diabetes patients without much side-effects.
“Our innovative and noninvasive stem cell-based therapeutics may offer better treatment option for diabetic patients.”
Diabetes is not just a disease but a global health crisis. It is estimated to affect more than one billion people worldwide. The financial burden on the global healthcare system to treat diabetes is expected to reach more than one trillion dollars annually. GIOSTAR CEO, President, and Cofounder Mr. Deven Patel stated, “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.”
According to the Chairman and Cofounder of GIOSTAR, Dr. Anand Srivastava, “DT2-SCT is a cellular therapy for Type II diabetics which uses autologous stem cells, isolated from the visceral tissues of the recipients, developed to target systemic ill-effects caused by diabetes-induced pathology in patients. We are pleased to reach this milestone following extensive research and development.”
GIOSTAR expects to complete the Phase-2 clinical trial using the DT2-SCT in Type II diabetics within 12 to 18 months. GIOSTAR anticipates enrolling participants for the study at few sites across the United States.
“The diabetes is now considered as a lifestyle disease. In many cases, even lifestyle changes are not enough to eliminate the risk of developing diabetes due to certain genetic risk factors,” stated Patel. “Our innovative and noninvasive stem cell-based therapeutics may offer better treatment option for diabetic patients.”
About GIOSTAR
GIOSTAR is a global stem cell research organization committed to the discovery, development, and commercialization of stem cell based treatments to make a meaningful difference in the lives of people impacted by difficult-to-treat degenerative and other diseases. The company also aims to develop stem cell-based therapies for arthritis, long COVID complications, cancer vaccines and the fairly uncommon area of making red blood cells from stem cells. GIOSTAR red blood cell technology is ready to scale and preparing its IND for US FDA. The leadership of GIOSTAR aims to make these stem cell treatments available to the masses at affordable prices.
