San Antonio (Press Release) - America Stem Cell, Inc. (ASC) announced today it has received clearance from FDA for its Phase I/IIa nationwide multi-center dual-umbilical cord trans­plan­ta­tion study eval­u­ating ASC-101 in patients with hema­to­logic malig­nan­cies and myelo­dys­plastic syn­drome.

ASC-101 is cur­rently undergoing evaluation in a single-center study at The University of Texas MD Anderson Cancer. To date, 12 patients have been enrolled in the study with 9 patients evaluable. On the basis of data obtained in the single-center study, FDA has given approval to proceed with a multi-center trial.

"Enhancing umbilical cord stem cell engraftment into bone marrow in the dual cord trans­plant setting will im­prove clin­i­cal out­comes for patients with serious, life-threatening cancers and other disorders for which hematopoietic stem cell trans­plant is prescribed," said, Dr. Elizabeth Shpall, MD, Medical Director, Cell Therapy Laboratory and Director, Cord Blood Bank at M.D. Anderson Cancer Center and Study Chair on the ASC-101 Phase I/IIa clin­i­cal trial. Dr. Shpall has submitted an abstract to the upcoming American Society of Hematology (ASH) meeting in December describing the clin­i­cal results to date with ASC-101.

"There is a sig­nif­i­cant unmet medical need to im­prove stem cell engraftment into bone marrow for patients undergoing umbilical cord trans­plan­ta­tion, and America Stem Cell is committed to filling that need," said Dr. Linda Paradiso, Chief Development Officer at ASC. ASC-101 is a novel enzyme treat­ment that will poten­tially transform hematopoietic stem cell trans­plan­ta­tion by accelerating patient immune system and platelet re­cov­ery, reducing opportunistic in­fec­tions and other co-morbidities, and improving patient survival.

"ASC was founded with the vision to make stem cell trans­plants safer and more efficacious for patients undergoing cell ther­apy. The expansion of this trial using ASC-101 in cancer patients undergoing stem cell trans­plan­ta­tion is a major step forward in ad­vanc­ing the ASC clin­i­cal pipe­line," said Lynnet Koh-LeMaire, Chief Executive Officer/Founder of America Stem Cell.

America Stem Cell is com­mer­cial­iz­ing breakthrough plat­form tech­nolo­gies and prod­ucts that enable cell-based ther­a­pies and immuno­therapies across a wide range of indi­ca­tions. ASC's tech­nolo­gies target homing and engraftment of thera­peutic cells to sites of ischemia, inflammation and disease for im­proved clin­i­cal efficacy and patient out­comes. The most ad­vanced prod­uct (ASC-101), manu­fac­tured at Florida Biologix, is cur­rently in PhI/IIa clin­i­cal trials for cord blood trans­plan­ta­tion. ASC's second wave of prod­ucts will expand the plat­form tech­nology to a broad range of cell types and diseases.

About America Stem Cell, Inc.

America Stem Cell is a privately-held bio­technology com­pany based in San Antonio, TX, with offices in San Diego, CA, and is dedicated to the devel­op­ment and com­mer­cial­iza­tion of enabling tech­nolo­gies to en­hance and expand the thera­peutic poten­tial of stem cell ther­a­pies. The key tech­nology plat­forms (ASC-101 and ASC-102) are designed to im­prove the homing and engraftment of stem cells to target organs and in­­crease their thera­peutic poten­tial for patients in need of hematopoietic stem cell trans­plan­ta­tion. Additionally, these tech­nolo­gies have the poten­tial to en­hance efficacy in stem cell treat­ment of inflammation from chemo­ther­a­py/​radiation, solid tumors, auto­immune diseases, and ischemic diseases in­­clud­ing myo­cardial infarction and stroke. ASC has part­ner­ships and col­lab­o­rations with Kyowa Hakko Kirin, Spectrum Health Innovations, Florida Biologix, various medical research institutions in­­clud­ing The University of Texas M.D. Anderson Cancer Center, Oklahoma Medical Research Foundation, Fred Hutchinson Cancer Center, University of California San Diego, the Sanford-Burnham Institute, Indiana University, Juvenile Diabetes Research Foundation, as well as corporate part­ner­ships. For addi­tional in­for­ma­tion, please contact Lynnet Koh at 760-612-6277, or view www.americastemcell.com.

Source: America Stem Cell, Inc.