Friday, 6 September 2013

America Stem Cell receives FDA clearance for its multi-center trial

Αmerica Stem Cell (ASC) issued a press release today announcing that it has received clearance from the FDA to initiate its Phase I/IIa nationwide multi-center dual-umbilical cord transplantation study. Purpose of the study is to evaluate 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. Up until now 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.

Click here for more information on ASC-101

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