StemCells Inc. has a history not much different from those of dozens, even hundreds, of biotech companies all around California. Co-founded by an eminent Stanford research scientist, the Newark, Calif., firm has struggled financially while trying to push its stem cell products through the research-and-development pipeline. It collects about $1 million a year from licensing patents and selling cell cultures but spends well more than $20 million annually on R&D, so it runs deeply in the red. On the plus side, StemCells Inc. has had rather a charmed relationship with the California stem cell program, that $3-billion taxpayer-backed research fund known formally as the California Institute for Regenerative Medicine. The firm ranks first among all corporate recipients of approved funding from CIRM, with some $40 million in awards approved this year. That's more than has gone to such established California nonprofit research centers as Cedars-Sinai Medical Center, the Salk Institute for Biological Studies, and the Sanford-Burnham Medical Research Institute. The record of StemCells is particularly impressive given that one of the two proposals for which the firm received a $20-million funding award, covering a possible Alzheimer's treatment, was actually rejected by CIRM's scientific review panel twice. Nevertheless, the stem cell … Continue reading →

StemCells Inc. has a history not much different from those of dozens, even hundreds, of biotech companies all around California. Co-founded by an eminent Stanford research scientist, the Newark, Calif., firm has struggled financially while trying to push its stem cell products through the research-and-development pipeline. It collects about $1 million a year from licensing patents and selling cell cultures but spends well more than $20 million annually on R&D, so it runs deeply in the red. On the plus side, StemCells Inc. has had rather a charmed relationship with the California stem cell program, that $3-billion taxpayer-backed research fund known formally as the California Institute for Regenerative Medicine. The firm ranks first among all corporate recipients of approved funding from CIRM, with some $40 million in awards approved this year. That's more than has gone to such established California nonprofit research centers as Cedars-Sinai Medical Center, the Salk Institute for Biological Studies, and the Sanford-Burnham Medical Research Institute. The record of StemCells is particularly impressive given that one of the two proposals for which the firm received a $20-million funding award, covering a possible Alzheimer's treatment, was actually rejected by CIRM's scientific review panel twice. Nevertheless, the stem cell … Continue reading →

COLLIER COUNTY - A Southwest Florida doctor spent another day in court fighting for his right to practice medicine. Bonita Springs cardiologist Zannos Grekos' license is currently suspended because two of his patients died after undergoing a controversial stem cell procedure. Wednesday was day two of what's scheduled to be a four day trial. The courtroom was again filled with patients supporting Grekos and his stem cell treatment. This hearing focuses only on the first patient that died after getting that treatment. Her family was also in attendance and wants Grekos' medical license revoked. Dr. Richard Roland spoke about a call he got from Grekos in 2010. He had just performed a stem cell procedure on his patient Domenica Fitgzerald and something went wrong. Roland was Fitzgerald's ICU doctor. "I was quite shocked. My first comment was, 'You did what?' His response was, 'Yes. We've been having good luck with these procedures,'" Dr. Roland said. "I had concerns that this was criminal." Fitzgerald's family says the breast cancer survivor was looking for a cure for nerve damage caused by chemotherapy. They say Grekos gave her false hope. See the article here: Stem cell doctor in court: Day 2 … Continue reading →

WASHINGTON, DC--(Marketwire - Oct 17, 2012) - The Alliance for Regenerative Medicine (ARM), the international organization representing the interests of the regenerative medicine community, announced the publication today of an article on FDA communications to help companies developing cell-based therapies by clarifying the development pathway. The article, entitled "Communications with the FDA on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?" will be published in the journal Stem Cells Translational Medicine. It is co-authored by representatives from ARM, Janssen R&D, GE Healthcare and Life Technologies, with the lead author from the California Institute for Regenerative Medicine (CIRM). "There are a number of ways cell-based therapy companies can communicate with FDA that will help them navigate the road from the bench to a regulatory submission," said Michael Werner, Executive Director of ARM. "We hope that our combined experience as co-authors, and our attempt to create a single source of guidance on the regulatory process, will help companies bring new cell-based therapies through clinical trials and the regulatory review process more quickly so they can reach patients faster," added Mr. Werner. Lead author Ellen Feigal, MD, Senior Vice President for Research and Development at the California Institute for … Continue reading →