Wednesday, August 31, 2016

Good Safety News in Asterias California Stem Cell Trial


Jake Javier and family -- Javier family photo
For 18-year-old Jake Javier, it's a small matter of 10 million stem cells. And hope.

Javier is one of the patients in a clinical trial backed by $14.3 million from California's stem cell agency, which announced today some good news about the safety of that research.

For Javier, however, the details about "efficacy cohorts" and "AST-OPC1were a little more personal. The former high school football player is paralyzed from the chest down as the result of a swimming pool accident in June on the eve of his high school graduation.

Today he is one of a handful of patients enrolled in the spinal cord clinical trial by Asterias Biotherapeutics of Menlo Park, Ca., which picked up the human embryonic stem cell trial after it was abandoned by Geron in 2011.

The $3 billion stem cell agency announced today that Asterias "has cleared two key safety hurdles and been given approval to expand the therapy to a larger group of patients with a much higher dose of cells."

The next step is to insert 20 million stem cells into patients, up from the 10 million that Javier received.

Javier, who played football at San Ramon Valley High School, has been the subject of widespread media attention and fund-raising, including considerable reporting by San Francisco Bay Area television station KTVU.

Writing today on the stem cell agency's blog, The Stem Cellar, Kevin McCormack, senior director for communications, said,
"For people like Jake Javier this news is not about numbers or data, it’s personal. Earlier this summer Jake broke his neck at a pool party, celebrating graduating from high school. It left him paralyzed from the chest down with extremely limited use of his arms and hands. On July 7th Jake was enrolled in the Asterias trial, and had ten million cells transplanted into his neck.
"It could be months, even as much as one year, before we know if those cells are having any beneficial effect on Jake. But at least for now we know they don’t seem to be having any negative effects."
McCormack wrote,
“Our focus is always on the patient, so making sure a potential therapy is safe is an important first step,” says C. Randal Mills, Ph.D., the President and CEO of CIRM. “I recently met with Jake Javier, a young man who was treated in this trial, and heard first-hand what he and his family are going through in the aftermath of his injury. But I also saw a young man with remarkable courage and determination. It is because of Jake, and the others who volunteer to take part in clinical trials, that progress is possible. They are true heroes.”
For more on Javier and the research see: Facebook and the stem cell agency progress report.
Left to right, Dr. Marco Lee, a member of the transplant team, Jake Javier,
 his mother, Isabelle, and Randy Mills, president of the California Institute for
Regenerative Medicine, as the stem cell agency is formally known. 

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