The stem cell clinic trial being run by Asterias Biotherapeutics for spinal cord injury (SCI) reported (via CIRM) some preliminary very good news as it is so far seems safe and will be expanded to involve more patients. In the next phase, reportedly “Asterias is now looking to enroll 5-8 patients for this 20 million cell phase.” You can also read the company’s PR on this development here.
CIRM’s report by Kevin McCormack on this advance also included a window into the personal story of a young patient, Jake Javier, who is a participant in the trial:
“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.”
Jake is some kind of hero! Here’s more info from Asterias’ PR:
“The SCiStar study is an ongoing Phase 1/2a clinical trial funded in part by a $14.3 million grant from the California Institute for Regenerative Medicine (CIRM) and is designed to evaluate the safety and efficacy of escalating doses of AST-OPC1 in newly injured patients with sensory and motor complete cervical spinal cord injury (SCI), as well as newly injured patients with sensory incomplete SCI. These patients are commonly referred to as AIS-A and AIS-B patients, respectively. The results of the ongoing trial continue to support a positive safety profile for AST-OPC1. There have been no serious or unexpected adverse events related to AST-OPC1, the administration procedure or the accompanying short course of low-dose immunosuppression in any of the patients treated with AST-OPC1, including five patients in an earlier Phase 1 trial with neurologically complete thoracic SCI.”
The hope is that as this CIRM-supported trial proceeds, there will be continuing evidence of safety as well as indications of efficacy. Way to go CIRM and Asterias.
For more on this development see David Jensen’s interesting piece over at California Stem Cell Report.