Asterias Biotherapeutics, based in Fremont, California, announced today positive interim efficacy data in the Company's ongoing Phase 1/2a clinical study in complete cervical spinal cord injury (loss of both motor function and sensation below the neck) patients.
While early in the study, with only 4 of the 5 patients having reached 90 days after dosing, all patients who received 10 million AST-OPC1 cells have shown at least one motor level of improvement (regaining some function in their arms) while 2 of 5 patients achieved two motor levels of improvement (regaining some function in their arms, hands and fingers) on at least one side of their body. Researchers initially thought that results would take 6-12 months to see. The next phase of the study - starting this fall - will utilize an even higher dose of AST-OPC1 (20 million cells).
Oligodendrocyte Progenitor Cells (or OPC's) are a type of cell that is normally present in your brain and in your spinal cord throughout your life. These OPCs mature into a cell type called oligodendrocytes which help form the myelin (the insulation) around the nerve fibers in your brain and your spinal cord that allow nerve impulses to be conducted between your brain and spinal cord and ultimately to other parts of your body. AST-OPC1 is designed to help repair the myelin that has been damaged because of an injury to the spinal cord, and deliver additional benefits to spinal cord functioning as well. By implanting AST-OPC1 cells, the hope is that the signal from the brain that travels through the nerves of the spinal column can be restored (even partially) to allow for movement and sensation in the body.
Each year in the U.S. more than 17,000 people suffer a severe, debilitating spinal cord injury. Lifetime healthcare costs for these patients can often approach $5 million. The ability for a person to regain use of their arms, hands and fingers can dramatically improve their quality of life and ability to function independently.
The study is being conducted at six centers in the U.S.
Additional information can be found at www.clinicaltrials.gov using Identifier NCT02302157, and at the SCiStar Study Website (www.scistar-study.com).
The SCiStar study is funded in part by a $14.3 million grant from the California Institute for Regenerative Medicine (CIRM).
For more information on Asterias, please visit www.asteriasbio.com