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"Completing enrollment and dosing of the first cohort of AIS-B patients marks another important milestone for our AST-OPC1 program," said Dr.
The SCiStar study has now completed enrollment and dosing in three of the five planned cohorts. The first completed cohort included three AIS-A patients who were administered a low dose of 2 million AST-OPC1 cells for the purpose of evaluating the safety of administering AST-OPC1 in the cervical spinal cord. The second completed cohort (Cohort 2) included six AIS-A patients who were administered 10 million AST-OPC1 cells, which is the first cohort dosed within the predicted efficacy dose range of 10 million to 20 million cells. In
The company is currently enrolling AIS-A patients dosed with the highest dose of 20 million cells, and the study's final cohort of AIS-B patients receiving 20 million AST-OPC1 cells is planned to begin enrollment later this quarter. The company intends to complete enrollment of the entire SCiStar study later this year, with multiple safety and efficacy readouts anticipated during 2017 and 2018.
About the SCiStar Trial
The SCiStar trial is an open-label, single-arm trial testing three sequential escalating doses of AST-OPC1 administered at up to 20 million AST-OPC1 cells in as many as 35 patients with subacute, C-4 to C-7, motor complete (AIS-A or AIS-B) cervical SCI. These individuals have essentially lost all movement below their injury site and experience severe paralysis of the upper and lower limbs. AIS-A patients have lost all motor and sensory function below their injury site, while AIS-B patients have lost all motor function but may have retained some minimal sensory function below their injury site. AST-OPC1 is being administered 21 to 42 days post-injury. Patients will be followed by neurological exams and imaging procedures to assess the safety and activity of the product.
The study is being conducted at six centers in the U.S. and the company plans to increase this to up to 12 sites to accommodate the expanded patient enrollment. Clinical sites involved in the study include the
Asterias has received a Strategic Partnerships Award grant from the
AST-OPC1, an oligodendrocyte progenitor population derived from human embryonic stem cells originally isolated in 1998, has been shown in animals and in vitro to have three potentially reparative functions that address the complex pathologies observed at the injury site of a spinal cord injury. These activities of AST-OPC1 include production of neurotrophic factors, stimulation of vascularization, and induction of remyelination of denuded axons, all of which are critical for survival, regrowth and conduction of nerve impulses through axons at the injury site. In preclinical animal testing, AST-OPC1 administration led to remyelination of axons, improved hindlimb and forelimb locomotor function, dramatic reductions in injury-related cavitation and significant preservation of myelinated axons traversing the injury site.
In a previous Phase 1 clinical trial, five patients with neurologically complete, thoracic spinal cord injury were administered two million AST-OPC1 cells at the spinal cord injury site 7-14 days post-injury. Based on the results of this study, Asterias received clearance from
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