SanBio has received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to conduct a Phase 2 clinical trial for using allogeneic stem cells to treat chronic traumatic brain injuries.
The company submitted its clinical trial notification of the regenerative cell therapy (SB623) for traumatic brain injury to PMDA last month.
Claimed to be the first of its kind, the stem cell therapy for traumatic brain injury (STEMTRA) trial will study the safety and efficacy of SB623 cell therapy in treating patients with chronic motor impairments following a traumatic brain injury.
Enrolment for the trial started in the US in October last year, with plans to include clinical trial sites and 52 patients in Japan in order to speed-up the overall enrolment process.
SanBio research head Damien Bates said: "SanBio’s regenerative cell medicine, SB623, has improved outcomes in patients with persistent motor deficits due to ischemic stroke, and our preclinical data suggest it may also help TBI patients."
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SB623 cells are modified allogeneic mesenchymal stem cells, derived from bone marrow stromal cells isolated from healthy adult donors. When administered into neural tissue, they support recovery from injury by triggering the brain’s natural regenerative ability.
SanBio recently completed a US-based Phase 1/2a clinical trial for SB623 in patients with chronic motor impairments six months to five years following an ischemic stroke, with results suggesting the medicine’s potential to improve motor function following a stroke.
Based on these results, a Phase 2b randomised double blind clinical trial of 156 subjects began enrolment in December last year.
The company also noted that traumatic brain injuries can result from several causes, such as car crashes, falls, occupational hazards and sports injuries that can lead to lifelong motor deficits. There are currently no approved medicines available for the treatment of persistent motor disability from traumatic brain injury.
Japan had granted marketing approval for regenerative medicines following an amendment to the Pharmaceutical Affairs Law in 2014.
SanBio expects to begin the proposed trial in this year with funds from Mizuho Bank and from a stock listing in April last year.