Lineage Cell Therapeutics, a clinical-stage biotechnology company focused on developing allogeneic cell therapies for neurological conditions, has initiated the DOSED clinical trial of its Manual Inject Parenchymal Spinal Delivery System (MI PSD System).
DOSED expands to Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device.
The study aims to evaluate the safety and operational feasibility of the MI PSD System, a newly developed medical device designed to deliver OPC1 directly to spinal cord injury (SCI) sites.
OPC1 is an investigational allogeneic stem cell-derived therapy composed of oligodendrocyte progenitor cells (OPCs) and related glial cells. The treatment is designed to address cellular damage caused by traumatic spinal cord injuries by replacing or supporting dysfunctional cells in the affected area.
The DOSED study will focus on the device’s safety profile when used to administer OPC1, with secondary assessments related to neurological function following treatment.
Lineage Cell Therapeutics CEO Brian Culley said: “The DOSED study, the third clinical study of OPC1, will evaluate MI PSD, a novel delivery system designed through an external collaboration, to deliver our proprietary cells over several minutes without the need for stopping patient ventilation.
“The delivery system also is compatible with a forthcoming immediate-use formulation of OPC1 which we developed for this programme, and which eliminates the dose preparation steps conducted in prior studies.
“This study will be the first time OPC1 is administered to patients with a chronic spinal cord injury, which will be a significant milestone, as it represents an additional and larger potential patient population for this experimental therapy.”
The trial will enrol patients with both subacute SCIs (occurring between 21 to 42 days post-injury) and chronic SCIs (ranging from 1 to 5 years after injury). Participants will include individuals with complete (ASIA Impairment Scale A) or incomplete (ASIA Impairment Scale B) traumatic injuries affecting either the cervical (C4–C7) or thoracic (T1–T10) spinal regions.
As an open-label, multi-centre study, DOSED will involve 3–5 subacute and 3–5 chronic SCI patients.
The primary endpoint will assess the frequency and severity of adverse events (AEs) related to the MI PSD System or the injection procedure within the first 30 days post-treatment.
Secondary endpoints will measure AEs up to 90 days following OPC1 injection and the administration of any concomitant immunosuppressive therapies. Exploratory endpoints will examine changes in neurological function, motor and sensory scores, pain levels, and patient-reported outcomes at 30, 90, and 365 days post-treatment.
OPC1 has undergone previous clinical evaluation in two separate trials. The first was a Phase 1 safety study involving five patients with acute thoracic SCI, all of whom have been monitored for over 13 years.
The second was a Phase 1/2a dose-escalation trial with 25 subacute cervical SCI patients, with follow-up extending beyond seven years. Long-term safety data from both studies indicate no unexpected serious adverse events attributed to OPC1.
Currently, there are no US Food and Drug Administration (FDA)-approved therapies specifically targeting SCI. OPC1 has received regenerative medicine advanced therapy (RMAT) and orphan drug designations from the FDA.
