Lineage Cell Therapeutics’ Spinal Cord Injury Stem Cell Trial, New Delivery Device

The new DOSED trial will explore a novel delivery method for OPC1 cells, potentially bringing hope to chronic SCI patients.

Neurology

May 13, 2025

(In February) Lineage Cell Therapeutics initiated a clinical trial using a stem cell-derived cell transplant for spinal cord injury.

They’re calling the trial DOSED: (Delivery of Oligodendrocyte Progenitor Cells (OPCs) for Spinal Cord Injury: Evaluation of a Novel Device)

The DOSED trial will examine the safety and efficacy of the Manual Inject Parenchymal Spinal Delivery System (MI PSD System), a new device designed to deliver OPC1 directly into the spinal cord injury (SCI) site.

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OPC1 is an investigational, allogeneic (donor-derived) cell transplant containing oligodendrocyte progenitor and glial cells. These cells are intended to replace or support the spinal cord cells damaged or lost due to traumatic injury, potentially restoring or improving functional activity.

OPC1 has been tested in two clinical trials so far; a five patient Phase 1 study in acute thoracic spinal cord injury, where all subjects were followed for at least 10 years, and a 25 patient Phase 1/2a study in subacute cervical spinal cord injury, where all subjects were evaluated for at least 2 years.

Dr. Sanjay Gupta from CNN covered a young man who was given this therapy, which reportedly showed some promise:
https://www.cnn.com/2025/01/24/health/video/stem-cell-hand-gupta-reeve-digvid?cid=external-feeds_iluminar_google

The DOSED clinical study will enroll both subacute SCI patients (between 21 to 42 days post-injury) and chronic SCI patients (between 1 to 5 years post-injury).

The OPC1 clinical development program was one of the first cell therapy trials supported by the California Institute for Regenerative Medicine (CIRM) under Proposition 71.

Lineage also co-founded and continues to co-sponsor the Annual Spinal Cord Injury Investor Symposium in partnership with The Christopher & Dana Reeve Foundation, aimed at increasing awareness, supporting clinical trial participation, and improving the likelihood of successful product development for SCI therapies.

Participants at past symposiums have included AbbVie, Mitsubishi Tanabe, Neuralink, NervGen Pharma, and ONWARD.

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