Frequently asked questions about the DOSED Study
About the Study, Investigational Device and Investigational Therapy
Who can participate, how long is the study, and how many visits are required?
Learn more about participant eligibility and study design and duration here.
What is the investigational device?
The MI PSD system is designed to allow for the administration of cells to the spinal cord without stopping the persons respiration during the surgical procedure to implant the cells. Elimination of the need to stop respiration during surgery is expected to reduce the complexity, risk, and variability of administering cells to the area of injury. This study will evaluate the device’s ability to safely and effectively deliver LCTOPC1, Lineage Cell Therapeutic Inc.’s oligodendrocyte progenitor cell (OPC) to the spinal cord.
More detailed information may be found at clinicaltrials.gov.
What is the investigational therapy (LCTOPC1)?
LCTOPC1 is a cell population composed, in large part, of oligodendrocyte progenitor cells (OPCs). OPCs are naturally-occurring precursors to the cells which provide electrical insulation for nerve axons, which is called a myelin sheath. SCI occurs when the spinal cord is subjected to a severe crush or contusion injury which can damage this electrical insulation, making it more difficult for nerves to conduct signals. In other words, the communication that is transmitted across the spinal cord for the body to function as intended is disrupted. This loss/disruption of communication and other factors can lead to severe functional impairment, including limb paralysis, abnormal pain signaling, and loss of bladder and sexual function. LCTOPC1 is being studied for how it may assist in repairing some of the lost function from the spinal cord injury, and if it can restore some of this lost function.
More detailed information may be found at clinicaltrials.gov.