DOSED Study: Evaluating a Delivery Device for LCTOPC1 in Spinal Cord Injury
This study, called DOSED, is testing a new way to deliver a cell therapy called LCTOPC1 to people with spinal cord injuries. LCTOPC1 is designed to help replace or support cells damaged by injury, with the goal of improving quality of life and function. You might be able to join if you are 18-65 years old and have a traumatic spinal cord injury (either complete or sensory incomplete) in your neck (cervical) or upper back (thoracic) region. The injury must have happened between 21 and 42 days ago (subacute) or between 1 and 5 years ago (chronic). The main goal of this study is to see how safe the delivery device and injection procedure are. This study plans to enroll 10 participants, but its current recruitment status is unclear.
- Study design
- This is a Phase 1b, open-label study, meaning both you and the study team will know what treatment you are receiving. It will enroll 10 participants.
- What's involved
- You will receive one injection of 10 million LCTOPC1 cells into your spinal cord. The first four patients will be enrolled one after another after safety checks.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be monitored for long-term safety for up to 10 years after receiving LCTOPC1. The frequency and severity of adverse events related to the delivery device or injection procedure will be measured one month after the injection.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Evaluate the Safety of a Delivery Device for Administering LCTOPC1 in Participants With Spinal Cord Injury
At a glance
Conditions
Where it's being run
2 sites across 1 statesWho to contact
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What this trial measures
- Frequency and Severity of Adverse Events Related to the Delivery Device or Injection Procedure Through 30 DaysOne month after LCTOPC1 injection
Frequency and severity of the MI PSD System or injection procedure related adverse events (AEs) through 30 days (1 month).