Intrathecal CE-1 for Spinal Cord Injury
(NeuroRise Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to assess the safety and tolerability of intrathecal administration of CE-1 at a weight-based dose (cells/kg BW), capped at a maximum total dose of 1×10⁸ cells in 10 mL, with administered volume calculated using M = 0.167 mL/kg BW.
Study details include:
The overall study duration will be up to three years. The primary endpoint will be assessed at 6 months following investigational product administration. An additional secondary endpoint will be assessed at 12 months in the form of a phone call.
Study visits therefore consist of one interventional visit, an evaluation visit within two weeks post-injection, a primary endpoint follow-up visit at 6 months, and a secondary endpoint follow-up phone call at 12-months.
Are You a Good Fit for This Trial?
This trial is for people with a traumatic spinal cord injury. Participants must meet specific medical criteria set by the study team, but detailed inclusion and exclusion rules are not provided here.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Human allogeneic, culture expanded, UC-MSC
Trial Overview
The study tests the safety of CE-1, a treatment made from donor umbilical cord stem cells (UC-MSC), given through an injection into the spine. The dose depends on body weight and there will be follow-ups over one year.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Allogenic Umbilical Cord-Derived Mesenchymal Stem Cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cell Therapy LLC
Lead Sponsor
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