NeuroRise: Intrathecal CE-1 Treatment for Traumatic SCI

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Cell Therapy LLC
Study ID
NCT07739043
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • SCI
  • SCI - Spinal Cord Injury
  • Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Human allogeneic, culture expanded, UC-MSC — DRUG
    A weight-based intrathecal dose

Study Details

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.

Key Dates

First listed
Jul 31, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: CE-1
    Allogenic Umbilical Cord-Derived Mesenchymal Stem Cells

Primary Outcome Measure

The incidence, nature, and severity of adverse events after the administration of a single intrathecal injection of CE-1 in participants with traumatic SCI [ Time Frame: From enrollment to the end of 6-month follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of ChicagoChicagoIllinois60637-

Find similar trials in Chicago, IL

By research site
The University of Chicago· Chicago, IL

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