NeuroRise: Intrathecal CE-1 Treatment for Traumatic SCI
United States8 participantsStarted 2026-09
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Once the voluntary nature of the study is explained in detail, the participant must be willing to provide written informed consent and complete HIPAA documentation before conducting any study-related procedure. A signed written informed consent and ability to comply with the study protocol according to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and local regulations is required.
. Male or female aged 18 years and older at the time of enrollment
. Females of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal/barrier method or abstinence) from the time of screening to a period of 1 year following completion of the drug treatment cycle. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than two years. If the urine pregnancy test is positive, the study drug will not be administered, and the result will be confirmed by a serum β-hCG test. β-hCG tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using a kit.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence, nature, and severity of adverse events after the administration of a single intrathecal injection of CE-1 in participants with traumatic SCI
Timeframe: From enrollment to the end of 6-month follow-up
. Females becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcomes. Any serious adverse events (SAE) associated with pregnancy will be recorded.
. SCI categorized as either complete (AIS grade A) or incomplete (AIS grade B, C or D) at the time of recruitment.
. Injuries located below the C2 level confirmed by MR imaging.
. SCI must be traumatic, blunt/non-penetrating in nature, and not degenerative.
. Full understanding of the requirements of the study and willingness to comply with the treatment plan, laboratory tests, diagnostic imaging, complete physical and neurologic examination, and follow-up visits and assessments.
Exclusion criteria
. Pregnant or nursing, or planning on becoming pregnant during the study period
. SCI initially classified as AIS grade E at the time of injury
. SCI located above C2 level confirmed by magnetic resonance imaging (MRI).
. History of receiving MSC, gene or exosome therapy for any indications
. History of intra-spinal infection
. History of superficial infection in the index spinal level within 6 months of enrollment
. Evidence of current superficial infection affecting the index spinal level at the time of enrollment
. On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including chronic use of systemic steroids/corticosteroids. Use of steroids/corticosteroids in the acute SCI phase is permissible but the participant must have been off steroids for at least 14 days prior to the first injection and cannot take steroids for at least one month after injection.