NeuroRise: Intrathecal CE-1 Treatment for Traumatic SCI

NCT07739043 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: CE1-101-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SCI - Spinal Cord Injury; SCI; Spinal Cord Injury

Keywords

Stem cells; Spinal cord injury; Mesenchymal stem cells

Outcome Measures

Primary Outcomes (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

  From enrollment to the end of 6-month follow-up

Secondary Outcomes (1)

• The proportion of participants receiving a single intrathecal injection of CE-1 who had significant functional improvement

  From enrollment to 6-months post-treatment

Study Arms (1)

CE-1

EXPERIMENTAL

Allogenic Umbilical Cord-Derived Mesenchymal Stem Cells

Drug: Human allogeneic, culture expanded, UC-MSC

Interventions

Human allogeneic, culture expanded, UC-MSC DRUG

A weight-based intrathecal dose

CE-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Full understanding of the requirements of their rehabilitation program prescribed by physical and occupational therapists.
• Injury within 10 years before enrollment or screening period. Both acute and chronic SCI patients may be enrolled. Chronic SCI is defined as at least one year post-injury with stabilized neurological function.
• The participant must be able to tolerate intrathecal injections.
• The participant must have negative serology for HIV, VDRL, Hepatitis B and C
• Adequate vital organ function defined by normal laboratory values for creatinine, ALT, AST, total bilirubin, NT-ProBNP. If these labs are out of range, they must be reviewed by PI and confirmed. Rescreening can be done after treatment and retesting.
• Blood platelets count equal to or higher than 100,000 /μL and INR level equal to or less than 1.5 must be encountered.

You may not qualify if:

• 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.
• Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment.
• Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis, and syphilis.
• Fever, defined as temperature above 99ºF/37.2ºC or mental confusion at the time of IPA.
• Clinically significant cardiovascular (e.g., history of myocardial infarction, congestive heart failure or uncontrolled hypertension \> 90 mmHg diastolic and/or 180 mmHg systolic), neurological (e.g., stroke, TIA) renal, hepatic or endocrine disease (e.g., diabetes, osteoporosis).
• History of malignancy including melanoma except for localized skin cancers (with no evidence of metastasis, significant invasion, or re-occurrence within three years of baseline). Any other malignancy will not be allowed. Provided they have not demonstrated clinical signs or symptoms of infection and have not required treatment, participants with large granular lymphocytic leukemia, upon consultation with their Hematologist/Oncologist, may be considered but should undergo additional testing at screening.
• History of blood dyscrasia, including but not limited to anemia, thrombocytopenia, and monoclonal gammopathy.
• History of bleeding disorders and actual levels of blood platelet lower than 100,000/μL and/or INR equal to or higher than 1.5.

Sponsors & Collaborators

• Cell Therapy LLC: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Senior Program Coordinator

CONTACT

(507) 218-7764; fatima.soltan@neuroinnovations.co

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

US (1)