SCI - Spinal Cord InjuryEarly Phase 1NeuroRiseNCT07739043
NeuroRise: Intrathecal CE-1 Treatment for Traumatic SCI
A Early Phase 1 study testing Human allogeneic, culture expanded, UC-MSC in people with SCI - Spinal Cord Injury and SCI, run by Cell Therapy LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCI - Spinal Cord Injury, SCI, Spinal Cord Injury
- What is being tested?
- Human allogeneic, culture expanded, UC-MSC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
- History or presence of brain injury, hydrocephalus, meningitis, cerebral palsy, altered consciousness, signs/symptoms of neurodegenerative disorders (e.g., stroke, amyotrophic lateral sclerosis, multiple sclerosis, etc.), based on medical history and at the discretion of the investigator.
- Participation in a study of an experimental drug or medical device within 3 months of study enrollment
- Known allergy to local anesthetics of other components of the study drug.
- Any contraindication to MRI scan according to MRI guidelines, or unwillingness to undergo MRI procedures.
- History of or current evidence of alcohol or drug abuse or dependence, recreational use of an illicit drug or prescription medications, or use of medical marijuana within 28 days of study entry
- Diagnosis of schizophrenia or bipolar disorder
- Participants with untreated baseline depression, diagnosed by the Beck Depression Inventory, past medical history, and baseline assessment conducted by a psychologist or a psychiatrist. Participants with depression or anxiety disorders who are in remission or receiving treatment can be enrolled in the study.
- Any severe condition pre-existing before or after traumatic SCI at the discretion of the Principal Investigator (PI).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm and Open Labeled Clinical Study of CE1 (Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells, or UC-MSC) in Traumatic Spinal Cord Injury Patients Within Ten Years of Injury
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:
Read more
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
- Being tested
- Human allogeneic, culture expanded, UC-MSC
- Keywords
- Stem cells, Spinal cord injury, Mesenchymal stem cells
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human allogeneic, culture expanded, UC-MSCDrug
A weight-based intrathecal dose
| Study group | Role | What they receive |
|---|---|---|
| CE-1 | Experimental | Allogenic Umbilical Cord-Derived Mesenchymal Stem Cells Receives: Drug: Human allogeneic, culture expanded, UC-MSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence, nature, and severity of adverse events after the administration of a single intrathecal injection of CE-1 in participants with traumatic SCI
Measured: 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
Measured: From enrollment to 6-months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cell Therapy LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739043
- Sponsor's protocol ID
- CE1-101-01
- Acronym
- NeuroRise
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm and Open Labeled Clinical Study of CE1 (Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells, or UC-MSC) in Traumatic Spinal Cord Injury Patients Within Ten Years of Injury
- ClinicalTrials.gov ID
- NCT07739043
- Acronym / sponsor ID
- NeuroRise / CE1-101-01
- Conditions
- SCI - Spinal Cord Injury, SCI, Spinal Cord Injury
- Keywords
- Stem cells, Spinal cord injury, Mesenchymal stem cells
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Cell Therapy LLCUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CE-1 | Experimental | Drug: Human allogeneic, culture expanded, UC-MSCAllogenic Umbilical Cord-Derived Mesenchymal Stem Cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human allogeneic, culture expanded, UC-MSCA weight-based intrathecal dose | Drug | CE-1 |
Primary outcome
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
1 secondary outcome
The proportion of participants receiving a single intrathecal injection of CE-1 who had significant functional improvement
Time frame: From enrollment to 6-months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Human allogeneic, culture expanded, UC-MSC in people with SCI - Spinal Cord Injury and SCI, run by Cell Therapy LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Senior Program Coordinator ((507) 218-7764, fatima.soltan@neuroinnovations.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.