Ischemic StrokePhase 1/2NCT03915431
A Study of NCS-01 in Patients With Acute Ischemic Stroke
A Phase 1/2 study testing NCS-01 in people with Ischemic Stroke, run by NC Medial Research Inc at 1 site in United States.
Trial summary
This is an initial Phase1/2 dose-finding, randomized, multi-center study to evaluate the safety and tolerability of NCS-01 in patients with acute ischemic stroke. All patients will be randomized within 48 hours of stroke onset. This study will be conducted in 2 stages. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- NCS-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2020to Oct 2028
- Phase
- Phase 1/2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, age 18 to 85 years inclusive
- Clinical evidence of acute ischemic unilateral cerebral infarction
- - Evidence of neurologic deficits as defined by NIHSS 6 to 18 or NIHSS < 6 with Fugl-Meyer upper extremity subtotal 6 to 40 inclusive
- Women of child bearing potential who agrees to take acceptable birth control as described in the ICF
- Provide written informed consent before participation, either by patient or a legal representative
Who cannot join
- Progressive neurologic deficit
- An inability to undergo an MRI scan
- Any malignancies within the last 5 years
- Previous organ transplantation
- Participation in another clinical trial with an investigational drug, device or biologic within the preceding 3 months
- Women of childbearing potential with a positive pregnancy test
Show all 9Show fewer
- Already dependent in activities of daily living (Rankin scale 3 or more) before the present acute stroke
- Known hypersensitivity, allergy or intolerance to the similar biologic interventions
- Any other clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with study objectives judged by Investigator based on medical history, physical examination, laboratory tests and/or ECG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1/2 Randomized Study to Evaluate the Safety and Tolerability of Intracarotid Artery Administration of NCS-01 in Patients With Acute Ischemic Stroke
This is an initial Phase1/2 dose-finding, randomized, multi-center study to evaluate the safety and tolerability of NCS-01 in patients with acute ischemic stroke. All patients will be randomized within 48 hours of stroke onset. This study will be conducted in 2 stages.
- Conditions
- Ischemic Stroke
- Being tested
- NCS-01
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCS-01Biological
single infusion
| Study group | Role | What they receive |
|---|---|---|
| NCS-01 | Experimental | human bone marrow derived cells Receives: Biological: NCS-01 |
| sham | Sham comparator | sham procedure Receives: Biological: NCS-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events -Safety by Incidence of Treatment-Emergent Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" . Incidence and nature of adverse events; vital signs;
Measured: multiple times for the duration of the study (baseline through Month 12)
National Institutes of Health Stroke Scale (NIHSS)
Change from baseline in the NIHSS NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The score for each ability is a number between 0 and 4, 0 being normal functioning and 4 being completely impaired. The patient's NIHSS score is calculated by adding the number for each element of the scale; 42 is the highest score possible. In the NIHSS, the higher the score, the more impaired a stroke patient is.
Measured: 1 hour, 3 hours, and 6 hours post infusion
Number of participants with change in in physical examination
physical examination changes General appearance ,Head, eyes, ears, nose, and throat, Respiratory, Cardiovascular, Musculoskeletal, Abdomen, Neurologic, Extremities, Dermatologic, Lymphatic)
Measured: multiple times from baseline through Month 12
Number of participants with change in Electrocardiography (ECG)
ECG (standard digital 12-lead in singlicate)
Measured: multiple times for the duration of the study (baseline through Month 12)
Number of participants with change in clinical laboratory evaluations
changes in clinical laboratory evaluations (Creatinine, Potassium(K+),Sodium (Na+) , Chloride (Cl-), Magnesium (Mg++), Calcium, Inorganic phosphate, Glucose, Urea,Bilirubin (Total) ,Bilirubin (direct), AST, ALT, GGT, Alkaline phosphatase, Total Protein Albumin,
Measured: multiple times for the duration of the study (baseline through Month 12)
Secondary outcomes (4)
Number of participants with change in Modified Rankin Scale (mRS)
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke.Score Description 0 No symptoms at all
- No significant disability despite symptoms; able to carry out all usual duties and activities
- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
- Moderate disability; requiring some help, but able to walk without assistance
- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
- Severe disability; bedridden, incontinent and requiring constant nursing care and attention
- Dead
Measured: multiple times for the duration of the study (baseline through Month 12)
Number of participants with change in Cytokine panel (IL-1, 6, 8, etc.)
blood test for proteins that modulate the inflammatory response
Measured: multiple times for the duration of the study (baseline through Month 12)
Number of participants with change in MRI
global white matter and grey matter volumetrics; cortical thinning on MRI
Measured: multiple times for the duration of the study (baseline through Month 12)
Number of participants with change in Barthel Index
Barthel Index is a 4 point scale of Activities of Daily Living
Measured: multiple times for the duration of the study (baseline through Month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start27 Feb 2020
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NC Medial Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean Savitz, md, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915431
- Sponsor's protocol ID
- NCS-01-01
- Status last verified
- Sep 2025
- First submitted
- 9 Apr 2019
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Randomized Study to Evaluate the Safety and Tolerability of Intracarotid Artery Administration of NCS-01 in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03915431
- Acronym / sponsor ID
- NCS-01-01
- Conditions
- Ischemic Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- NC Medial Research IncIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 16 Apr 2019 (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.
This is an initial Phase1/2 dose-finding, randomized, multi-center study to evaluate the safety and tolerability of NCS-01 in patients with acute ischemic stroke. All patients will be randomized within 48 hours of stroke onset. This study will be conducted in 2 stages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NCS-01 | Experimental | Biological: NCS-01human bone marrow derived cells |
| sham | Sham comparator | Biological: NCS-01sham procedure |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females, age 18 to 85 years inclusive
- Clinical evidence of acute ischemic unilateral cerebral infarction
- - Evidence of neurologic deficits as defined by NIHSS 6 to 18 or NIHSS < 6 with Fugl-Meyer upper extremity subtotal 6 to 40 inclusive
- Women of child bearing potential who agrees to take acceptable birth control as described in the ICF
- Provide written informed consent before participation, either by patient or a legal representative
Key exclusion criteria (9 listed)
- Progressive neurologic deficit
- An inability to undergo an MRI scan
- Any malignancies within the last 5 years
- Previous organ transplantation
- Participation in another clinical trial with an investigational drug, device or biologic within the preceding 3 months
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 |
|---|---|---|
| NCS-01single infusion | Biological | NCS-01, sham |
Primary outcome
Number of participants with adverse events -Safety by Incidence of Treatment-Emergent Adverse Events
Time frame: multiple times for the duration of the study (baseline through Month 12)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" . Incidence and nature of adverse events; vital signs;
National Institutes of Health Stroke Scale (NIHSS)
Time frame: 1 hour, 3 hours, and 6 hours post infusion
Change from baseline in the NIHSS NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The score for each ability is a number between 0 and 4, 0 being normal functioning and 4 being completely impaired. The patient's NIHSS score is calculated by adding the number for each element of the scale; 42 is the highest score possible. In the NIHSS, the higher the score, the more impaired a stroke patient is.
Number of participants with change in in physical examination
Time frame: multiple times from baseline through Month 12
physical examination changes General appearance ,Head, eyes, ears, nose, and throat, Respiratory, Cardiovascular, Musculoskeletal, Abdomen, Neurologic, Extremities, Dermatologic, Lymphatic)
Number of participants with change in Electrocardiography (ECG)
Time frame: multiple times for the duration of the study (baseline through Month 12)
ECG (standard digital 12-lead in singlicate)
Number of participants with change in clinical laboratory evaluations
Time frame: multiple times for the duration of the study (baseline through Month 12)
changes in clinical laboratory evaluations (Creatinine, Potassium(K+),Sodium (Na+) , Chloride (Cl-), Magnesium (Mg++), Calcium, Inorganic phosphate, Glucose, Urea,Bilirubin (Total) ,Bilirubin (direct), AST, ALT, GGT, Alkaline phosphatase, Total Protein Albumin,
4 secondary outcomes
Number of participants with change in Modified Rankin Scale (mRS)
Time frame: multiple times for the duration of the study (baseline through Month 12)
Number of participants with change in Cytokine panel (IL-1, 6, 8, etc.)
Time frame: multiple times for the duration of the study (baseline through Month 12)
Number of participants with change in MRI
Time frame: multiple times for the duration of the study (baseline through Month 12)
Number of participants with change in Barthel Index
Time frame: multiple times for the duration of the study (baseline through Month 12)
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 11 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sean Savitz, md principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NCS-01 in people with Ischemic Stroke, run by NC Medial Research Inc 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 5 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events -Safety by Incidence of Treatment-Emergent Adverse Events (time frame: multiple times for the duration of the study (baseline through Month 12)). The study lists 5 primary outcomes in all. 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 11 Sep 2025.