NCT03915431Active, not recruitingPhase 1/2
A Study of NCS-01 in Patients With Acute Ischemic Stroke
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
Source: ClinicalTrials.gov · Last updated 11 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 9 Apr 2019
- Start date
- 27 Feb 2020
- Primary completion date
- Oct 2027
- Lead sponsor
- NC Medial Research Inc
- Diseases
- Stroke
- NCT number
- NCT03915431
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 16
- From 27 Feb 2020 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous organ transplantation
- Participation in another clinical trial with an investigational drug, device or biologic within the preceding 3 months
Other illness
- Any malignancies within the last 5 years
- 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
Lab values
- 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
Other
- Progressive neurologic deficit
- An inability to undergo an MRI scan
- Women of childbearing potential with a positive pregnancy test
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.