Trials / Not Yet Recruiting
Not Yet RecruitingNCT06995625
The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA)
An Open-Label, Single-Arm, Dose Escalation Phase I Clinical Trial to Evaluate the Safety and Tolerability of SNE-101 in Patients With Acute Ischemic Stroke
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- Sponsor
- S&Ebio Co. Ltd. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter open-label, single-arm, dose escalation phase I clinical trial to evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke
Detailed description
The study aims to assess the safety, tolerability, and preliminary efficacy of allogeneic Wharton's jelly-mesenchymal stem cell-derived extracellular vesicles (EVs) in patients with acute ischemic stroke.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SNE-101 | Experimental: Cohort 1 - SNE-101 4.8 × 10e10 particles (n=3 to 6) Experimental: Cohort 2 - SNE-101 9.6 × 10e10 particles (n=3 to 6) Experimental: Cohort 3 - SNE-101 19.2 × 10e10 particles (n=3 to 6) |
Timeline
- Start date
- 2025-08-01
- Primary completion
- 2026-03-31
- Completion
- 2027-03-31
- First posted
- 2025-05-29
- Last updated
- 2025-08-01
Locations
3 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT06995625. Inclusion in this directory is not an endorsement.