Health TrialsbyHealthPanel

The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA)

ConditionAcute Ischemic Stroke AIS
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorS&Ebio Co. Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults with 19 years or older

Patients within 5 days of symptom onset who have not received thrombolytic therapy or undergone endovascular reperfusion procedures.

Patients within 5 days of symptom onset who have received thrombolytic therapy or undergone endovascular reperfusion procedures but show no clinical recovery after 2 days of observation.

Infarction within the middle cerebral artery territory on diffusion-weighted imaging (DWI)

Disqualifiers

Pre-stroke disability (pre-stroke mRS ≥ 2)

No longer meeting the NIHSS inclusion criteria 48 hours post-thrombolysis or endovascular therapy

Lacunar stroke due to small vessel occlusion

SAFE (Shoulder Abduction and Finger Extension) score ≥ 5

Trial design

Design model

Single group

Treatments tested in this trial

  • SNE-101

    Drug

    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)

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: SNE-101Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke and determine the Maximum Tolerated Dose (MTD)

o The Maximum Tolerated Dose (MTD) determination via the Dose limiting toxicity (DLT)

Time frame
MTD: within 19 days after first dose
2

To evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke and determine the Maximum Tolerated Dose (MTD)

o Adverse events are monitored continuously throughout the study.

Time frame
Adverse events: 180 days

Secondary outcomes

1

To assess the efficacy of SNE-101 in patients with acute ischemic stroke.

o Mean % change in Fugl-Meyer Assessment (FMA) from baseline to Week 13 A quantitative measure used to assess motor function, balance, and joint motion in post-stroke patients. The FMA is a widely validated scale used to evaluate sensorimotor recovery, especially in the upper and lower extremities, with a maximum score of 226 indicating normal function. Higher scores indicate better motor recovery.

Time frame
13 weeks
2

To assess the efficacy of SNE-101 in patients with acute ischemic stroke.

o Improvement in neural tract integrity on Diffusion Tensor Imaging (DTI) from baseline to Week 13. An advanced MRI technique used to assess the integrity and organization of white matter tracts in the brain. DTI parameters such as fractional anisotropy (FA) and mean diffusivity (MD) provide quantitative measures of axonal regeneration and neuroplasticity. Increases in FA and normalization of MD values are indicative of neural recovery after stroke.

Time frame
13 weeks
3

To assess the efficacy of SNE-101 in patients with acute ischemic stroke.

o Changes in NIH stroke scale (NIHSS) from baseline to Week 13 A standardized neurological examination that quantifies the severity of neurological impairment caused by stroke. The NIHSS evaluates several domains including consciousness, motor strength, language, vision, and sensory loss. Scores range from 0 to 42, with lower scores indicating milder neurological deficits.

Time frame
13 weeks
4

To assess the efficacy of SNE-101 in patients with acute ischemic stroke.

o Changes in modified Rankin Score (mRS) from baseline to Week 13 A global functional outcome scale that assesses the degree of disability or dependence in daily activities in patients who have suffered a stroke. Scores range from 0 (no symptoms) to 6 (death). Lower scores indicate greater functional independence and are commonly used as primary endpoints in stroke trials.

Time frame
13 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

S&Ebio Co. Ltd.

Lead sponsor

Source ClinicalTrials.gov
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