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ARTEMISNCT07913282

ARTEMIS: UC-MSCs After Mechanical Thrombectomy for Acute Ischemic Stroke

StatusNot Yet Recruiting
PhasePhase 1
Primary completion (estimated)
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Incidence of Serious Adverse Events (SAEs)
Timeframe: During the intervention and 1 hour, 24 hours, 3 days, 7 days, 1 month, 3 months, and 6 months after the intervention
Incidence of Adverse Events (AEs)
Timeframe: During the intervention and 1 hour, 24 hours, 3 days, 7 days, 1 month, 3 months, and 6 months after the intervention.
Feasibility of Intra-Arterial UC-MSC Administration
Timeframe: During the intervention (Day 0)

Secondary (6)

Proportion of Participants with mRS 0-2
Proportion of Participants with a Reduction in mRS Score Compared with the Initial Pre-Treatment Assessment
Change in National Institutes of Health Stroke Scale (NIHSS) from baseline
Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Concentration
Change in Serum Matrix Metalloproteinase-9 (MMP-9) Concentration
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Change in Serum S100B Concentration

Arms and interventions

Allogeneic UC-MSCs Plus Standard CareExperimental

Participants in the experimental group will receive standard emergency care for acute ischemic stroke, including mechanical thrombectomy. Following successful thrombectomy and angiographic confirmation of reperfusion, a single dose of 20 × 10⁶ allogeneic umbilical cord-derived mesenchymal stromal cells is administered intra-arterially into the artery supplying the infarcted territory during the same procedure. Thereafter, participants will receive routine post-stroke care and physical rehabilitation.

Standard Care AloneActive comparator

Participants in the control group will receive standard emergency care for acute ischemic stroke, including mechanical thrombectomy performed using the same procedural approach as in the experimental group. Following thrombectomy, participants will receive routine post-stroke care and physical rehabilitation. No cell infusion will be administered.

Biologicals: Allogeneic Umbilical Cord-Derived Mesenchymal Stromal Cells (UC-MSCs)

Procedures: Standard Stroke Care Including Mechanical Thrombectomy

Sites

1 site in 1 country

  • Firoozgar hospitalTehran, Tehran Province, Iran