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NOT YET RECRUITING
NCT07913282
PHASE1

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

Sponsor: Royan Stem Cell Technology Company

View on ClinicalTrials.gov

Summary

This study will evaluate the safety and feasibility of administering umbilical cord-derived mesenchymal stromal cells (UC-MSCs) following mechanical thrombectomy in adults with acute ischemic stroke. Acute ischemic stroke occurs when a blood clot blocks blood flow to part of the brain, potentially causing brain tissue damage and neurological impairment. The study will include 10 adults aged 18 to 70 years. All participants will receive standard stroke care, including mechanical thrombectomy to remove the blood clot. Participants will be randomly assigned to one of two groups. One group will receive standard care plus a single dose of 20 million UC-MSCs derived from donated umbilical cord tissue. The cells will be delivered through a microcatheter into the artery supplying the affected part of the brain. The other group will receive standard care without the cell treatment. Both groups will receive physical rehabilitation. Researchers will follow participants for six months. They will monitor health problems and assess recovery, disability, blood markers, and brain scans. The main goal is to determine whether this treatment can be administered safely and feasibly. It is not yet known whether the treatment will improve recovery after stroke.

Official title: ARTEMIS: Safety and Feasibility of Intra-arterial Administration of Allogeneic Umbilical Cord-Derived Mesenchymal Stromal Cells (UC-MSCs) After Mechanical Thrombectomy in Acute Ischemic Stroke - A Phase I Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-11-20

Completion Date

2028-06-20

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

BIOLOGICAL

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

Allogeneic mesenchymal stromal cells derived from Wharton's jelly of donated full-term umbilical cords. A single dose of 20 × 10⁶ cells suspended in 20 mL of normal saline is administered through a microcatheter into the artery supplying the infarcted area following successful reperfusion after mechanical thrombectomy.

PROCEDURE

Standard Stroke Care Including Mechanical Thrombectomy

Standard emergency care for acute ischemic stroke, including mechanical thrombectomy to remove the occluding blood clot, followed by routine post-thrombectomy care and physical rehabilitation according to the study protocol.

Locations (1)

Firoozgar hospital

Tehran, Tehran Province, Iran