NCT07913282Not yet recruitingPhase 1
ARTEMIS: UC-MSCs After Mechanical Thrombectomy for Acute Ischemic Stroke
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 28 Oct 2026
- Start date
- 20 Nov 2026
- Primary completion date
- 20 Nov 2027
- Lead sponsor
- Royan Stem Cell Technology Company
- Diseases
- Stroke
- NCT number
- NCT07913282
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 10
- From 20 Nov 2026 to the primary completion date, 20 Nov 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 stroke;
Other illness
- Subarachnoid, intraventricular, or intracerebral hemorrhage, or a structural brain lesion such as a tumor, on CT or MRI;
- Known coagulation or hematologic disorder (e.g., aplastic anemia) or current anticoagulant use (e.g., warfarin);
- Known hepatic, renal, or heart failure;
- Myocardial infarction within the past 6 months;
- History of seizures within the past 6 months;
- History of cancer;
- Known intellectual, cognitive (e.g., dementia) or psychiatric disorder that would impair understanding of, or adherence to, study procedures and follow-up;
- Allergy to contrast media.
Lab values
- Uncontrolled blood glucose;
Other
- Infarct in the cerebellum or brainstem;
- Small lacunar infarct (lesion smaller than 15-20 mm);
- Midline shift, cerebral edema, or an infarct in an inaccessible location on CT or MRI;
- Candidate for decompressive craniectomy;
- Pregnancy or breastfeeding;
Who the study is looking for
- Age 18 to 70 years;
- Acute ischemic stroke diagnosed clinically;
- Acute ischemic stroke confirmed by CT or MRI;
- Eligible for mechanical thrombectomy that can be performed within six hours of symptom onset;
- NIHSS score from 6 to 20;
- Pre-stroke modified Rankin Scale (mRS) score less than 2;
- Successful reperfusion (mTICI 2b or 3) on angiography after thrombectomy;
- Written informed consent from the patient or a legally authorized representative.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Firoozgar hospital Coordinator of this site? Confirm its status | Tehran | Iran | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.