ARTEMIS: Umbilical Cord-Derived Mesenchymal Stromal Cells (UC-MSCs) After Mechanical Thrombectomy for Acute Ischemic Stroke
A legfontosabb adatok
- Ki végzi
- Royan Stem Cell Technology Company
- Hol
- Tehran (Irán)A helyszín megnézése
- Azonosító
- NCT07913282
- IRCT20260922071161N1
- Állapot
- Toborzás még nem indult
- Fázis
- 1. fázis
- Résztvevők
- 10 fő, tervezett
- Kezdés
- 2026. nov. 20.
- Várható befejezés
- 2028. jún. 20.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Allogeneic Umbilical Cord-Derived Mesenchymal Stromal Cells (UC-MSCs)
- Standard Stroke Care Including Mechanical Thrombectomy
- A regiszteradat frissítve
- 2026. november 12.
Ki vehet részt
- Életkor
- 18 év – 70 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 23 feltétel megnézéseKevesebb
Ki vehet részt
- 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
- National Institutes of Health Stroke Scale (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
Ki nem vehet részt
- Previous stroke
- 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
- Uncontrolled blood glucose
- 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
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 70 év között vagy?
Helyszínek itt: Irán
- Firoozgar hospitalTehran, IránContact: Supervisor of Interventional Cath LabNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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 MSCs derived from allogeneic 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.
A vizsgálat 2 csoportja
- Allogeneic UC-MSCs Plus Standard CareA vizsgált kezelés
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.
Kezelés: Allogeneic Umbilical Cord-Derived Mesenchymal Stromal Cells (UC-MSCs) és Standard Stroke Care Including Mechanical Thrombectomy
- Standard Care AloneMár használt kezelés, összehasonlításként
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.
Kezelés: Standard Stroke Care Including Mechanical Thrombectomy
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- 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
- Illeszkedési kérdések
- Forrás: NCT07913282: ki vehet részt
- A regiszteradat frissítve
- 2026. november 12.