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

28 oktober 2026 uppdaterad av: Royan Stem Cell Technology Company

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

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

- Scientific Rationale: Acute ischemic stroke results from an interruption of cerebral blood flow, causing ischemic injury and potentially persistent neurological disability. Mechanical thrombectomy restores blood flow by removing the occluding thrombus; however, successful reperfusion does not necessarily prevent secondary tissue injury or subsequent neurological impairment. Umbilical cord-derived mesenchymal stromal cells (UC-MSCs) possess immunomodulatory and tissue-repair properties that provide a scientific rationale for investigating their therapeutic potential following ischemic stroke. The safety and feasibility of intra-arterial administration after mechanical thrombectomy during the acute phase require further clinical evaluation.

- Study Overview and Procedures:

ARTEMIS (ARterial ThErapy with Mesenchymal stromal cells In Stroke) is a Phase 1 randomized, controlled clinical trial evaluating the safety and feasibility of intra-arterial administration of allogeneic UC-MSCs following mechanical thrombectomy. The study will include ten adults aged 18-70 years with imaging-confirmed acute ischemic stroke, a National Institutes of Health Stroke Scale (NIHSS) score of 6-20, and a prestroke modified Rankin Scale (mRS) score below 2. Participants must be eligible for mechanical thrombectomy within six hours of symptom onset and achieve successful reperfusion, defined as a modified Thrombolysis in Cerebral Infarction (mTICI) grade of 2b-3. Key exclusions include previous stroke, cerebellar or brainstem stroke, intracranial hemorrhage or major structural brain lesions, significant coagulation disorders, severe uncontrolled comorbidities, recent myocardial infarction, seizures, cancer, pregnancy or breastfeeding, contrast-agent allergy, and conditions that prevent informed participation or reliable follow-up. Written informed consent will be obtained from participants or their legally authorized representatives.

Participants will be randomly allocated in a 1:1 ratio to receive standard stroke care alone or standard care supplemented with cell administration. The randomization sequence will be generated using the Sealed Envelope platform, as specified in the study protocol.

In the intervention group, cell administration will take place after angiographic confirmation of successful reperfusion. The cells will be delivered through a microcatheter into the main artery supplying the infarcted territory. Repeat angiography will be performed after administration to assess for vascular occlusion or hemorrhage. Both groups will receive routine post-thrombectomy care and physical rehabilitation.

- Investigational Product:

The allogeneic UC-MSC product, called Whartocell®, is manufactured under Good Manufacturing Practice (GMP) conditions and has approval for cerebral palsy (CP) and osteoarthritis indications.

The investigational product consists of allogeneic mesenchymal stromal cells isolated from Wharton's jelly tissue obtained from donated full-term umbilical cords following the required consent procedures. Umbilical cord tissue will be collected under sterile conditions and processed to isolate the stromal cell population and will undergo product characterization and quality-control testing.

- Safety Monitoring:

Participants will undergo clinical monitoring throughout the study and follow-up period. Adverse events will be documented and evaluated for severity, duration, and potential relationship to the investigational product or study procedures. The protocol specifies the use of the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0), for safety monitoring.

Serious adverse events and suspected unexpected serious adverse reactions will be managed and reported according to the study protocol and applicable institutional requirements. Safety information will be reviewed by the clinical team and the Data and Safety Monitoring Board (DSMB), as specified in the protocol.

- Study Objectives:

This early-phase clinical investigation aims to establish preliminary evidence regarding the safety and feasibility of intra-arterial UC-MSC administration following mechanical thrombectomy during the acute phase of stroke. The findings may inform the design of subsequent clinical studies evaluating cell-based interventions for acute ischemic stroke. The study is exploratory and is not intended to establish definitive therapeutic efficacy.

Studietyp

Interventionell

Inskrivning (Beräknad)

10

Fas

  • Fas 1

Kontakter och platser

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Studiekontakt

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Studieorter

    • Tehran Province
      • Tehran, Tehran Province, Iran, 1593748711
        • Firoozgar hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. Age 18 to 70 years;
  2. Acute ischemic stroke diagnosed clinically;
  3. Acute ischemic stroke confirmed by CT or MRI;
  4. Eligible for mechanical thrombectomy that can be performed within six hours of symptom onset;
  5. NIHSS score from 6 to 20;
  6. Pre-stroke modified Rankin Scale (mRS) score less than 2;
  7. Successful reperfusion (mTICI 2b or 3) on angiography after thrombectomy;
  8. Written informed consent from the patient or a legally authorized representative.

Exclusion Criteria:

  1. Previous stroke;
  2. Infarct in the cerebellum or brainstem;
  3. Small lacunar infarct (lesion smaller than 15-20 mm);
  4. Subarachnoid, intraventricular, or intracerebral hemorrhage, or a structural brain lesion such as a tumor, on CT or MRI;
  5. Midline shift, cerebral edema, or an infarct in an inaccessible location on CT or MRI;
  6. Candidate for decompressive craniectomy;
  7. Known coagulation or hematologic disorder (e.g., aplastic anemia) or current anticoagulant use (e.g., warfarin);
  8. Uncontrolled blood glucose;
  9. Known hepatic, renal, or heart failure;
  10. Myocardial infarction within the past 6 months;
  11. History of seizures within the past 6 months;
  12. History of cancer;
  13. Known intellectual, cognitive (e.g., dementia) or psychiatric disorder that would impair understanding of, or adherence to, study procedures and follow-up;
  14. Pregnancy or breastfeeding;
  15. Allergy to contrast media.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Allogeneic UC-MSCs Plus Standard Care

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.

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.

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.

Aktiv komparator: Standard Care Alone

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.

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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of Serious Adverse Events (SAEs)
Tidsram: During the intervention and 1 hour, 24 hours, 3 days, 7 days, 1 month, 3 months, and 6 months after the intervention

Number of participants experiencing one or more serious adverse events during follow-up, including events resulting in death, life-threatening conditions, prolonged hospitalization, persistent or significant disability, or requiring medical or surgical intervention to prevent such outcomes. Event severity and relationship to the study intervention will be assessed by the clinical team.

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)
Tidsram: During the intervention and 1 hour, 24 hours, 3 days, 7 days, 1 month, 3 months, and 6 months after the intervention.

The frequency, type, severity, and relatedness of adverse events associated with intra-arterial infusion of allogeneic umbilical cord-derived mesenchymal stromal cells after mechanical thrombectomy based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.

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
Tidsram: During the intervention (Day 0)

Feasibility will be assessed by the proportion of participants assigned to the intervention group in whom the planned intra-arterial infusion of 20 × 10⁶ allogeneic UC-MSCs is successfully completed according to the study protocol. The number of successful and unsuccessful administrations will be recorded, together with reasons for any failure to initiate or complete the infusion.

During the intervention (Day 0)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of Participants with mRS 0-2
Tidsram: Baseline, 24 hours, 3 days, 7 days, 1, 3, and 6 months

Number and percentage of participants with a modified Rankin Scale (mRS) score of 0-2 in each study group, comparing the UC-MSC group with the control group. (mRS ranges from 0 (no symptoms) to 6 (death); higher scores mean greater disability)

Baseline, 24 hours, 3 days, 7 days, 1, 3, and 6 months
Proportion of Participants with a Reduction in mRS Score Compared with the Initial Pre-Treatment Assessment
Tidsram: Baseline, 24 hours, 3 days, 7 days, 1, 3, and 6 months

Number and percentage of participants achieving a reduction in the modified Rankin Scale (mRS) score, compared between the intervention and control groups. (mRS ranges from 0 (no symptoms) to 6 (death); higher scores mean greater disability.)

Baseline, 24 hours, 3 days, 7 days, 1, 3, and 6 months
Change in National Institutes of Health Stroke Scale (NIHSS) from baseline
Tidsram: Baseline, 24 hours, 3 days, 7 days, 1, 3, and 6 months

Change from baseline in National Institutes of Health Stroke Scale score. NIHSS ranges from 0 to 42; higher scores mean more severe neurological deficit.

Baseline, 24 hours, 3 days, 7 days, 1, 3, and 6 months
Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Concentration
Tidsram: Baseline, 3 days, and 6 months after intervention.

Change in serum BDNF concentration from baseline, measured using the protocol-specified laboratory assay and compared between the intervention and control groups.

Baseline, 3 days, and 6 months after intervention.
Change in Serum Matrix Metalloproteinase-9 (MMP-9) Concentration
Tidsram: Baseline, 3 days, and 6 months after intervention.

Change in serum MMP-9 concentration from baseline, measured using the protocol-specified laboratory assay and compared between the intervention and control groups.

Baseline, 3 days, and 6 months after intervention.
Change in Serum S100B Concentration
Tidsram: Baseline, 3 days, and 6 months after intervention.

Change in serum S100B concentration from baseline, measured using the protocol-specified laboratory assay and compared between the intervention and control groups.

Baseline, 3 days, and 6 months after intervention.

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes in Cerebral Infarct Volume on CT/MRI
Tidsram: Initial presentation, 24 hours, and 6 months after intervention,

Cerebral infarct core volume will be assessed using brain imaging according to the study protocol. Imaging findings will be evaluated to characterize changes in the extent of cerebral injury during follow-up.

Initial presentation, 24 hours, and 6 months after intervention,

Samarbetspartners och utredare

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Sponsor

Samarbetspartners

Utredare

  • Huvudutredare: Dr. Massoud Vosough, MD-PhD, Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
  • Huvudutredare: Dr. Feiz Ebrahimnia, MD, Neurovascular intervention, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

20 november 2026

Primärt slutförande (Beräknad)

20 november 2027

Avslutad studie (Beräknad)

20 juni 2028

Studieregistreringsdatum

Först inskickad

28 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

28 oktober 2026

Första postat (Faktisk)

3 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • ARTEMIS405000020
  • IRCT20260922071161N1 (Annan identifierare: Iranian Registry of Clinical Trials)

Plan för individuella deltagardata (IPD)

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OBESLUTSAM

IPD-planbeskrivning

The decision to share individual participant data will be made after completion of the study. Data may be made available for non-commercial research purposes, including systematic reviews, meta-analyses, and the design of future clinical trials, upon submission of a written request and approval by the Principal Investigator.

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