Acute Ischemic StrokePhase 1ARTEMISNCT07913282
ARTEMIS: UC-MSCs After Mechanical Thrombectomy for Acute Ischemic Stroke
A Phase 1 study testing Allogeneic Umbilical Cord-Derived Mesenchymal Stromal Cells (UC-MSCs) and Standard Stroke Care Including Mechanical Thrombectomy in people with Acute Ischemic Stroke, run by Royan Stem Cell Technology Company at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Allogeneic Umbilical Cord-Derived Mesenchymal Stromal Cells (UC-MSCs) and Standard Stroke Care Including Mechanical Thrombectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIran
- Study dates
- 20 Nov 2026to 20 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Previous stroke;
- Infarct in the cerebellum or brainstem;
- Small lacunar infarct (lesion smaller than 15-20 mm);
- Subarachnoid, intraventricular, or intracerebral hemorrhage, or a structural brain lesion such as a tumor, on CT or MRI;
- Midline shift, cerebral edema, or an infarct in an inaccessible location on CT or MRI;
- Candidate for decompressive craniectomy;
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- Known coagulation or hematologic disorder (e.g., aplastic anemia) or current anticoagulant use (e.g., warfarin);
- Uncontrolled blood glucose;
- 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;
- Pregnancy or breastfeeding;
- Allergy to contrast media.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site
Firoozgar hospital
Tehran, Tehran Province, 1593748711
Supervisor of Interventional Cath Lab, 02182141000, dr.f.ebrahimnia@gmail.com
About this study
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
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.
Read more
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.
Read the detailed description
- 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Allogeneic Umbilical Cord-Derived Mesenchymal Stromal Cells (UC-MSCs), Standard Stroke Care Including Mechanical Thrombectomy
- Keywords
- Acute Ischemic Stroke, Mechanical Thrombectomy, Umbilical Cord-Derived Mesenchymal Stromal Cells, UC-MSCs, Intra-Arterial Cell Therapy, Cell-Based Therapy, Cerebral Reperfusion, Safety and Feasibility, phase I
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Umbilical Cord-Derived Mesenchymal Stromal Cells (UC-MSCs)Biological
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 Stroke Care Including Mechanical ThrombectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic UC-MSCs Plus Standard Care | Experimental | 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. Receives: Biological: Allogeneic Umbilical Cord-Derived Mesenchymal Stromal Cells (UC-MSCs); Procedure: Standard Stroke Care Including Mechanical Thrombectomy |
| Standard Care Alone | Active 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. Receives: Procedure: Standard Stroke Care Including Mechanical Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Serious Adverse Events (SAEs)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: During the intervention (Day 0)
Secondary outcomes (6)
Proportion of Participants with mRS 0-2
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)
Measured: 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
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.)
Measured: Baseline, 24 hours, 3 days, 7 days, 1, 3, and 6 months
Change in National Institutes of Health Stroke Scale (NIHSS) from baseline
Change from baseline in National Institutes of Health Stroke Scale score. NIHSS ranges from 0 to 42; higher scores mean more severe neurological deficit.
Measured: Baseline, 24 hours, 3 days, 7 days, 1, 3, and 6 months
Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Concentration
Change in serum BDNF concentration from baseline, measured using the protocol-specified laboratory assay and compared between the intervention and control groups.
Measured: Baseline, 3 days, and 6 months after intervention.
Change in Serum Matrix Metalloproteinase-9 (MMP-9) Concentration
Change in serum MMP-9 concentration from baseline, measured using the protocol-specified laboratory assay and compared between the intervention and control groups.
Measured: Baseline, 3 days, and 6 months after intervention.
Change in Serum S100B Concentration
Change in serum S100B concentration from baseline, measured using the protocol-specified laboratory assay and compared between the intervention and control groups.
Measured: Baseline, 3 days, and 6 months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start20 Nov 2026 (estimated)
- Primary completion20 Nov 2027 (estimated)
- Study completion20 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, randomized, two-arm, parallel-group, open-label, phase I controlled trial
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royan Stem Cell Technology Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royan Institute, Firuzgar hospital affiliated to Iran University of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Dr. Massoud Vosough, MD-PhD, Principal investigator, Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.Dr. Feiz Ebrahimnia, MD, Neurovascular intervention, Principal investigator, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913282
- Sponsor's protocol ID
- ARTEMIS405000020
- Other IDs
- IRCT20260922071161N1
- Acronym
- ARTEMIS
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07913282
- Acronym / sponsor ID
- ARTEMIS / ARTEMIS405000020
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Mechanical Thrombectomy, Umbilical Cord-Derived Mesenchymal Stromal Cells, UC-MSCs, Intra-Arterial Cell Therapy, Cell-Based Therapy, Cerebral Reperfusion, Safety and Feasibility
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Royan Stem Cell Technology CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Royan Institute, Firuzgar hospital affiliated to Iran University of Medical Sciences
- Study start
- 20 Nov 2026 (estimated)
- Primary completion
- 20 Nov 2027 (estimated)
- Study completion
- 20 Jun 2028 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, randomized, two-arm, parallel-group, open-label, phase I controlled trial
| Arm | Type | Receives |
|---|---|---|
| Allogeneic UC-MSCs Plus Standard Care | Experimental | Biological: Allogeneic Umbilical Cord-Derived Mesenchymal Stromal Cells (UC-MSCs), Procedure: Standard Stroke Care Including Mechanical ThrombectomyParticipants 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 Alone | Active comparator | Procedure: Standard Stroke Care Including Mechanical ThrombectomyParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (15 listed)
- Previous stroke;
- Infarct in the cerebellum or brainstem;
- Small lacunar infarct (lesion smaller than 15-20 mm);
- Subarachnoid, intraventricular, or intracerebral hemorrhage, or a structural brain lesion such as a tumor, on CT or MRI;
- Midline shift, cerebral edema, or an infarct in an inaccessible location on CT or MRI;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Allogeneic UC-MSCs Plus Standard Care |
| Standard Stroke Care Including Mechanical ThrombectomyStandard 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. | Procedure or surgery | Allogeneic UC-MSCs Plus Standard Care, Standard Care Alone |
Primary outcome
Incidence of Serious Adverse Events (SAEs)
Time frame: 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.
Incidence of Adverse Events (AEs)
Time frame: 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.
Feasibility of Intra-Arterial UC-MSC Administration
Time frame: 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.
6 secondary outcomes
Proportion of Participants with mRS 0-2
Time frame: 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
Time frame: Baseline, 24 hours, 3 days, 7 days, 1, 3, and 6 months
Change in National Institutes of Health Stroke Scale (NIHSS) from baseline
Time frame: Baseline, 24 hours, 3 days, 7 days, 1, 3, and 6 months
Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Concentration
Time frame: Baseline, 3 days, and 6 months after intervention.
Change in Serum Matrix Metalloproteinase-9 (MMP-9) Concentration
Time frame: Baseline, 3 days, and 6 months after intervention.
Change in Serum S100B Concentration
Time frame: Baseline, 3 days, and 6 months after intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Massoud Vosough, MD-PhD principal investigator
Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Dr. Feiz Ebrahimnia, MD, Neurovascular intervention principal investigator
Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Allogeneic Umbilical Cord-Derived Mesenchymal Stromal Cells (UC-MSCs) and Standard Stroke Care Including Mechanical Thrombectomy in people with Acute Ischemic Stroke, run by Royan Stem Cell Technology Company at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elaheh Khodadoust, MD-MPH (+989121216987, elaheh.khodadoust@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Serious Adverse Events (SAEs) (time frame: During the intervention and 1 hour, 24 hours, 3 days, 7 days, 1 month, 3 months, and 6 months after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.