Ischemic StrokePhase 1NCT05697718

Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cells (IxCell hUC-MSC-S) in the Treatment of Ischemic Stroke

A Phase 1 study testing MSC in people with Ischemic Stroke, run by Shanghai IxCell Biotechnology Co., LTD at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the safety and tolerability of IxCellhUC-MSC-S as a single intravenous infusion in convalescent patients with ischemic stroke. To explore the efficacy of IxCellhUC-MSC-S as a single intravenous infusion in patients with convalescent ischemic stroke. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Ischemic Stroke
What is being tested?: MSC
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 2 sitesChina
Study dates: 10 Apr 2023to 27 Aug 2024
Phase: Phase 1
Are there results?: None posted in the registry

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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 to 80 years old, both sexes;
Diagnosed with ischemic stroke of the anterior circulation at 12-24 weeks after the first stroke symptom onset (including W12 and W24);
National Institutes of Health Stroke Scale (NIHSS) score 6-20 points, and NlHSS score item 1a < 2 points;
Life expectancy ≥ 12 months;
Understand and comply with the study process, with informed consent form voluntarily signed by the patient or the authorized representatives.

Who cannot join

Current or previous epilepsy, dementia, Parkinson's disease, major depression, or other neurological disorders or mental illnesses that the investigator believes will affect their ability to participate in the study or affect the study evaluation;
Current or past intracranial hemorrhagic diseases (such as: cerebral hemorrhage, epidural hematoma, subdural hematoma, subarachnoid hemorrhage, ventricle hemorrhage, traumatic cerebral hemorrhage, etc.) or cerebral tumors, history of brain trauma, encephalitis and other symptoms leading to apoplexy;
Current or past severe cardiovascular disease；
Patients with pulmonary embolism, interstitial pneumonia, radiation pneumonia, drug-related pneumonia, severe impairment of lung function and other severe lung infections or other lung diseases (except those caused by stroke, bed rest after stroke or stroke treatment);
Have any other clinically serious medical conditions currently or in the past that the investigators judge unsuitable for inclusion in this study, including but not limited to severe liver (e.g., cirrhosis, etc.), kidney (e.g., kidney diseases requiring hemodialysis or peritoneal dialysis, etc.), blood (e.g., hemophilia with bleeding tendencies, etc.), endocrine (e.g.,Diabetes mellitus with difficult blood glucose control (blood glucose > 16.8mmol/L or < 2.8mmol/L), or complicated with severe neurovascular complications, etc.), immune system (active or uncontrolled autoimmune diseases, primary or secondary immune deficiencies, etc.), malignant tumors (except cured non-melanoma skin cancer, cervical or breast ductal carcinoma in situ), etc.;
Organ function level meet the following any one or more:

Show all 18Show fewer

absolute neutrophil cell count (ANC) < 1.5×109/L, platelet (PLT) < 100×109/L, hemoglobin (Hb) < 90g/L; Aspertate aminotransferase (AST) > 2.5×normal limit (ULN) and/or alanine aminotransferase (ALT) > 2.5×ULN, serum total bilirubin (TBIL) > 1.5×ULN; Creatinine (Cr) > 1.5×ULN; The international normalized ratio (INR) for those who did not receive anticoagulant or antithrombotic therapy > 1.7 or activated partial thromboplastin time (APTT) > 1.25×ULN, the international normalized ratio(INR) for those using anticoagulant or antithrombotic therapy > 3.0 or activated partial thromboplastin time (APTT) > 1.50×ULN.
Hepatitis B virus surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive for HBV-DNA, positive for hepatitis C virus antibody (HCVAb), treponema pallidum antibody (TPAb/RPR) or human immunodeficiency virus antibody (HIV), or within 14 days prior to receiving the test drug treatment,The emergence of any infected persons in need of systematic anti-infective treatment;
Allergic constitution or history, or allergic to the test drug or any component of the test drug;
Patients with MRI contraindications;
Positive blood pregnancy test results for female subjects of reproductive age within 7 days prior to receiving the experimental drug treatment;All women of reproductive age, fertile men or their spouses who refused to use appropriate contraception (including at least one barrier contraceptive) throughout the study period, and lactating women;
Those who required systemic corticosteroids (> 10mg/ day prednisone therapeutic dose) or other immunosuppressive agents within 14 days prior to receiving the trial drug or during the study period;
Patients who used butylphthalein within 3 weeks before receiving the experimental drug;
participated in any clinical trial and took any investigational drug within 3 months prior to receiving the investigational drug treatment (or the last time receiving the investigational drug did not exceed 5 half-lives, whichever is longer);
Patients who had severe trauma or major surgery within 3 months before receiving the experimental drug treatment, or who plan to undergo surgery during the trial period;Patients with a history of blood transfusion within 3 months before receiving the experimental drug treatment;
Those who had a history of drug abuse or alcoholism within 1 year before receiving the experimental drug treatment;
Those who have previously received other stem cell treatments;
Participants with other severe, acute, or chronic medical conditions that may increase the patient's risk or may interfere with the interpretation of the test results are judged by the investigator to be unsuitable for clinical trials.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality
Xuanwu Hospital of Capital Medical University
Beijing

Other trials in China

About this study

Official title: A Phase I Study of Safety and Tolerability of Single-dose Human Umbilical Cord Mesenchymal Stem Cell (IxCell hUC-MSC-S) in Patients With Convalescent Phase of Ischemic Stroke

To evaluate the safety and tolerability of IxCellhUC-MSC-S as a single intravenous infusion in convalescent patients with ischemic stroke.

To explore the efficacy of IxCellhUC-MSC-S as a single intravenous infusion in patients with convalescent ischemic stroke.

Read the detailed description

MSCs are a type of stem cells derived from mesoderm with multidirectional differentiation potential. Studies have shown that MSCs have the potential to differentiate not only to bone, cartilage, fat and myogenic cells, but also to neurons.Among them, human cord blood mesenchymal stem cells are a kind of mature mesenchymal stem cells currently used. Human cord blood mesenchymal stem cells are ideal seed cells for tissue engineering. In addition to the advantages of convenient acquisition, rich source, easy expansion, etc., human cord blood collection also has the following advantages: (1) Collection of cord blood has no harm to maternal and newborn;(2) The cells are more primitive and have stronger ability of proliferation and differentiation;(3) Low immunogenicity, strong tolerance to human leukocyte antigen and low incidence of rejection;(4) The infection and transmission probability of tumor cells, viruses and pathogenic microorganisms is relatively low;(5) It does not involve many controversies in social, ethical and legal aspects.Current studies believe that the possible mechanisms of human umbilical cord mesenchymal stem cells in the treatment of stroke include replacing damaged nerve cells, promoting the proliferation and differentiation of endogenous nerve cells, secreting neurotrophic factors, promoting angiogenesis, reducing nerve cell apoptosis, and inhibiting inflammation.

Conditions: Ischemic Stroke
Being tested: MSC
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MSCBiological
a single injection dose i.v.

Study groups in NCT05697718
Study group	Role	What they receive
group 1	Experimental	Human umbilical cord mesenchymal stem cells（hMSCs）5.0×10^7 cells Receives: Biological: MSC
group 2	Experimental	Human umbilical cord mesenchymal stem cells（hMSCs）10.0×10^7 cells Receives: Biological: MSC
group 3	Experimental	Human umbilical cord mesenchymal stem cells（hMSCs）20.0×10^7 cells Receives: Biological: MSC

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and tolerability
Adverse events and serious adverse events
Measured: 24 weeks
Laboratory test：blood routine
Measured: 24 weeks
Laboratory test：urine routine
Measured: 24 weeks
Laboratory test：blood biochemistry
Measured: 24 weeks
Laboratory test：coagulation function
Measured: 24 weeks
12-lead electrocardiogram
Measured: 24 weeks
Head magnetic resonance imaging（MRI）
Measured: 24weeks
Physical examination
Measured: 24weeks

Secondary outcomes (6)

Preliminary efficacy
Changes in mRS scores at W12 and W24 compared to baseline after administration
Measured: 24 weeks
Preliminary efficacy
The proportion of patients with a Barthel index (BI) score of ≥95 at W12 and W24 after administration
Measured: 24 weeks
Preliminary efficacy
Changes in Barthel index (BI) at W12 and W24 compared to baseline after administration
Measured: 24 weeks
Preliminary efficacy
Changes in the National Institutes of Health Stroke Scale (NIHSS) at W12 and W24 after administration compared to baseline
Measured: 24 weeks
Preliminary efficacy
Changes in Fugl-Meyer（FM）scores at W12 and W24 compared to baseline after administration
Measured: 24 weeks
Preliminary efficacy
Changes in infarct volume on MRI (FLAIR sequence) at W12 and W24 after administration compared to baseline
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 202327 Aug 2024

First posted26 Jan 2023
Study start10 Apr 2023
Primary completion29 Jul 2024
Study completion27 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05697718
Sponsor's protocol ID: LC-MSC-IS21004
Status last verified: Dec 2025
First submitted: 27 Dec 2022
Last updated: 12 Feb 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Cui L, Xiao M, Zhang Q, Liu H, Ren Y, Ma G, Zhou D, Ma Q, Yao H, Lin M, Gao D, Ye L, Wang R, Wang Y, Zhang L, Zhong L, Gao G, Chen J, Jolkkonen J, Boltze J, Hao J. Intravenous human umbilical cord-derived mesenchymal stem cell transplantation for ischemic stroke (MERIT): A phase 1 trial. Cell Rep Med. 2026 Jun 16;7(6):102836. doi: 10.1016/j.xcrm.2026.102836. Epub 2026 May 28.
PubMed 42208543

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Study of Safety and Tolerability of Single-dose Human Umbilical Cord Mesenchymal Stem Cell (IxCell hUC-MSC-S) in Patients With Convalescent Phase of Ischemic Stroke
ClinicalTrials.gov ID: NCT05697718
Acronym / sponsor ID: LC-MSC-IS21004
Conditions: Ischemic Stroke
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Shanghai IxCell Biotechnology Co., LTDUniversity, hospital or other
Study start: 10 Apr 2023 (actual)
Primary completion: 29 Jul 2024 (actual)
Study completion: 27 Aug 2024 (actual)
First posted: 26 Jan 2023 (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.

To evaluate the safety and tolerability of IxCellhUC-MSC-S as a single intravenous infusion in convalescent patients with ischemic stroke.

To explore the efficacy of IxCellhUC-MSC-S as a single intravenous infusion in patients with convalescent ischemic stroke.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
group 1	Experimental	Biological: MSCHuman umbilical cord mesenchymal stem cells（hMSCs）5.0×10^7 cells
group 2	Experimental	Biological: MSCHuman umbilical cord mesenchymal stem cells（hMSCs）10.0×10^7 cells
group 3	Experimental	Biological: MSCHuman umbilical cord mesenchymal stem cells（hMSCs）20.0×10^7 cells

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

18 to 80 years old, both sexes;
Diagnosed with ischemic stroke of the anterior circulation at 12-24 weeks after the first stroke symptom onset (including W12 and W24);
National Institutes of Health Stroke Scale (NIHSS) score 6-20 points, and NlHSS score item 1a < 2 points;
Life expectancy ≥ 12 months;
Understand and comply with the study process, with informed consent form voluntarily signed by the patient or the authorized representatives.

Key exclusion criteria (18 listed)

Current or previous epilepsy, dementia, Parkinson's disease, major depression, or other neurological disorders or mental illnesses that the investigator believes will affect their ability to participate in the study or affect the study evaluation;
Current or past intracranial hemorrhagic diseases (such as: cerebral hemorrhage, epidural hematoma, subdural hematoma, subarachnoid hemorrhage, ventricle hemorrhage, traumatic cerebral hemorrhage, etc.) or cerebral tumors, history of brain trauma, encephalitis and other symptoms leading to apoplexy;
Current or past severe cardiovascular disease；
Patients with pulmonary embolism, interstitial pneumonia, radiation pneumonia, drug-related pneumonia, severe impairment of lung function and other severe lung infections or other lung diseases (except those caused by stroke, bed rest after stroke or stroke treatment);
Have any other clinically serious medical conditions currently or in the past that the investigators judge unsuitable for inclusion in this study, including but not limited to severe liver (e.g., cirrhosis, etc.), kidney (e.g., kidney diseases requiring hemodialysis or peritoneal dialysis, etc.), blood (e.g., hemophilia with bleeding tendencies, etc.), endocrine (e.g.,Diabetes mellitus with difficult blood glucose control (blood glucose > 16.8mmol/L or < 2.8mmol/L), or complicated with severe neurovascular complications, etc.), immune system (active or uncontrolled autoimmune diseases, primary or secondary immune deficiencies, etc.), malignant tumors (except cured non-melanoma skin cancer, cervical or breast ductal carcinoma in situ), etc.;

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
MSCa single injection dose i.v.	Biological	group 1, group 2, group 3

Primary outcome

Safety and tolerability
Time frame: 24 weeks
Adverse events and serious adverse events
Laboratory test：blood routine
Time frame: 24 weeks
Laboratory test：urine routine
Time frame: 24 weeks
Laboratory test：blood biochemistry
Time frame: 24 weeks
Laboratory test：coagulation function
Time frame: 24 weeks
12-lead electrocardiogram
Time frame: 24 weeks
Head magnetic resonance imaging（MRI）
Time frame: 24weeks
Physical examination
Time frame: 24weeks

6 secondary outcomes

Preliminary efficacy
Time frame: 24 weeks
Preliminary efficacy
Time frame: 24 weeks
Preliminary efficacy
Time frame: 24 weeks
Preliminary efficacy
Time frame: 24 weeks
Preliminary efficacy
Time frame: 24 weeks
Preliminary efficacy
Time frame: 24 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
Derived from this study: PubMed 42208543Cui L, Xiao M, Zhang Q, Liu H, Ren Y, Ma G, Zhou D, Ma Q, Yao H, Lin M, Gao D, Ye L, Wang R, Wang Y, Zhang L, Zhong L, Gao G, Chen J, Jolkkonen J, Boltze J, Hao J. Intravenous human umbilical cord-derived mesenchymal stem cell transplantation for ischemic stroke (MERIT): A phase 1 trial. Cell Rep Med. 2026 Jun 16;7(6):102836. doi: 10.1016/j.xcrm.2026.102836. Epub 2026 May 28.

Related trials for Ischemic Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
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Recruiting
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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. This study is not recruiting at the moment.

junwei Hao, Doctor principal investigator

Xuanwu Hospital of Capital Medical University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MSC in people with Ischemic Stroke, run by Shanghai IxCell Biotechnology Co., LTD at 2 sites in China.

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 5 inclusion and 18 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: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability (time frame: 24 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05697718, which also lists 1 linked publication.

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 12 Feb 2026.