Acute Ischemic StrokePhase 1UMERISNCT06518902
Umbilical Cord-derived Mesenchymal Stem Cell Infusion for Treating Acute Ischemic Stroke
A Phase 1 study testing mesenchymal stem cells (umbilical cord) injection in people with Acute Ischemic Stroke, run by National Engineering Center of Cell Products.
Trial summary
The goal of this clinical trial is to learn if drug mesenchymal stem cells (umbilical cord) injection works to treat acute ischemic stroke in adults. It will also learn about the safety and efficacy of drug mesenchymal stem cells (umbilical cord) injection . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- mesenchymal stem cells (umbilical cord) injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Dec 2025
- 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
- Age range of 18-80 years old (including threshold), gender not limited;
- The clinical diagnosis of this episode is anterior circulation ischemic stroke, confirmed by MRI/CT, and the patient can receive experimental drugs within one month after the onset of stroke symptoms;
- Individuals with a National Institutes of Health Stroke Scale (NIHSS) score of 6-20 (inclusive) and a NIHSS score of Ia<2 points;
- Female subjects with fertility or male subjects with fertility partners who have no fertility plans and voluntarily take effective contraceptive measures during the study period;
- Individuals with self-reported or family reported mRS scores of 0 or 1 prior to the onset of current stroke symptoms;
- After receiving complete information about the study, all participants voluntarily participate in the clinical study by signing an informed consent form themselves or their guardians.
Who cannot join
- Individuals with epilepsy, Alzheimer's disease, Parkinson's disease, severe depression, or other neurological disorders or mental illnesses that researchers believe may affect their ability to participate in trials or impact research evaluations;
- Bleeding transformation occurred, and according to the researchers' judgment, it is not suitable to participate in clinical trials;
- Patients with malignant tumors, excluding low-grade malignant tumors such as basal cell carcinoma, papillary thyroid carcinoma, and localized prostate cancer in situ, who have received curative treatment for more than five years;
- Serious infections, including sepsis, septic shock, severe pneumonia (diagnostic criteria for severe pneumonia refer to the 2007 American College of Infectious Diseases/American Thoracic Society diagnostic criteria for adult severe pneumonia), etc;
- Patients with respiratory failure, or those with current evidence of pulmonary embolism or suspected pulmonary embolism;
- Organ function levels that meet any one or more of the following criteria:
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- ALT or AST>2 × ULN; TBil>1.5×ULN； Scr>2×ULN；
- Thrombocytopenia (platelet count<75000/mm3) or heparin induced thrombocytopenia;
- For patients who have not received anticoagulant therapy, activated partial thromboplastin time (APTT)>2.5 × ULN or prothrombin time (PT)>2.5 × ULN; Patients who have received anticoagulant therapy and have been assessed by researchers to have a serious risk of bleeding;
- Hemoglobin (Hb)<90g/L;
- Individuals who have had or currently have severe cardiovascular disease:
- Suffering from CTCAE grade II or above myocardial ischemia or myocardial infarction, or unstable angina pectoris;
- Researchers believe that severe arrhythmias with clinical significance;
- NYHA standard III-IV cardiac dysfunction;
- Other acute and severe complications that endanger life;
- Poorly controlled hypertensive patients (defined as those who have undergone antihypertensive treatment but have sustained systolic blood pressure>220mmHg or diastolic blood pressure>120mmHg);
- Poorly controlled diabetes (defined as blood glucose still>16.8 mmol/L after treatment) or hypoglycemia (blood glucose<2.8 mmol/L);
- Individuals with a history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, idiopathic IgA deficiency, or those who require systemic steroid hormone (≥ 10 mg/day of prednisone equivalent)/immunosuppressive drug treatment within 14 days prior to or during the trial period;
- Patients who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), as well as positive for HBV DNA, hepatitis C antibody (HCV), or Treponema pallidum antibody (TPAb/PRR);
- Screening individuals who have participated in clinical trials of other drugs within the previous 3 months;
- Individuals known to be allergic to the investigational drug or any component of the investigational drug (including human serum albumin, dimethyl sulfoxide, or compound electrolyte injection, as well as bovine derived products);
- Individuals who are unable to undergo cranial CT/MRI examination due to various reasons;
- Patients who have undergone major surgery, suffered severe trauma, or plan to undergo neurological function assessment during the trial period within the 3 months prior to the first administration of medication;
- Breastfeeding or pregnant women (pregnancy diagnosis is evaluated through a combination of blood pregnancy test/urine pregnancy test and/or obstetric ultrasound examination);
- Combining other serious systemic diseases, or having a medical history of any disease or laboratory abnormality that may confuse the study results, interfere with subject participation in the study procedure, or not be in the best interest of subject participation in the study, based on the researcher's judgment, is not suitable for inclusion.
About this study
Official title: A Single Arm, Open Label Exploratory Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of Mesenchymal Stem Cells (Umbilical Cord) Injection in the Treatment of Acute Ischemic Stroke (AIS) Patients
The goal of this clinical trial is to learn if drug mesenchymal stem cells (umbilical cord) injection works to treat acute ischemic stroke in adults. It will also learn about the safety and efficacy of drug mesenchymal stem cells (umbilical cord) injection . The main questions it aims to answer are:
Identify the dose-limiting toxicity (DLT) of drug mesenchymal stem cells (umbilical cord) injection in acute ischemic stroke patients.
Read more
Dose the drug mesenchymal stem cells (umbilical cord) injection improves the mRS score, NIHSS score, Fugl-Meyer score and and Barthel index of acute ischemic stroke patients? What is the pharmacokinetic characteristics and immunogenic response of mesenchymal stem cells (umbilical cord) injection in the treatment of acute ischemic stroke patients.
What is the the possible molecular mechanisms of mesenchymal stem cells (umbilical cord) injection in the treatment of acute ischemic stroke patients.
Participants will:
Take drug drug mesenchymal stem cells (umbilical cord) injection once or once a week for three consecutive weeks.
After receiving the corresponding dose of mesenchymal stem cells (umbilical cord) injection, the subjects entered a 6-month safety, efficacy observation and further safety evaluation period. Long term efficacy and survival follow-up up to 2 years.
- Conditions
- Acute Ischemic Stroke
- Being tested
- mesenchymal stem cells (umbilical cord) injection
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal stem cells (umbilical cord) injectionDrug
Patients receive mesenchymal stem cells (umbilical cord) injection once or once a week for three consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| MSCs group | Experimental | mesenchymal stem cells (umbilical cord) injection once or once a week for three consecutive weeks. Receives: Drug: mesenchymal stem cells (umbilical cord) injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
Dose-limiting toxicity and Maximum tolerated dose
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Engineering Center of Cell Products
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518902
- Sponsor's protocol ID
- MSCTAISP-01
- Acronym
- UMERIS
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open Label Exploratory Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of Mesenchymal Stem Cells (Umbilical Cord) Injection in the Treatment of Acute Ischemic Stroke (AIS) Patients
- ClinicalTrials.gov ID
- NCT06518902
- Acronym / sponsor ID
- UMERIS / MSCTAISP-01
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- National Engineering Center of Cell ProductsUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Jul 2024 (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.
The goal of this clinical trial is to learn if drug mesenchymal stem cells (umbilical cord) injection works to treat acute ischemic stroke in adults. It will also learn about the safety and efficacy of drug mesenchymal stem cells (umbilical cord) injection . The main questions it aims to answer are:
Identify the dose-limiting toxicity (DLT) of drug mesenchymal stem cells (umbilical cord) injection in acute ischemic stroke patients.
Dose the drug mesenchymal stem cells (umbilical cord) injection improves the mRS score, NIHSS score, Fugl-Meyer score and and Barthel index of acute ischemic stroke patients? What is the pharmacokinetic characteristics and immunogenic response of mesenchymal stem cells (umbilical cord) injection in the treatment of acute ischemic stroke patients.
What is the the possible molecular mechanisms of mesenchymal stem cells (umbilical cord) injection in the treatment of acute ischemic stroke patients.
Participants will:
Take drug drug mesenchymal stem cells (umbilical cord) injection once or once a week for three consecutive weeks.
After receiving the corresponding dose of mesenchymal stem cells (umbilical cord) injection, the subjects entered a 6-month safety, efficacy observation and further safety evaluation period. Long term efficacy and survival follow-up up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSCs group | Experimental | Drug: mesenchymal stem cells (umbilical cord) injectionmesenchymal stem cells (umbilical cord) injection once or once a week for three consecutive weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age range of 18-80 years old (including threshold), gender not limited;
- The clinical diagnosis of this episode is anterior circulation ischemic stroke, confirmed by MRI/CT, and the patient can receive experimental drugs within one month after the onset of stroke symptoms;
- Individuals with a National Institutes of Health Stroke Scale (NIHSS) score of 6-20 (inclusive) and a NIHSS score of Ia<2 points;
- Female subjects with fertility or male subjects with fertility partners who have no fertility plans and voluntarily take effective contraceptive measures during the study period;
- Individuals with self-reported or family reported mRS scores of 0 or 1 prior to the onset of current stroke symptoms;
Key exclusion criteria (25 listed)
- Individuals with epilepsy, Alzheimer's disease, Parkinson's disease, severe depression, or other neurological disorders or mental illnesses that researchers believe may affect their ability to participate in trials or impact research evaluations;
- Bleeding transformation occurred, and according to the researchers' judgment, it is not suitable to participate in clinical trials;
- Patients with malignant tumors, excluding low-grade malignant tumors such as basal cell carcinoma, papillary thyroid carcinoma, and localized prostate cancer in situ, who have received curative treatment for more than five years;
- Serious infections, including sepsis, septic shock, severe pneumonia (diagnostic criteria for severe pneumonia refer to the 2007 American College of Infectious Diseases/American Thoracic Society diagnostic criteria for adult severe pneumonia), etc;
- Patients with respiratory failure, or those with current evidence of pulmonary embolism or suspected pulmonary embolism;
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 |
|---|---|---|
| mesenchymal stem cells (umbilical cord) injectionPatients receive mesenchymal stem cells (umbilical cord) injection once or once a week for three consecutive weeks | Drug | MSCs group |
Primary outcome
Dose-limiting toxicity
Time frame: 6 months
Dose-limiting toxicity and Maximum tolerated dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mesenchymal stem cells (umbilical cord) injection in people with Acute Ischemic Stroke, run by National Engineering Center of Cell Products.
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 6 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Dose-limiting toxicity (time frame: 6 months). 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 25 Jul 2024.