Stem Cell Therapy for Intracerebral Hemorrhage

Launched by TANG ZHOUPING · Mar 2, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring the use of stem cell therapy to treat patients with intracerebral hemorrhage (ICH), a type of bleeding in the brain that can lead to serious health issues and long-term disability. Specifically, the trial will focus on a type of stem cell called human umbilical cord mesenchymal stem cells (UC-MSCs), which have shown promise in previous studies for reducing brain swelling and promoting recovery in patients with ICH. The goal is to determine if this treatment is safe and effective for patients who are in the subacute phase of ICH, which is typically between 3 to 10 days after the bleeding starts.

To participate in this trial, individuals need to be between 18 and 65 years old and have a confirmed diagnosis of ICH within the specified time frame. They should have a certain level of brain function and good overall health, as indicated by specific medical tests. Participants can expect to receive the stem cell treatment and will be monitored closely throughout the study to assess their health and recovery. It’s important to note that this trial is not yet recruiting participants, so anyone interested should keep an eye out for updates.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-65 years old, gender is not limited.
• • 2. Clinically confirmed intracerebral hemorrhage during the subacute period (3 days-10 days after onset).
• • 3. CT confirmed as cerebral parenchymal hemorrhage, ABC/2 method to calculate the episodic hemorrhage volume of 15-30 mL (ABC/2 method hematoma volume calculation formula V (cm3) =A×B×C×1/2, A is the longest diameter of the largest level of the hematoma in the horizontal position of the CT scan (cm), B is the widest diameter of the hematoma in this plane perpendicular to the A (cm), C is the thickness of the hematoma appearing in the CT film (cm)).
• • 4. Blood biochemical indexes meet the following conditions: 1) good coagulation function, international normalized ratio (INR) \<2; 2) alachlor aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times the upper limit of the normal value, and total bilirubin \<2 times the upper limit of the normal value; 3) creatinine clearance \>50 mL/min; 4) hemoglobin \>90 g/L; 5) absolute neutrophil value (ANC) ≥ 1.5×10\^9/L, absolute lymphocyte count ≥0.4×10\^9/L, platelet count ≥80×10\^9/L, and albumin \>25g/L; 6) procalcitonin (PCT) ≤2ng/mL.
• • 5. National Institutes of Health Stroke Scale score (NIHSS) ≥5 and ≤20.
• • 6. Pre-onset modified Ranking Scale score (mRS) ≤1.
• • 7. Glasgow Coma Score (GCS) ≥9 points and ≥3 points on a single item.
• • 8. Good compliance, signed informed consent by the person and/or legal guardian and able to receive follow-up visits at the specified time.
• Exclusion Criteria:
• • 1. Brain midline deviation \>10 mm or brain hernia formation.
• • 2. Patients who have undergone or intend to undergo surgical treatment to remove hematoma.
• • 3. Secondary intracerebral hemorrhage caused by traumatic brain injury, arteriovenous malformation, intracranial aneurysm, coagulation disorders, hemorrhagic transformation after cerebral infarction, or tumors.
• • 4. Suffering from malignant tumors, autoimmune diseases (including but not limited to systemic lupus erythematosus, systemic vasculitis, etc.), hemorrhagic predisposition diseases (including all kinds of hereditary hemorrhagic disorders and acquired hemorrhagic diseases), malignant cardiac arrhythmia, cardiac insufficiency (BNP ≥1000pg/mL or left ventricular ejection fraction ≤40%), acute myocardial infarction, acute or severe infectious diseases (such as intracranial infection, severe pneumonia, sepsis, etc.) and other serious diseases that may aggravate the condition and affect the assessment of efficacy.
• • 5. Allergy or intolerance to stem cell preparations or related medicines that need to be used in the infusion process, such as saline preparations and hormone preparations.
• • 6. Pregnant or lactating women.
• • 7. History of stroke disease with sequelae in the last 1 year, NIHSS score ≥ 6.
• • 8. Subarachnoid hemorrhage, primary ventricular hemorrhage, pharmacological hemorrhagic stroke.
• • 9. Unstable vital signs, including combined respiratory abnormalities (respiratory rate \<12 breaths/min or \>24 breaths/min, oxygen saturation ≤90%), hyperthermia (axillary temperature \>39 ℃), blood pressure ≥180/100 mmHg after antihypertensive treatment, blood glucose \>20 mmol/L.
• • 10. Those who are participating in other clinical trials.
• • 11. Previous history of epilepsy or current use of antiepileptic drugs.
• • 12. Unable to accept all laboratory tests and imaging tests designed by the program due to metal implants or pacemakers in the body.
• • 13. Inability to complete the follow-up program as required.
• • 14. Patients or their legal guardians are unwilling to sign the written informed consent.