RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

Stem Cell Therapy for Intracerebral Hemorrhage

Sponsor: Tang Zhouping • ClinicalTrials.gov ID: NCT06862388

Registry updated: 2026-10-20

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Description

Intracerebral hemorrhage (ICH) is a common condition with high morbidity, mortality, and disability. The current treatments for ICH primarily include surgical and pharmacological interventions. For large hematomas, surgical options such as craniotomy, debridement, decompression, and minimally invasive hematoma aspiration may be performed. Pharmacological treatments are mainly symptomatic. Despite timely and standardized surgical or pharmacological interventions, many patients with ICH still experience significant sequelae, which severely affect their quality of life and place a substantial burden on both families and society. Currently, there are limited drugs available specifically for the treatment of ICH. In recent years, stem cell therapy has gained attention as a promising treatment for neurological diseases. Human umbilical cord mesenchymal stem cells (UC-MSCs) are multifunctional stem cells with properties such as self-renewal, multidirectional differentiation potential, tissue repair, immunomodulation, and anti-inflammatory effects. Studies have shown that intravenous transplantation of UC-MSCs is safe, and their application in the treatment of ICH can reduce hematoma volume, attenuate cerebral edema and inflammation, and promote the recovery of neurological function. These findings offer a novel therapeutic strategy for ICH. The purpose of this clinical trial is to evaluate the safety and efficacy of UC-MSCs transplantation in patients with subacute intracerebral hemorrhage, and providing a potential new therapeutic approach for this challenging condition.

Interventions

Device: Phase Ⅰ Dose Level 1 (Biological)
Patients in the first dose level will receive a cell dose of 1×10\^6 cells/kg.
Device: Phase Ⅰ Dose Level 2 (Biological)
Patients in the second dose level will receive a cell dose of 2×10\^6 cells/kg.
Device: Phase Ⅰ Dose Level 3 (Biological)
Patients in the third dose level will receive a cell dose of 4×10\^6 cells/kg. Based on these findings, the maximum tolerated dose (MTD) will be determined.
Device: Phase II MTD in Phase I (Biological)
This group subjects received the MTD obtained in phase I.
Device: Phase II lower than the MTD in Phase I (Biological)
This group subjects received a dose lower than the MTD

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.

Conditions

Intracerebral Hemorrhage Mesenchymal Stem Cell

Locations

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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