Stem Cell Therapy for Intracerebral Hemorrhage
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTang Zhouping
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-65 years old, gender is not limited.
Clinically confirmed intracerebral hemorrhage during the subacute period (3 days-10 days after onset).
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)).
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.
Disqualifiers
Brain midline deviation >10 mm or brain hernia formation.
Patients who have undergone or intend to undergo surgical treatment to remove hematoma.
Secondary intracerebral hemorrhage caused by traumatic brain injury, arteriovenous malformation, intracranial aneurysm, coagulation disorders, hemorrhagic transformation after cerebral infarction, or tumors.
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Device: Phase Ⅰ Dose Level 1
Biological/VaccinePatients in the first dose level will receive a cell dose of 1×10\^6 cells/kg.
Device: Phase Ⅰ Dose Level 2
Biological/VaccinePatients in the second dose level will receive a cell dose of 2×10\^6 cells/kg.
Device: Phase Ⅰ Dose Level 3
Biological/VaccinePatients 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/VaccineThis group subjects received the MTD obtained in phase I.
Device: Phase II lower than the MTD in Phase I
Biological/VaccineThis group subjects received a dose lower than the MTD
Treatment groups
39 Participants
are divided into 3 treatment groupsGroup A: PhaseⅠclinical trial: 3+3 dose-escalation designExperimental treatment 3 interventions
Group B: Phase Ⅱ clinical trial: MTD groupExperimental treatment 1 intervention
Group C: Phase Ⅱ clinical trial: lower than the MTD groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of serious adverse events
The incidence of serious adverse events (SAEs, such as recurrent bleeding, progressive stroke, brain death, respiratory failure, renal failure, circulatory failure, secondary epilepsy, sepsis, deep vein thrombosis, etc.) and treatment-related adverse events (TEAEs, such as fever or allergies after intravenous infusion of human umbilical cord mesenchymal stem cells(UC-MSCs)) occurring within 6 months of receiving UC-MSCs therapy.
Time frame
Up to 6 months post-transplantation2
Hematoma volume
Volume of intracerebral hemorrhage measured in cubic centimeters (cm³) as determined by quantitative analysis of head computed tomography scans.
Time frame
Baseline and 7 days, 2 weeks, 1 month, 6 months post-transplantation for phase I; Baseline and 7 days, 2 weeks, 3 weeks, 1 month, 6 months post-transplantation for phase Ⅱ.3
Peri-hematomal edema volume
Volume of edema surrounding the hematoma measured in cubic centimeters (cm³) as determined by quantitative analysis of head magnetic resonance imaging scans.
Time frame
Baseline and 7 days, 2 weeks, 1 month, 6 months post-transplantation for phase I; Baseline and 7 days, 2 weeks, 3 weeks, 1 month, 6 months post-transplantation for phase Ⅱ.4
National Institutes of Health Stroke Scale (NIHSS) score
The NIHSS is a neurological examination scale that provides a quantitative measure of stroke-related neurologic deficit. Scores range from 0 to 42 points, with higher scores indicating more severe neurological impairment.
Time frame
Baseline and 7 days, 2 weeks, 3 weeks, 1 month, 3 months, 6 months post-transplantation for phase Ⅱ.Secondary outcomes
1
Incidence of adverse events
The incidence of all non-serious adverse events occurring from infusion date through end of follow-up, including stress ulcers, pneumonia, injection site infections, and fever.
Time frame
Up to 6 months post-transplantation2
Pulmonary Embolism
Binary assessment (present/absent) of pulmonary embolism based on chest computed tomography with contrast enhancement.
Time frame
Baseline and 7 days, 2 weeks, 1 month, 6 months post-transplantation for phase I; Baseline and 3 weeks, 6 months post-transplantation for phase Ⅱ.3
Electrocardiogram ST Segment Deviation
Measurement of ST segment elevation or depression in millimeters from baseline. ST elevation ≥1mm in two or more contiguous leads or ST depression ≥0.5mm will be classified as abnormal.
Time frame
Baseline and 1 day, 2 days, 7 days, 2 weeks, 3 weeks, 1 month, 3 months, 6 months post-transplantation for phase I.; Baseline and 7 days, 2 weeks, 3 weeks, 1 month, 6 months post-transplantation for phase Ⅱ.4
Electrocardiogram Pathological Q Waves
Assessment for presence of pathological Q waves, defined as Q waves ≥40ms in duration or ≥25% of the height of the following R wave in at least two contiguous leads.
Time frame
Baseline and 1 day, 2 days, 7 days, 2 weeks, 3 weeks, 1 month, 3 months, 6 months post-transplantation for phase I.; Baseline and 7 days, 2 weeks, 3 weeks, 1 month, 6 months post-transplantation for phase Ⅱ.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tang Zhouping
Lead sponsor
Tongji Hospital
Sponsor institution
Wuhan Hamilton Biotechnology Co., Ltd
Collaborator
Source ClinicalTrials.gov
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