Intracerebral hemorrhage
Conditions
Interventions
Phase I clinical trial dose group 1 (low-dose group):Intravenous infusion of low dose human umbilical cord mesenchymal stem cells
Phase I clinical trial dose group 2 (medium dose group):Intravenous infusion of medium dose human umbilical cord mesenchymal stem cells
Phase I clinical trial dose group 3 (medium dose group):Intravenous infusion of midum dose human umbilical cord mesenchymal stem cells
Phase I clinical trial dose group 4 (medium dose group):Intravenous infusions of midum dose human umbilical cord mesenchymal stem cells
Phase I clinical trial dose group 5 (high-dose group):Intravenous infusions of high dose human umbilical cord mesenchymal stem cells
Phase ? clinical trial medium dose group I:Three times intravenous infusions of human umbilical cord mesenchymal stem cells
Phase ? clinical trial medium dose group II:Three times intravenous infusions of human umbilical cord mesenchymal stem cells
Phase ? clinical trial medium dose group III:Three times intravenous infusions of human umbilical cord mesenchymal stem cells
Sponsors
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion 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 cerebral hemorrhage in the basal ganglia (mainly including caudate nucleus, lenticular nucleus, reticular nucleus and amygdala) , the volume of supratentorial hemorrhage was calculated by ABC/2 method (V (cm 3) = a×b×c× 1/2, a was the longest diameter (cm) of the largest hematoma on the level of CT scan, B was the widest diameter (cm) of the hematoma on the level perpendicular to a, C was the thickness (cm) of the hematoma on CT scan); 4. Blood biochemical indexes meet the following conditions:; 1) good coagulation function, international normalized ratio (INR) 50mL/min;4) hemoglobin>90g/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; 4) hemoglobin>90g/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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Barthel Index scale score;The modified Rankin Scale (mRS) score;Serious adverse events and treatment-related adverse events;Head CT examination;Head MRI examination;National Institutes of Health Stroke Scale (NIHSS) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale (HAMA) score;Hamilton Depression Scale (HAMD) score;Adverse event;Clinically significant abnormal vital signs and physical examination;Blood biochemical examination;Routine urine and stool examination;Routine electroencephalogram examination;Transcranial Doppler ultrasound;Mini-Mental State Examination (MMSE) scale score;Montreal Cognitive Assessment (MoCA) scale score; | — |
Countries
China
Contacts
Public ContactZhouping Tang
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Outcome results
None listed