Intracerebral HemorrhagePhase 1/2NCT06862388
Stem Cell Therapy for Intracerebral Hemorrhage
A Phase 1/2 study testing Device: Phase Ⅰ Dose Level 1, Device: Phase Ⅰ Dose Level 2 and Device: Phase Ⅰ Dose Level 3 in people with Intracerebral Hemorrhage and Mesenchymal Stem Cell, run by Tang Zhouping at 1 site in China.
Trial summary
Intracerebral hemorrhage (ICH) is a common condition with high morbidity, mortality, and disability. The current treatments for ICH primarily include surgical and pharmacological interventions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intracerebral Hemorrhage, Mesenchymal Stem Cell
- What is being tested?
- Device: Phase Ⅰ Dose Level 1, Device: Phase Ⅰ Dose Level 2 and Device: Phase Ⅰ Dose Level 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2025to 31 Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- National Institutes of Health Stroke Scale score (NIHSS) ≥5 and ≤20.
- Pre-onset modified Ranking Scale score (mRS) ≤1.
- Glasgow Coma Score (GCS) ≥9 points and ≥3 points on a single item.
- Good compliance, signed informed consent by the person and/or legal guardian and able to receive follow-up visits at the specified time.
Who cannot join
- 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.
- 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.
- Pregnant or lactating women.
Show all 14Show fewer
- History of stroke disease with sequelae in the last 1 year, NIHSS score ≥ 6.
- Subarachnoid hemorrhage, primary ventricular hemorrhage, pharmacological hemorrhagic stroke.
- 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.
- Those who are participating in other clinical trials.
- Previous history of epilepsy or current use of antiepileptic drugs.
- Unable to accept all laboratory tests and imaging tests designed by the program due to metal implants or pacemakers in the body.
- Inability to complete the follow-up program as required.
- Patients or their legal guardians are unwilling to sign the written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Zhouping Tang, +86-13476057613, ddjtzp@163.com
About this study
Official title: Clinical Research on Umbilical Cord Mesenchymal Stem Cells Therapy for Patients With Subacute Intracerebral Hemorrhage
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.
Read the detailed description
This clinical trial is divided into two phases: Phase I and Phase II. The Phase I clinical trial is a single-center, open-label, dose-escalation study. It follows a 3+3 dose-escalation design and includes the following phases: screening/baseline phase, stem cell treatment phase, safety and tolerability observation phase, and follow-up phase, with a total of 10 visits. The primary focus of Phase I is to assess the safety of stem cell treatment. There are three dose groups, with at least 3 subjects in each group. Each subject will receive a cell dose of 1×10^6 cells/kg, 2×10^6 cells/kg, or 4×10^6 cells/kg. Phase I will enroll patients with subacute intracerebral hemorrhage who meet all inclusion and exclusion criteria. In line with the 3+3 dose-escalation design, human umbilical cord mesenchymal stem cells (UC-MSCs) will be intravenously administered at the designated doses at specific time points. The study will then observe both the primary and secondary safety endpoints following transplantation.
The Phase II clinical trial is also a single-center, open-label study. It is an exploratory efficacy study, consisting of a screening/baseline phase, stem cell treatment phase, and follow-up phase, with 8 visits in total. The primary objective of Phase II is to evaluate the safety and efficacy of UC-MSCs in the treatment of subacute intracerebral hemorrhage. The Phase II trial will consist of two groups, each with 15 subjects, for a total of 30 participants. The specific number of cells to be transplanted will be determined based on the findings from Phase I. UC-MSCs or saline will be intravenously infused into the subjects at designated time points, and visits will be scheduled according to the study plan. The primary safety and efficacy endpoints, as well as secondary endpoints, will be closely monitored after transplantation.
- Conditions
- Intracerebral Hemorrhage, Mesenchymal Stem Cell
- Being tested
- Device: Phase Ⅰ Dose Level 1, Device: Phase Ⅰ Dose Level 2, Device: Phase Ⅰ Dose Level 3, Device: Phase II MTD in Phase I, Device: Phase II lower than the MTD in Phase I
- Keywords
- Intracerebral hemorrhage, Human umbilical cord mesenchymal stem cells, Stem cell therapy, Inflammation, Neural repair
- Medical subject headings
- Cerebral Hemorrhage, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Phase Ⅰ Dose Level 1Biological
Patients in the first dose level will receive a cell dose of 1×10^6 cells/kg.
Device: Phase Ⅰ Dose Level 2Biological
Patients in the second dose level will receive a cell dose of 2×10^6 cells/kg.
Device: Phase Ⅰ Dose Level 3Biological
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 IBiological
This group subjects received the MTD obtained in phase I.
Device: Phase II lower than the MTD in Phase IBiological
This group subjects received a dose lower than the MTD
| Study group | Role | What they receive |
|---|---|---|
| PhaseⅠclinical trial: 3+3 dose-escalation design | Experimental | The Phase I clinical trial is a 3+3 dose-escalation trial, with three dose groups, each including at least 3 subjects. The trial begins with the low-dose group. If the dose-limiting toxicity (DLT) assessment during the observation period meets the criteria of the 3+3 dose-escalation design, enrollment will proceed to the next higher dose group. Each subject will receive one dose of human umbilical cord mesenchymal stem cells (UC-MSCs) therapy, in addition to the standard treatment for intracerebral hemorrhage. Receives: Biological: Device: Phase Ⅰ Dose Level 1; Biological: Device: Phase Ⅰ Dose Level 2; Biological: Device: Phase Ⅰ Dose Level 3 |
| Phase Ⅱ clinical trial: MTD group | Experimental | The Phase II clinical trial included two groups. The dose of UC-MSCs received in each group patients will be determined based on the phase I results. One of the two groups subjects received the MTD obtained in phase I, and the other group subjects received a dose lower than the MTD. Each subject in the Phase II clinical trial received three dose of stem cell therapies after enrollment.The second therapy is 7 days after the first therapy, and the third therapy is 7 days after the second therapy. Receives: Biological: Device: Phase II MTD in Phase I |
| Phase Ⅱ clinical trial: lower than the MTD group | Experimental | The Phase II clinical trial included two groups. The dose of UC-MSCs received in each group patients will be determined based on the phase I results. One of the two groups subjects received the MTD obtained in phase I, and the other group subjects received a dose lower than the MTD. Each subject in the Phase II clinical trial received three dose of stem cell therapies after enrollment.The second therapy is 7 days after the first therapy, and the third therapy is 7 days after the second therapy. Receives: Biological: Device: Phase II lower than the MTD in Phase I |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months post-transplantation
Hematoma volume
Volume of intracerebral hemorrhage measured in cubic centimeters (cm³) as determined by quantitative analysis of head computed tomography scans.
Measured: 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.
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.
Measured: 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.
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.
Measured: Baseline and 7 days, 2 weeks, 3 weeks, 1 month, 3 months, 6 months post-transplantation for phase Ⅱ.
The modified Rankin Scale (mRS) score
The mRS measures the degree of disability or dependence in daily activities among individuals who have suffered a stroke. Scores range from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability.
Measured: Baseline and 7 days, 2 weeks, 3 weeks, 1 month, 3 months, 6 months post-transplantation for phase Ⅱ.
Barthel Index scale score
The Barthel Index assesses functional independence in activities of daily living across 10 items. Total scores range from 0 to 100, with higher scores indicating greater independence in activities of daily living.
Measured: Baseline and 7 days, 2 weeks, 3 weeks, 1 month, 3 months, 6 months post-transplantation for phase Ⅱ.
Secondary outcomes (46)
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.
Measured: Up to 6 months post-transplantation
Pulmonary Embolism
Binary assessment (present/absent) of pulmonary embolism based on chest computed tomography with contrast enhancement.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Electrocardiogram QTc Prolongation
Measurement of corrected QT interval in milliseconds. QTc intervals >450ms in males or >460ms in females will be classified as prolonged, indicating abnormal ventricular repolarization.
Measured: 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.
Electrocardiogram Arrhythmia Assessment
Identification and quantification of cardiac arrhythmias including atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation, and heart blocks. Results will be reported as presence or absence of each arrhythmia type.
Measured: 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.
Mini-Mental State Examination (MMSE) Score
The MMSE is a 30-point questionnaire used to measure cognitive impairment. Scores range from 0 to 30, with higher scores indicating better cognitive function.
Measured: Baseline and 7 days, 2 weeks, 3 weeks, 1 month, 3 months, 6 months post-transplantation for phase Ⅱ.
Montreal Cognitive Assessment (MoCA) Score
The MoCA is a cognitive screening test designed to detect mild cognitive impairment. Scores range from 0 to 30, with higher scores indicating better cognitive function.
Measured: Baseline and 7 days, 2 weeks, 3 weeks, 1 month, 3 months, 6 months post-transplantation for phase Ⅱ.
Hamilton Anxiety Scale (HAMA) Score
The HAMA is a 14-item scale that measures the severity of anxiety symptoms. Scores range from 0 to 56, with higher scores indicating more severe anxiety.
Measured: Baseline and 7 days, 2 weeks, 3 weeks, 1 month, 3 months, 6 months post-transplantation for phase Ⅱ.
Hamilton Depression Scale (HAMD) Score
The HAMD is a 17-item scale that measures the severity of depression symptoms. Scores range from 0 to 52, with higher scores indicating more severe depression.
Measured: Baseline and 7 days, 2 weeks, 3 weeks, 1 month, 3 months, 6 months post-transplantation for phase Ⅱ.
Serum Tumor Necrosis Factor-Alpha (TNF-alpha) Level
Concentration of TNF-alpha in pg/mL measured in serum samples.
Measured: 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.
Serum Interleukin-1 Beta (IL-1beta) Level
Concentration of IL-1beta in pg/mL measured in serum samples.
Measured: 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.
Serum Interleukin-2 Receptor (IL-2R) Level
Concentration of IL-2R in pg/mL measured in serum samples.
Measured: 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.
Serum Interleukin-6 (IL-6) Level
Concentration of IL-6 in pg/mL measured in serum samples.
Measured: 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.
Serum Interleukin-8 (IL-8) Level
Concentration of IL-8 in pg/mL measured in serum samples.
Measured: 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.
Serum Interleukin-10 (IL-10) Level
Concentration of IL-10 in pg/mL measured in serum samples.
Measured: 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.
Hemoglobin Level
Concentration of hemoglobin in blood measured in grams per deciliter (g/dL).
Measured: 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.
White Blood Cell Count
Number of white blood cells per microliter (cells/μL) of blood.
Measured: 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.
Platelet Count
Number of platelets per microliter (cells/μL) of blood.
Measured: 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.
Alanine Aminotransferase (ALT) Level
Concentration of ALT enzyme in international units per liter (IU/L) as a measure of liver function.
Measured: 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.
Aspartate Aminotransferase (AST) Level
Concentration of AST enzyme in international units per liter (IU/L) as a measure of liver function.
Measured: 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.
Blood Urea Nitrogen (BUN) Level
Concentration of BUN in milligrams per deciliter (mg/dL) as a measure of kidney function.
Measured: 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.
Serum Creatinine Level
Concentration of creatinine in milligrams per deciliter (mg/dL) as a measure of kidney function.
Measured: 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.
Urine Protein Level
Concentration of protein in urine measured in milligrams per deciliter (mg/dL).
Measured: 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.
Urine Red Blood Cell Count
Number of red blood cells per high-power field (HPF) in urine microscopy.
Measured: 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.
Fecal Occult Blood Test
Qualitative assessment of occult blood in stool (positive or negative).
Measured: 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.
Serum Sodium Level
Concentration of sodium in serum measured in millimoles per liter (mmol/L).
Measured: 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.
Serum Potassium Level
Concentration of potassium in serum measured in millimoles per liter (mmol/L).
Measured: 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.
Prothrombin Time (PT)
Time required for plasma to clot after addition of tissue factor, measured in seconds.
Measured: 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.
Activated Partial Thromboplastin Time (aPTT)
Time required for plasma to clot after activation of intrinsic pathway, measured in seconds.
Measured: Time required for plasma to clot after activation of intrinsic pathway, measured in seconds.
Total Cholesterol Level
Concentration of total cholesterol in serum measured in milligrams per deciliter (mg/dL).
Measured: 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.
High-Density Lipoprotein (HDL) Cholesterol Level
Concentration of HDL cholesterol in serum measured in milligrams per deciliter (mg/dL).
Measured: 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.
Low-Density Lipoprotein (LDL) Cholesterol Level
Concentration of LDL cholesterol in serum measured in milligrams per deciliter (mg/dL).
Measured: 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.
Fasting Blood Glucose Level
Concentration of glucose in blood after overnight fasting, measured in milligrams per deciliter (mg/dL).
Measured: 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.
CD4+ T Lymphocyte Count
Number of CD4+ T lymphocytes per microliter (cells/μL) of blood as a measure of immune function.
Measured: 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.
CD8+ T Lymphocyte Count
Number of CD8+ T lymphocytes per microliter (cells/μL) of blood as a measure of immune function.
Measured: 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.
CD4+/CD8+ Ratio
Ratio of CD4+ to CD8+ T lymphocytes as a measure of immune system balance.
Measured: 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.
High-Sensitivity C-Reactive Protein (hs-CRP) Level
Concentration of hs-CRP in milligrams per liter (mg/L) as a measure of inflammation.
Measured: 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.
Middle Cerebral Artery Blood Flow Velocity
Mean blood flow velocity in the middle cerebral artery measured in centimeters per second (cm/s) using transcranial Doppler ultrasonography.
Measured: Baseline and 7 days, 2 weeks, 1 month, 6 months post-transplantation for phase I; Baseline and 6 months post-transplantation for phase Ⅱ.
Pulsatility Index
Ratio of the difference between peak systolic and end-diastolic velocities to the mean velocity in cerebral arteries as measured by transcranial Doppler ultrasonography. Higher values indicate increased vascular resistance.
Measured: Baseline and 7 days, 2 weeks, 1 month, 6 months post-transplantation for phase I; Baseline and 6 months post-transplantation for phase Ⅱ.
Carotid Artery Stenosis Percentage
Degree of carotid artery stenosis expressed as percentage reduction in vessel diameter as measured by computed tomography angiography.
Measured: Baseline and 7 days, 2 weeks, 1 month, 6 months post-transplantation for phase I; Baseline and 6 months post-transplantation for phase Ⅱ.
Electroencephalogram Delta Wave Activity
Quantitative measurement of delta wave (0.5-4 Hz) power in microvolts squared (μV²). Increased focal delta activity outside of sleep states indicates abnormal cerebral function.
Measured: 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.
Electroencephalogram Epileptiform Discharges
Quantification of epileptiform discharges (spikes, sharp waves, spike-and-wave complexes) per hour of recording. Presence of ≥1 discharge per hour will be classified as abnormal.
Measured: 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.
Electroencephalogram Background Rhythm Analysis
Assessment of background rhythm frequency in Hertz (Hz) and amplitude in microvolts (μV). Normal adult awake posterior dominant rhythm is 8-13 Hz (alpha rhythm). Slowing below 8 Hz will be classified as abnormal.
Measured: 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.
Corticospinal Tract Integrity
Tractography-based assessment of corticospinal tract integrity expressed as percentage of fibers preserved compared to the unaffected hemisphere. Values range from 0% to 100%, with lower percentages indicating greater tract damage.
Measured: Baseline and 7 days, 2 weeks, 1 month, 6 months post-transplantation for phase I; Baseline and 6 months post-transplantation for phase Ⅱ.
Electroencephalogram Hemispheric Asymmetry
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.
Measured: Quantitative comparison of power spectral density between homologous regions of both cerebral hemispheres. Asymmetry of >50% in any frequency band will be classified as abnormal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start2 Jun 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The clinical trial was divided into phase I and Phase II. The Phase I clinical trial is a Sequential design, and the Phase II clinical trial is a Parallel design.
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang Zhouping
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Hamilton Biotechnology Co., Ltd.
- Responsible party
- Sponsor-investigator, Tang Zhouping, Tongji Hospital
- Investigators
- Zhouping Tang, M.D., Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862388
- Sponsor's protocol ID
- TJ-IRB202502088
- Other IDs
- ChiCTR2500095990
- Status last verified
- Oct 2026
- First submitted
- 3 Nov 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moise KJ Jr. Umbilical cord stem cells. Obstet Gynecol. 2005 Dec;106(6):1393-407. doi: 10.1097/01.AOG.0000188388.84901.e4.
PubMed 16319269Li T, Xia M, Gao Y, Chen Y, Xu Y. Human umbilical cord mesenchymal stem cells: an overview of their potential in cell-based therapy. Expert Opin Biol Ther. 2015;15(9):1293-306. doi: 10.1517/14712598.2015.1051528. Epub 2015 Jun 12.
PubMed 26067213Tsang KS, Ng CPS, Zhu XL, Wong GKC, Lu G, Ahuja AT, Wong KSL, Ng HK, Poon WS. Phase I/II randomized controlled trial of autologous bone marrow-derived mesenchymal stem cell therapy for chronic stroke. World J Stem Cells. 2017 Aug 26;9(8):133-143. doi: 10.4252/wjsc.v9.i8.133.
PubMed 28928910Chang Z, Mao G, Sun L, Ao Q, Gu Y, Liu Y. Cell therapy for cerebral hemorrhage: Five year follow-up report. Exp Ther Med. 2016 Dec;12(6):3535-3540. doi: 10.3892/etm.2016.3811. Epub 2016 Oct 18.
PubMed 28101148Hu Y, Liu N, Zhang P, Pan C, Zhang Y, Tang Y, Deng H, Aimaiti M, Zhang Y, Zhou H, Wu G, Tang Z. Preclinical Studies of Stem Cell Transplantation in Intracerebral Hemorrhage: a Systemic Review and Meta-Analysis. Mol Neurobiol. 2016 Oct;53(8):5269-77. doi: 10.1007/s12035-015-9441-6. Epub 2015 Sep 26.
PubMed 26409481Gao L, Xu W, Li T, Chen J, Shao A, Yan F, Chen G. Stem Cell Therapy: A Promising Therapeutic Method for Intracerebral Hemorrhage. Cell Transplant. 2018 Dec;27(12):1809-1824. doi: 10.1177/0963689718773363. Epub 2018 Jun 5.
PubMed 29871521Gong YH, Hao SL, Wang BC. Mesenchymal Stem Cells Transplantation in Intracerebral Hemorrhage: Application and Challenges. Front Cell Neurosci. 2021 Mar 24;15:653367. doi: 10.3389/fncel.2021.653367. eCollection 2021.
PubMed 33841103Zhou JF, Xiong Y, Kang X, Pan Z, Zhu Q, Goldbrunner R, Stavrinou L, Lin S, Hu W, Zheng F, Stavrinou P. Application of stem cells and exosomes in the treatment of intracerebral hemorrhage: an update. Stem Cell Res Ther. 2022 Jun 28;13(1):281. doi: 10.1186/s13287-022-02965-2.
PubMed 35765072Yang G, Fan X, Mazhar M, Yang S, Xu H, Dechsupa N, Wang L. Mesenchymal Stem Cell Application and Its Therapeutic Mechanisms in Intracerebral Hemorrhage. Front Cell Neurosci. 2022 Jun 13;16:898497. doi: 10.3389/fncel.2022.898497. eCollection 2022.
PubMed 35769327Mishra VK, Shih HH, Parveen F, Lenzen D, Ito E, Chan TF, Ke LY. Identifying the Therapeutic Significance of Mesenchymal Stem Cells. Cells. 2020 May 6;9(5):1145. doi: 10.3390/cells9051145.
PubMed 32384763Ding DC, Shyu WC, Lin SZ. Mesenchymal stem cells. Cell Transplant. 2011;20(1):5-14. doi: 10.3727/096368910X.
PubMed 21396235Hanley DF, Thompson RE, Rosenblum M, Yenokyan G, Lane K, McBee N, Mayo SW, Bistran-Hall AJ, Gandhi D, Mould WA, Ullman N, Ali H, Carhuapoma JR, Kase CS, Lees KR, Dawson J, Wilson A, Betz JF, Sugar EA, Hao Y, Avadhani R, Caron JL, Harrigan MR, Carlson AP, Bulters D, LeDoux D, Huang J, Cobb C, Gupta G, Kitagawa R, Chicoine MR, Patel H, Dodd R, Camarata PJ, Wolfe S, Stadnik A, Money PL, Mitchell P, Sarabia R, Harnof S, Barzo P, Unterberg A, Teitelbaum JS, Wang W, Anderson CS, Mendelow AD, Gregson B, Janis S, Vespa P, Ziai W, Zuccarello M, Awad IA; MISTIE III Investigators. Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial. Lancet. 2019 Mar 9;393(10175):1021-1032. doi: 10.1016/S0140-6736(19)30195-3. Epub 2019 Feb 7.
PubMed 30739747Puy L, Parry-Jones AR, Sandset EC, Dowlatshahi D, Ziai W, Cordonnier C. Intracerebral haemorrhage. Nat Rev Dis Primers. 2023 Mar 16;9(1):14. doi: 10.1038/s41572-023-00424-7.
PubMed 36928219
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on Umbilical Cord Mesenchymal Stem Cells Therapy for Patients With Subacute Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT06862388
- Acronym / sponsor ID
- TJ-IRB202502088
- Conditions
- Intracerebral Hemorrhage, Mesenchymal Stem Cell
- Keywords
- Intracerebral hemorrhage, Human umbilical cord mesenchymal stem cells, Stem cell therapy, Inflammation, Neural repair
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Tang ZhoupingUniversity, hospital or other
- Collaborators
- Wuhan Hamilton Biotechnology Co., Ltd.
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 6 Mar 2025 (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.
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.
Detailed description
This clinical trial is divided into two phases: Phase I and Phase II. The Phase I clinical trial is a single-center, open-label, dose-escalation study. It follows a 3+3 dose-escalation design and includes the following phases: screening/baseline phase, stem cell treatment phase, safety and tolerability observation phase, and follow-up phase, with a total of 10 visits. The primary focus of Phase I is to assess the safety of stem cell treatment. There are three dose groups, with at least 3 subjects in each group. Each subject will receive a cell dose of 1×10^6 cells/kg, 2×10^6 cells/kg, or 4×10^6 cells/kg. Phase I will enroll patients with subacute intracerebral hemorrhage who meet all inclusion and exclusion criteria. In line with the 3+3 dose-escalation design, human umbilical cord mesenchymal stem cells (UC-MSCs) will be intravenously administered at the designated doses at specific time points. The study will then observe both the primary and secondary safety endpoints following transplantation.
The Phase II clinical trial is also a single-center, open-label study. It is an exploratory efficacy study, consisting of a screening/baseline phase, stem cell treatment phase, and follow-up phase, with 8 visits in total. The primary objective of Phase II is to evaluate the safety and efficacy of UC-MSCs in the treatment of subacute intracerebral hemorrhage. The Phase II trial will consist of two groups, each with 15 subjects, for a total of 30 participants. The specific number of cells to be transplanted will be determined based on the findings from Phase I. UC-MSCs or saline will be intravenously infused into the subjects at designated time points, and visits will be scheduled according to the study plan. The primary safety and efficacy endpoints, as well as secondary endpoints, will be closely monitored after transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The clinical trial was divided into phase I and Phase II. The Phase I clinical trial is a Sequential design, and the Phase II clinical trial is a Parallel design.
| Arm | Type | Receives |
|---|---|---|
| PhaseⅠclinical trial: 3+3 dose-escalation design | Experimental | Biological: Device: Phase Ⅰ Dose Level 1, Biological: Device: Phase Ⅰ Dose Level 2, Biological: Device: Phase Ⅰ Dose Level 3The Phase I clinical trial is a 3+3 dose-escalation trial, with three dose groups, each including at least 3 subjects. The trial begins with the low-dose group. If the dose-limiting toxicity (DLT) assessment during the observation period meets the criteria of the 3+3 dose-escalation design, enrollment will proceed to the next higher dose group. Each subject will receive one dose of human umbilical cord mesenchymal stem cells (UC-MSCs) therapy, in addition to the standard treatment for intracerebral hemorrhage. |
| Phase Ⅱ clinical trial: MTD group | Experimental | Biological: Device: Phase II MTD in Phase IThe Phase II clinical trial included two groups. The dose of UC-MSCs received in each group patients will be determined based on the phase I results. One of the two groups subjects received the MTD obtained in phase I, and the other group subjects received a dose lower than the MTD. Each subject in the Phase II clinical trial received three dose of stem cell therapies after enrollment.The second therapy is 7 days after the first therapy, and the third therapy is 7 days after the second therapy. |
| Phase Ⅱ clinical trial: lower than the MTD group | Experimental | Biological: Device: Phase II lower than the MTD in Phase IThe Phase II clinical trial included two groups. The dose of UC-MSCs received in each group patients will be determined based on the phase I results. One of the two groups subjects received the MTD obtained in phase I, and the other group subjects received a dose lower than the MTD. Each subject in the Phase II clinical trial received three dose of stem cell therapies after enrollment.The second therapy is 7 days after the first therapy, and the third therapy is 7 days after the second therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- National Institutes of Health Stroke Scale score (NIHSS) ≥5 and ≤20.
Key exclusion criteria (14 listed)
- 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.
- 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.
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 |
|---|---|---|
| Device: Phase Ⅰ Dose Level 1Patients in the first dose level will receive a cell dose of 1×10^6 cells/kg. | Biological | PhaseⅠclinical trial: 3+3 dose-escalation design |
| Device: Phase Ⅰ Dose Level 2Patients in the second dose level will receive a cell dose of 2×10^6 cells/kg. | Biological | PhaseⅠclinical trial: 3+3 dose-escalation design |
| Device: Phase Ⅰ Dose Level 3Patients 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. | Biological | PhaseⅠclinical trial: 3+3 dose-escalation design |
| Device: Phase II MTD in Phase IThis group subjects received the MTD obtained in phase I. | Biological | Phase Ⅱ clinical trial: MTD group |
| Device: Phase II lower than the MTD in Phase IThis group subjects received a dose lower than the MTD | Biological | Phase Ⅱ clinical trial: lower than the MTD group |
Primary outcome
Incidence of serious adverse events
Time frame: Up to 6 months post-transplantation
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.
Hematoma volume
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.
Volume of intracerebral hemorrhage measured in cubic centimeters (cm³) as determined by quantitative analysis of head computed tomography scans.
Peri-hematomal edema volume
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.
Volume of edema surrounding the hematoma measured in cubic centimeters (cm³) as determined by quantitative analysis of head magnetic resonance imaging scans.
National Institutes of Health Stroke Scale (NIHSS) score
Time frame: Baseline and 7 days, 2 weeks, 3 weeks, 1 month, 3 months, 6 months post-transplantation for phase Ⅱ.
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.
The modified Rankin Scale (mRS) score
Time frame: Baseline and 7 days, 2 weeks, 3 weeks, 1 month, 3 months, 6 months post-transplantation for phase Ⅱ.
The mRS measures the degree of disability or dependence in daily activities among individuals who have suffered a stroke. Scores range from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability.
Barthel Index scale score
Time frame: Baseline and 7 days, 2 weeks, 3 weeks, 1 month, 3 months, 6 months post-transplantation for phase Ⅱ.
The Barthel Index assesses functional independence in activities of daily living across 10 items. Total scores range from 0 to 100, with higher scores indicating greater independence in activities of daily living.
46 secondary outcomes
Incidence of adverse events
Time frame: Up to 6 months post-transplantation
Pulmonary Embolism
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.
Electrocardiogram ST Segment Deviation
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.
Electrocardiogram Pathological Q Waves
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.
Electrocardiogram QTc Prolongation
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.
Electrocardiogram Arrhythmia Assessment
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.
Mini-Mental State Examination (MMSE) Score
Time frame: Baseline and 7 days, 2 weeks, 3 weeks, 1 month, 3 months, 6 months post-transplantation for phase Ⅱ.
Montreal Cognitive Assessment (MoCA) Score
Time frame: Baseline and 7 days, 2 weeks, 3 weeks, 1 month, 3 months, 6 months post-transplantation for phase Ⅱ.
Hamilton Anxiety Scale (HAMA) Score
Time frame: Baseline and 7 days, 2 weeks, 3 weeks, 1 month, 3 months, 6 months post-transplantation for phase Ⅱ.
Hamilton Depression Scale (HAMD) Score
Time frame: Baseline and 7 days, 2 weeks, 3 weeks, 1 month, 3 months, 6 months post-transplantation for phase Ⅱ.
Serum Tumor Necrosis Factor-Alpha (TNF-alpha) Level
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.
Serum Interleukin-1 Beta (IL-1beta) Level
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.
Serum Interleukin-2 Receptor (IL-2R) Level
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.
Serum Interleukin-6 (IL-6) Level
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.
Serum Interleukin-8 (IL-8) Level
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.
Serum Interleukin-10 (IL-10) Level
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.
Hemoglobin Level
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.
White Blood Cell Count
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.
Platelet Count
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.
Alanine Aminotransferase (ALT) Level
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.
Aspartate Aminotransferase (AST) Level
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.
Blood Urea Nitrogen (BUN) Level
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.
Serum Creatinine Level
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.
Urine Protein Level
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.
Urine Red Blood Cell Count
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.
Fecal Occult Blood Test
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.
Serum Sodium Level
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.
Serum Potassium Level
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.
Prothrombin Time (PT)
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.
Activated Partial Thromboplastin Time (aPTT)
Time frame: Time required for plasma to clot after activation of intrinsic pathway, measured in seconds.
Total Cholesterol Level
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.
High-Density Lipoprotein (HDL) Cholesterol Level
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.
Low-Density Lipoprotein (LDL) Cholesterol Level
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.
Fasting Blood Glucose Level
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.
CD4+ T Lymphocyte Count
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.
CD8+ T Lymphocyte Count
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.
CD4+/CD8+ Ratio
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.
High-Sensitivity C-Reactive Protein (hs-CRP) Level
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.
Middle Cerebral Artery Blood Flow Velocity
Time frame: Baseline and 7 days, 2 weeks, 1 month, 6 months post-transplantation for phase I; Baseline and 6 months post-transplantation for phase Ⅱ.
Pulsatility Index
Time frame: Baseline and 7 days, 2 weeks, 1 month, 6 months post-transplantation for phase I; Baseline and 6 months post-transplantation for phase Ⅱ.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Results publication: PubMed 16319269Moise KJ Jr. Umbilical cord stem cells. Obstet Gynecol. 2005 Dec;106(6):1393-407. doi: 10.1097/01.AOG.0000188388.84901.e4.
- Results publication: PubMed 26067213Li T, Xia M, Gao Y, Chen Y, Xu Y. Human umbilical cord mesenchymal stem cells: an overview of their potential in cell-based therapy. Expert Opin Biol Ther. 2015;15(9):1293-306. doi: 10.1517/14712598.2015.1051528. Epub 2015 Jun 12.
- Results publication: PubMed 28928910Tsang KS, Ng CPS, Zhu XL, Wong GKC, Lu G, Ahuja AT, Wong KSL, Ng HK, Poon WS. Phase I/II randomized controlled trial of autologous bone marrow-derived mesenchymal stem cell therapy for chronic stroke. World J Stem Cells. 2017 Aug 26;9(8):133-143. doi: 10.4252/wjsc.v9.i8.133.
- Results publication: PubMed 28101148Chang Z, Mao G, Sun L, Ao Q, Gu Y, Liu Y. Cell therapy for cerebral hemorrhage: Five year follow-up report. Exp Ther Med. 2016 Dec;12(6):3535-3540. doi: 10.3892/etm.2016.3811. Epub 2016 Oct 18.
- Results publication: PubMed 26409481Hu Y, Liu N, Zhang P, Pan C, Zhang Y, Tang Y, Deng H, Aimaiti M, Zhang Y, Zhou H, Wu G, Tang Z. Preclinical Studies of Stem Cell Transplantation in Intracerebral Hemorrhage: a Systemic Review and Meta-Analysis. Mol Neurobiol. 2016 Oct;53(8):5269-77. doi: 10.1007/s12035-015-9441-6. Epub 2015 Sep 26.
- Results publication: PubMed 29871521Gao L, Xu W, Li T, Chen J, Shao A, Yan F, Chen G. Stem Cell Therapy: A Promising Therapeutic Method for Intracerebral Hemorrhage. Cell Transplant. 2018 Dec;27(12):1809-1824. doi: 10.1177/0963689718773363. Epub 2018 Jun 5.
- Results publication: PubMed 33841103Gong YH, Hao SL, Wang BC. Mesenchymal Stem Cells Transplantation in Intracerebral Hemorrhage: Application and Challenges. Front Cell Neurosci. 2021 Mar 24;15:653367. doi: 10.3389/fncel.2021.653367. eCollection 2021.
- Results publication: PubMed 35765072Zhou JF, Xiong Y, Kang X, Pan Z, Zhu Q, Goldbrunner R, Stavrinou L, Lin S, Hu W, Zheng F, Stavrinou P. Application of stem cells and exosomes in the treatment of intracerebral hemorrhage: an update. Stem Cell Res Ther. 2022 Jun 28;13(1):281. doi: 10.1186/s13287-022-02965-2.
- Results publication: PubMed 35769327Yang G, Fan X, Mazhar M, Yang S, Xu H, Dechsupa N, Wang L. Mesenchymal Stem Cell Application and Its Therapeutic Mechanisms in Intracerebral Hemorrhage. Front Cell Neurosci. 2022 Jun 13;16:898497. doi: 10.3389/fncel.2022.898497. eCollection 2022.
- Results publication: PubMed 32384763Mishra VK, Shih HH, Parveen F, Lenzen D, Ito E, Chan TF, Ke LY. Identifying the Therapeutic Significance of Mesenchymal Stem Cells. Cells. 2020 May 6;9(5):1145. doi: 10.3390/cells9051145.
- Results publication: PubMed 21396235Ding DC, Shyu WC, Lin SZ. Mesenchymal stem cells. Cell Transplant. 2011;20(1):5-14. doi: 10.3727/096368910X.
- Results publication: PubMed 30739747Hanley DF, Thompson RE, Rosenblum M, Yenokyan G, Lane K, McBee N, Mayo SW, Bistran-Hall AJ, Gandhi D, Mould WA, Ullman N, Ali H, Carhuapoma JR, Kase CS, Lees KR, Dawson J, Wilson A, Betz JF, Sugar EA, Hao Y, Avadhani R, Caron JL, Harrigan MR, Carlson AP, Bulters D, LeDoux D, Huang J, Cobb C, Gupta G, Kitagawa R, Chicoine MR, Patel H, Dodd R, Camarata PJ, Wolfe S, Stadnik A, Money PL, Mitchell P, Sarabia R, Harnof S, Barzo P, Unterberg A, Teitelbaum JS, Wang W, Anderson CS, Mendelow AD, Gregson B, Janis S, Vespa P, Ziai W, Zuccarello M, Awad IA; MISTIE III Investigators. Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial. Lancet. 2019 Mar 9;393(10175):1021-1032. doi: 10.1016/S0140-6736(19)30195-3. Epub 2019 Feb 7.
- Individual participant dataSharing planned: No
Related trials for Intracerebral Hemorrhage
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Enrolling by invitationEarly Phase 1
Clinical Safety and Efficacy Evaluation of the Blood-cooling and Stasis-removing Formula as an Adjunct to Atorvastatin in the Treatment of Hemorrhagic Moyamoya Disease.
Moyamoya Disease
RecruitingObservational study
INTERACT4 Expansion - Validation Study
Intracerebral Hemorrhage
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring in Adult NSICU Patients
Subarachnoid Hemorrhage, Aneurysmal, Brain Injuries, Traumatic
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia
Expressive Aphasia, Aphasia Following Cerebral Infarction
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.
Zhouping Tang, M.D. principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Device: Phase Ⅰ Dose Level 1, Device: Phase Ⅰ Dose Level 2 and Device: Phase Ⅰ Dose Level 3 in people with Intracerebral Hemorrhage and Mesenchymal Stem Cell, run by Tang Zhouping at 1 site in China.
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 8 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhouping Tang, M.D. (+86-18071423962, ddjtzp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious adverse events (time frame: Up to 6 months post-transplantation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06862388, which also lists 13 linked publications.
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 20 Oct 2026.