Stem cell therapy for subacute intracerebral hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial has two parts: Phase I, a small, dose-escalation safety study, and Phase II, an exploratory efficacy study. Phase I uses three dose levels of UC-MSCs (1x10^6, 2x10^6, or 4x10^6 cells per kg) given intravenously to adults 18-65 with subacute ICH, followed by safety observations across multiple visits. Phase II expands to two groups of 15 participants each to evaluate safety and potential efficacy of UC-MSCs at doses determined from Phase I, with eight total study visits. The trial is single-center and open-label in Wuhan, China. Primary focus is safety in Phase I, while Phase II aims to explore efficacy and safety together in a larger cohort.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Zhouping Tang, M.D. — Tongji Hospital
• Study coordinator: Zhouping Tang, M.D.
• Email: ddjtzp@163.com
• Phone: +86-18071423962

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.