RecruitingPhase 1Phase 2NCT06361433

Intracerebral Transplantation of Autologous MSC Combined With Scaffold Product for Chronic Intracerebral Hemorrhage

Phase I/II Trial of Intracerebral Transplantation of Autologous Bone Marrow Stromal Cells Combined With Recombinant Peptide Scaffold for Patients With Chronic Intracerebral Hemorrhage

Sponsor

Hokkaido University Hospital

Enrollment

8 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Intracerebral Hemorrhage

Summary

The goal of this clinical trial is to test intracerebral transplantation of stem cell product in patient with chronic intracerebral hemorrhage. The main questions aims to answer are: * The safety of the product * The efficacy of the product

Eligibility

Min Age: 20 YearsMax Age: 70 Years

Inclusion Criteria6

\. Age between 20 and 70 years
\. Clinical diagnosis of intracerebral hemorrhage 12 month or more from onset
\. Hemorrhagic location of unilateral basal ganglia or thalamus
\. Moderate to severe neurological symptoms; mRS 3 or 4, and Brunnstrom stage Ⅲ or IV
\. No significant neurological impairment before hemorrhage (Pre-hemorrhagic mRS of 0 or 1)
\. Subjects who can give informed consent by its self

Exclusion Criteria17

\. Severe microbleeds found by T2*
\. Hemorrhagic cavity less than 2 mL
\. The hemorrhage is due to arteriovenous malformation, cerebral aneurysm, and Moyamoya disease
\. Subject showing obvious communication between the hemorrhagic cavity and lateral ventricle on MRI
\. Subject showing severe lower extremity contracture (Maximum knee extension less than -15 degrees, Maximum ankle flexion less than 0 degree)
\. Subject's body weight less than 45 kg for male and 40kg for female
\. Anaemia (Hg < 10·0 g/dL)
\. Thrombocytopaenia (platelet count < 100,000/mm3)
\. Severe heart disease (ischaemic heart disease, heart failure)
\. Uncontrolled hypertension, despite antihypertensive therapy
\. Carriers of infectious disease: syphilis, HBV, HCV, HIV-1/HIV-2, HTLV-1, parvovirus B19
\. Pregnant or lactating or expecting to become pregnant during the study
\. History of malignancy
\. Systemic organ failure ALT ≤ 3·0× upper limit of normal Total bilirubin ≤ 1·5× upper limit of normal Serum creatinine ≤ 1·5× upper limit of normal
\. Known serious allergy to any agents used in the study
\. Contraindication for magnetic resonance imaging
\. Any condition that in the judgement of the investigator would place the patient at undue risk

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Interventions

DRUGHUFF-01

autologous MSC combined with scaffold

Locations(1)

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

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NCT06361433

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