Clinical Trials in Japan / NCT06361433
Active, not recruiting
Phase 1/2
Intracerebral Transplantation of Autologous MSC Combined With Scaffold Product for Chronic Intracerebral Hemorrhage
NCT06361433 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Intracerebral Hemorrhage
Investigational drug(s) / intervention(s)
HUFF-01
HUFF-01: autologous MSC combined with scaffold
Study 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
Inclusion Criteria:
* 1\. Age between 20 and 70 years
* 2\. Clinical diagnosis of intracerebral hemorrhage 12 month or more from onset
* 3\. Hemorrhagic location of unilateral basal ganglia or thalamus
* 4\. Moderate to severe neurological symptoms; mRS 3 or 4, and Brunnstrom stage Ⅲ or IV
* 5\. No significant neurological impairment before hemorrhage (Pre-hemorrhagic mRS of 0 or 1)
* 6\. Subjects who can give informed consent by its self
Exclusion Criteria:
* 1\. Severe microbleeds found by T2\*
* 2\. Hemorrhagic cavity less than 2 mL
* 3\. The hemorrhage is due to arteriovenous malformation, cerebral aneurysm, and Moyamoya disease
* 4\. Subject showing obvious communication between the hemorrhagic cavity and lateral ventricle on MRI
* 5\. Subject showing severe lower extremity contracture (Maximum knee extension less than -15 degrees, Maximum ankle flexion less than 0 degree)
* 6\. Subject's body weight less than 45 kg for male and 40kg for female
* 7\. Anaemia (Hg \< 10·0 g/dL)
* 8\. Thrombocytopaenia (platelet count \< 100,000/mm3)
* 9\. Severe heart disease (ischaemic heart disease, heart failure)
* 10\. Uncontrolled hypertension, despite antihypertensive therapy
* 11\. Carriers of infectious disease: syphilis, HBV, HCV, HIV-1/HIV-2, HTLV-1, parvovirus B19
* 12\. Pregnant or lactating or expecting to become pregnant during the study
* 13\. History of malignancy
* 14\. 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
* 15\. Known serious allergy to any agents used in the study
* 16\. Contraindication for magnetic resonance imaging
* 17\. Any condition that in the judgement of the investigator would place the patient at undue risk
Primary outcome measure(s)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 — one year
Listing unexpected CTCAE grade changes in physiological (physical examination/blood test) and Radiographical (MRI/CT) examination
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Hokkaido University Hospital | Sapporo | Hokkaido |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06361433 on ClinicalTrials.gov ↗ ← All trials in Japan