NCT06361433Active, not recruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 8 (estimated)
- First submitted
- 25 Jan 2024
- Start date
- 1 Dec 2023
- Primary completion date
- Sept 2027
- Lead sponsor
- Hokkaido University Hospital
- NCT number
- NCT06361433
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 8
- From 1 Dec 2023 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 3\. The hemorrhage is due to arteriovenous malformation, cerebral aneurysm, and Moyamoya disease
- 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
- 13\. History of malignancy
- 15\. Known serious allergy to any agents used in the study
- 17\. Any condition that in the judgement of the investigator would place the patient at undue risk
Lab values
- 7\. Anaemia (Hg \< 10·0 g/dL)
- 8\. Thrombocytopaenia (platelet count \< 100,000/mm3)
- 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
Other
- 1\. Severe microbleeds found by T2\*
- 2\. Hemorrhagic cavity less than 2 mL
- 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
- 12\. Pregnant or lactating or expecting to become pregnant during the study
- 16\. Contraindication for magnetic resonance imaging
Who the study is looking for
- 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
Age in the registry: 20 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hokkaido University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.