Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients

Launched by HOKKAIDO UNIVERSITY HOSPITAL · Dec 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method for people who have experienced a stroke and are still facing significant difficulties, even years after the event. The treatment involves using a type of stem cell therapy called HUNS001-01, which is delivered directly into the brain. Researchers want to find out if this therapy can help improve patients' abilities to function in daily life and if it can be safely done without causing any harm over the course of one year.

To be eligible for the study, participants must be between 20 and 70 years old and have had an ischemic stroke—this is the most common type caused by a blockage in the blood vessels—between six months and five years ago. They should have moderate to severe ongoing symptoms, but they must not have had significant neurological issues before the stroke. If someone is accepted into the trial, they will undergo several steps, including tests to ensure they qualify, a minor surgery to receive the stem cells, and ongoing rehabilitation and follow-up appointments for up to a year. It’s important for potential participants to know that there are specific health conditions that could make them ineligible, so a thorough screening process will be conducted.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • 1. Age between 20 and 70 years
• • 2. Clinical diagnosis of ischemic stroke between 6 months and 5 years ago
• • 3. Ischemic area in the territory of unilateral interanal cerebral artery
• • 4. Moderate to severe neurological symptoms; mRS 3 or 4, and Brunnstrom stage Ⅲ or IV
• • 5. Subjects with a DTI-RAINBOW (R-DTI) value of more than 70% at screening MR imaging
• • 6. No significant neurological impairment before the stroke (Pre-stroke mRS of 0 or 1)
• • 7. Subjects who can give informed consent by its self
• • Exclusion criteria
• • 1. Subject showing severe lower extremity contracture (Maximum knee extension less than -15 degrees, Maximum ankle flexion less than 0 degree)"
• • 2. Anaemia (Hg \< 10·0 g/dL)
• • 3. Thrombocytopaenia (platelet count \< 100,000/mm3)
• • 4. Severe heart disease (ischaemic heart disease, heart failure)
• • 5. Severe 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
• • 6. History of malignancy
• • 7. Carriers of infectious disease: syphilis, HBV, HCV, HIV-1/HIV-2, HTLV-1, parvovirus B19
• • 8. Pregnant or lactating or expecting to become pregnant during the study
• • 9. Known serious allergy to any agents used in the study
• • 10. Contraindication for magnetic resonance imaging
• • 11. History of seizure within 2 years
• • 12. Subject's body weight less than 45 kg for male and 40kg for female "13. Participating in another clinical trial within 90 days, or planning to participate in another clinical trial in the future"
• • 14. Any condition that in the judgement of the investigator would place the patient at undue risk