Stem cell therapy for chronic stroke recovery

Intracerebral Autologous Mesenchymal Stem Cell Transplantation Therapy for Patients with Ischemic Stroke in Chronic Phase: Phase 2a Clinical Trial

This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (estimated)
• Ages: 20 Years to 70 Years
• Sex: All
• Sponsor: Hokkaido University Hospital (Academic / other)
• Locations: 1 site (Sapporo, Hokkaido)
• Trial ID: NCT06752720 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of autologous mesenchymal stem cell transplantation (HUNS001-01) in promoting neurological recovery in patients suffering from chronic ischemic stroke with moderate to severe symptoms. Participants will undergo a series of procedures including screening, harvesting of bone marrow and platelet concentrates, and intracerebral transplantation surgery, followed by rehabilitation and follow-up assessments for one year. The primary goals are to determine if this therapy can improve disability scores and to assess safety over the study period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 to 70 who have experienced an ischemic stroke 6 months to 5 years prior and exhibit moderate to severe neurological symptoms.

Not a fit: Patients with severe contractures, significant pre-stroke neurological impairment, or severe systemic health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly enhance recovery and quality of life for chronic stroke patients.

How similar studies have performed: While stem cell therapies for stroke are being explored, this specific approach using autologous mesenchymal stem cells is relatively novel and has not been extensively tested in prior studies.

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

Where this trial is running

Sapporo, Hokkaido

• Hokkaido University Hospital — Sapporo, Hokkaido, Japan (Recruiting)

Study contacts

• Study coordinator: Kota Kurisu, M.D., Ph.D.

Conditions Stroke; Stroke, Ischemic; Sequelae; stem cell therapy; mesenchymal stem cell; ischemic stroke; chronic