Transplanting stem cells to treat chronic brain bleeding
Phase I/II Trial of Intracerebral Transplantation of Autologous Bone Marrow Stromal Cells Combined With Recombinant Peptide Scaffold for Patients With Chronic Intracerebral Hemorrhage
This study is testing if transplanting stem cells from patients' own bone marrow can help people with long-term brain bleeding improve their symptoms.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| 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 | NCT06361433 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of transplanting autologous bone marrow-derived mesenchymal stromal cells (BMSCs) combined with a collagen scaffold in patients suffering from chronic intracerebral hemorrhage. The study will enroll eight patients who have experienced moderate to severe neurological deficits for at least 12 months, focusing on those with hemorrhages located in the basal ganglia or thalamus. Bone marrow will be extracted from each participant, and the BMSCs will be cultured and combined with the scaffold prior to transplantation. The trial is designed as a phase I/II, open-label, uncontrolled study to gather preliminary data on this innovative treatment approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 70 with a clinical diagnosis of intracerebral hemorrhage for 12 months or longer and moderate to severe neurological symptoms.
Not a fit: Patients with severe microbleeds, specific hemorrhagic conditions, or significant pre-existing neurological impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve neurological function and quality of life for patients with chronic intracerebral hemorrhage.
How similar studies have performed: While the approach of using stem cells for intracerebral hemorrhage is novel, previous studies have shown promise in related areas of stem cell therapy.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sapporo, Hokkaido
- Hokkaido University Hospital — Sapporo, Hokkaido, Japan (Recruiting)
Study contacts
- Study coordinator: Masahito Kawabori, MD, PHD
- Email: masahitokawabori@yahoo.co.jp
- Phone: +81117065987
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.