Actively Recruiting
Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients
Led by Hokkaido University Hospital · Updated on 2025-01-24
8
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
H
Hokkaido University Hospital
Lead Sponsor
R
RAINBOW Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate if autologous mesenchymal stem cell (HUNS001-01) transplantation therapy can provide neurological recovery in patients with chronic stage of stroke resulting in moderate to severe neurological sequelae. The main questions it aims to answer are: Can HUNS001-01 intracerebral transplantation demonstrate improvement in the mRS of disability for 1 year after intervention? Can HUNS001-01 intracerebral transplantation can be performed without any adverse events for 1 year after intervention? Participants will receive the below interventions. * Screening for the eligibility to enroll the clinical trial (interview, blood test, imaging) * Harvest of platelet concentrates (PC) * Harvest of bone marrows (BM) * Receive intracerebral transplantation surgery of HUNS001-01 * Post-operative rehabilitation * Follow-up studies (until 1 year or termination of the trial)
CONDITIONS
Official Title
Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 20 and 70 years
- Clinical diagnosis of ischemic stroke between 6 months and 5 years ago
- Ischemic area in the territory of unilateral internal cerebral artery
- Moderate to severe neurological symptoms; mRS 3 or 4, and Brunnstrom stage II or IV
- Subjects with a DTI-RAINBOW (R-DTI) value of more than 70% at screening MR imaging
- No significant neurological impairment before the stroke (Pre-stroke mRS of 0 or 1)
- Subjects who can give informed consent by themselves
You will not qualify if you...
- Severe lower extremity contracture (Maximum knee extension less than -15 degrees, Maximum ankle flexion less than 0 degree)
- Anaemia (Hemoglobin less than 10.0 g/dL)
- Thrombocytopaenia (platelet count less than 100,000/mm3)
- Severe heart disease (ischemic heart disease, heart failure)
- Severe systemic organ failure: ALT less than 3.7 times upper limit of normal, Total bilirubin less than 1.75 times upper limit of normal, Serum creatinine less than 1.75 times upper limit of normal
- History of malignancy
- Carriers of infectious diseases: syphilis, HBV, HCV, HIV-1/HIV-2, HTLV-1, parvovirus B19
- Pregnant or lactating or expecting to become pregnant during the study
- Known serious allergy to any agents used in the study
- Contraindication for magnetic resonance imaging
- History of seizure within 2 years
- Body weight less than 45 kg for males and less than 40 kg for females
- Participating in another clinical trial within 90 days, or planning to participate in another clinical trial in the future
- Any condition that in the judgement of the investigator would place the patient at undue risk
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 0608638
Actively Recruiting
Research Team
K
Kota Kurisu, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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