Stem Cell Treatment Placed in the Brain for Lasting Stroke Effects
Tests a patient's own stem cells placed in the brain in adults with stroke.
Plain-language title generated from the registry record
Registry title: Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients
Key facts
- Where
- Sapporo, JapanSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 70 years old?
Source: NCT06752720, who can take part
Where in Japan
- Hokkaido University HospitalSapporo, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hokkaido University Hospital
- Trial code
- NCT06752720
- Record updated
- 24 January 2025
- Original description
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:Read full original descriptionShow less
Intracerebral Autologous Mesenchymal Stem Cell Transplantation Therapy for Patients with Ischemic Stroke in Chronic Phase: Phase 2a Clinical Trial
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)
Inclusion: 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 interanal cerebral artery; Moderate to severe neurological symptoms; mRS 3 or 4, and Brunnstrom stage Ⅲ 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 its self.
Exclusion: Severe heart disease (ischaemic heart disease, heart failure); History of malignancy; Carriers of infectious disease: syphilis, HBV, HCV, HIV-1/HIV-2, HTLV-1, parvovirus B19; Known serious allergy to any agents used in the study; History of seizure within 2 years; Any condition that in the judgement of the investigator would place the patient at undue risk; Anaemia (Hg < 10·0 g/dL); Thrombocytopaenia (platelet count < 100,000/mm3); 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; Subject showing severe lower extremity contracture (Maximum knee extension less than -15 degrees, Maximum ankle flexion less than 0 degree)"; Pregnant or lactating or expecting to become pregnant during the study; Contraindication for magnetic resonance imaging; 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".