Clinical trial NCT06752720: Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients
Official title: Intracerebral Autologous Mesenchymal Stem Cell Transplantation Therapy for Patients with Ischemic Stroke in Chronic Phase: Phase 2a Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Stroke
Stroke, Ischemic
Stroke; Sequelae
Keywords: stem cell therapy
mesenchymal stem cell
ischemic stroke
chronic
Lead sponsor: Hokkaido University Hospital
Sponsor class: OTHER
Collaborators: name: RAINBOW Inc.
First posted: 2024-12-31
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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)


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

Primary outcomes:
measure: Efficacy of HUNS001-01 administration
timeFrame: one year
Secondary outcomes:
measure: Safety of HUNS001-01 administration
timeFrame: one year
measure: Change in NIHSS examination
timeFrame: one year
measure: Change in FIM examination
timeFrame: one year
measure: Change in Fugl-Myer examination
timeFrame: one year
measure: Change in Barthal index examination
timeFrame: one year
measure: Change in FDG-PET examination
timeFrame: one year
measure: Change in IMZ-SPECT examination
timeFrame: one year
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
Study officials:
References: