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Recruiting Phase 2

Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients

NCT06752720 · tracked via the Priya Life Science Japan tracker
Phase
Phase 2
Started
2024-12-01
Last updated
2025-01-24

Condition(s) studied

StrokeStroke, IschemicStroke; Sequelae

Investigational drug(s) / intervention(s)

Stem cell Transplantation

Stem cell Transplantation: Manufactured autologous mescenchymal stem cell (HUNS001-01) in our cell processing center will be injected into the brain, totally 4 x 10\^7 cells, in 2 brain sites.

Study 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

Sex
ALL
Min age
20 Years
Max age
70 Years
Healthy volunteers
No
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 outcome measure(s)

  • Efficacy of HUNS001-01 administration — one year
    The frequency of the improvement in mRS of disability by 1 or more from baseline

Trial sites (1)

FacilityCityRegionStatus
Hokkaido University Hospital Sapporo Hokkaido Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06752720 on ClinicalTrials.gov ↗ ← All trials in Japan