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Recruiting NCT06752720

Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients

Phase II Interventional Stroke Stroke, Ischemic Stroke; Sequelae

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stem cell Transplantation.
Who it may be relevant to
Registry conditions: Stroke, Stroke, Ischemic, Stroke; Sequelae. Basic parameters: 20 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Intracerebral Autologous Mesenchymal Stem Cell Transplantation Therapy for Patients with Ischemic Stroke in Chronic Phase: Phase 2a Clinical Trial

Overview

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)

Interventions

  • Drug 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.

Primary outcome measures

  • Efficacy of HUNS001-01 administration [Time frame: one year]
Secondary outcome measures (7)
  • Safety of HUNS001-01 administration [Time frame: one year]
  • Change in NIHSS examination [Time frame: one year]
  • Change in FIM examination [Time frame: one year]
  • Change in Fugl-Myer examination [Time frame: one year]
  • Change in Barthal index examination [Time frame: one year]
  • Change in FDG-PET examination [Time frame: one year]
  • Change in IMZ-SPECT examination [Time frame: one year]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • Subject showing severe lower extremity contracture (Maximum knee extension less than -15 degrees, Maximum ankle flexion less than 0 degree)"
  • Anaemia (Hg < 10·0 g/dL)
  • Thrombocytopaenia (platelet count < 100,000/mm3)
  • Severe heart disease (ischaemic heart disease, heart failure)
  • 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
  • History of malignancy
  • Carriers of infectious disease: 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Japan · 1 center
  • Hokkaido University Hospital — Sapporo

Identifiers

NCT: NCT06752720 · R6-8

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗