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NCT Number: NCT06752720

Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients

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)

Recruiting

Interested in participating?

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hokkaido University Hospital

Sapporo, Hokkaido, 0608638, Japan

Location status: Recruiting

Location contact

Kota Kurisu, M.D., Ph.D.

CONTACT

[email protected]

81-11-706-1061 ext. 5987

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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"
  • Any condition that in the judgement of the investigator would place the patient at undue risk

Treatment and study plan

Stem cell Transplantation

Drug

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 outcomes

  1. Efficacy of HUNS001-01 administration

    Time frame: one year

    The frequency of the improvement in mRS of disability by 1 or more from baseline

Secondary outcomes

  1. Safety of HUNS001-01 administration

    Time frame: one year

    frequency of Adverse Event

  2. Change in NIHSS examination

    Time frame: one year

    Mean improvement of NIHSS (0-42, higher score means worse outcome)

  3. Change in FIM examination

    Time frame: one year

    Mean improvement of FIM (18-126, higher score means better outcome)

  4. Change in Fugl-Myer examination

    Time frame: one year

    Mean improvement of Fugl-Myer (0-226, higher score means better outcome)

  5. Change in Barthal index examination

    Time frame: one year

    Mean improvement of Barthal index (0-100, higher score means better outcome)

  6. Change in FDG-PET examination

    Time frame: one year

    Mean improvement of FDG-PET set for ipsilateral motor cortex

  7. Change in IMZ-SPECT examination

    Time frame: one year

    Mean improvement of IMZ-SPECT set for ipsilateral motor cortex

Study contacts

Contact information is provided by the study sponsor or research team.

Kota Kurisu, M.D., Ph.D.

CONTACT

[email protected]

+81-11-706-1161 ext. 5987

Sponsors and collaborators

Lead sponsor

Hokkaido University Hospital

Other

Collaborators

  • RAINBOW Inc.

Registry information

Official study title

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

Acronym: RAINBOW-2a

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Dec 31, 2024
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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