StrokePhase 2RAINBOW-2aNCT06752720
Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients
A Phase 2 study testing Stem cell Transplantation in people with Stroke and Stroke, Ischemic, run by Hokkaido University Hospital at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Stroke, Stroke, Ischemic, Stroke; Sequelae
- What is being tested?
- Stem cell Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteJapan
- Study dates
- 1 Dec 2024to 30 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Hokkaido University Hospital
Sapporo, Hokkaido, 0608638
Kota Kurisu, M.D., Ph.D., 81-11-706-1061 ext. 5987, kkurisu0912@gmail.com
About this study
Official title: 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?
Read more
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)
- Conditions
- Stroke, Stroke, Ischemic, Stroke; Sequelae
- Being tested
- Stem cell Transplantation
- Keywords
- stem cell therapy, mesenchymal stem cell, ischemic stroke, chronic
- Medical subject headings
- Stroke, Ischemic Stroke, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem cell TransplantationDrug
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 group | Role | What they receive |
|---|---|---|
| Stem cell transplantation | Experimental | Intracerbral transplantation of autologous mescenchymal stem cells (HUNS001-01, 4 x 10^7 MSC cells) Receives: Drug: Stem cell Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of HUNS001-01 administration
The frequency of the improvement in mRS of disability by 1 or more from baseline
Measured: one year
Secondary outcomes (7)
Safety of HUNS001-01 administration
frequency of Adverse Event
Measured: one year
Change in NIHSS examination
Mean improvement of NIHSS (0-42, higher score means worse outcome)
Measured: one year
Change in FIM examination
Mean improvement of FIM (18-126, higher score means better outcome)
Measured: one year
Change in Fugl-Myer examination
Mean improvement of Fugl-Myer (0-226, higher score means better outcome)
Measured: one year
Change in Barthal index examination
Mean improvement of Barthal index (0-100, higher score means better outcome)
Measured: one year
Change in FDG-PET examination
Mean improvement of FDG-PET set for ipsilateral motor cortex
Measured: one year
Change in IMZ-SPECT examination
Mean improvement of IMZ-SPECT set for ipsilateral motor cortex
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start1 Dec 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hokkaido University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RAINBOW Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752720
- Sponsor's protocol ID
- R6-8
- Acronym
- RAINBOW-2a
- Status last verified
- Jan 2025
- First submitted
- 23 Dec 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracerebral Autologous Mesenchymal Stem Cell Transplantation Therapy for Patients with Ischemic Stroke in Chronic Phase: Phase 2a Clinical Trial
- ClinicalTrials.gov ID
- NCT06752720
- Acronym / sponsor ID
- RAINBOW-2a / R6-8
- Conditions
- Stroke, Stroke, Ischemic, Stroke; Sequelae
- Keywords
- stem cell therapy, mesenchymal stem cell, ischemic stroke, chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Hokkaido University HospitalUniversity, hospital or other
- Collaborators
- RAINBOW Inc.
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem cell transplantation | Experimental | Drug: Stem cell TransplantationIntracerbral transplantation of autologous mescenchymal stem cells (HUNS001-01, 4 x 10^7 MSC cells) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stem cell TransplantationManufactured 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. | Drug | Stem cell transplantation |
Primary outcome
Efficacy of HUNS001-01 administration
Time frame: one year
The frequency of the improvement in mRS of disability by 1 or more from baseline
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stem cell Transplantation in people with Stroke and Stroke, Ischemic, run by Hokkaido University Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kota Kurisu, M.D., Ph.D. (+81-11-706-1161 ext. 5987, kkurisu0912@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of HUNS001-01 administration (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.