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Intracerebral HemorrhagePhase 1/2RAINBOW-HxNCT06361433

Intracerebral Transplantation of Autologous MSC Combined With Scaffold Product for Chronic Intracerebral Hemorrhage

A Phase 1/2 study testing HUFF-01 in people with Intracerebral Hemorrhage, run by Hokkaido University Hospital at 1 site in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to test intracerebral transplantation of stem cell product in patient with chronic intracerebral hemorrhage. The main questions aims to answer are: The safety of the product The efficacy of the product Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Intracerebral Hemorrhage
What is being tested?
HUFF-01
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteJapan
Study dates
1 Dec 2023to Sep 2027
Phase
Phase 1/2
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

  • 1. Age between 20 and 70 years
  • 2. Clinical diagnosis of intracerebral hemorrhage 12 month or more from onset
  • 3. Hemorrhagic location of unilateral basal ganglia or thalamus
  • 4. Moderate to severe neurological symptoms; mRS 3 or 4, and Brunnstrom stage Ⅲ or IV
  • 5. No significant neurological impairment before hemorrhage (Pre-hemorrhagic mRS of 0 or 1)
  • 6. Subjects who can give informed consent by its self

Who cannot join

  • 1. Severe microbleeds found by T2*
  • 2. Hemorrhagic cavity less than 2 mL
  • 3. The hemorrhage is due to arteriovenous malformation, cerebral aneurysm, and Moyamoya disease
  • 4. Subject showing obvious communication between the hemorrhagic cavity and lateral ventricle on MRI
  • 5. Subject showing severe lower extremity contracture (Maximum knee extension less than -15 degrees, Maximum ankle flexion less than 0 degree)
  • 6. Subject's body weight less than 45 kg for male and 40kg for female
Show all 17Show fewer
  • 7. Anaemia (Hg < 10·0 g/dL)
  • 8. Thrombocytopaenia (platelet count < 100,000/mm3)
  • 9. Severe heart disease (ischaemic heart disease, heart failure)
  • 10. Uncontrolled hypertension, despite antihypertensive therapy
  • 11. Carriers of infectious disease: syphilis, HBV, HCV, HIV-1/HIV-2, HTLV-1, parvovirus B19
  • 12. Pregnant or lactating or expecting to become pregnant during the study
  • 13. History of malignancy
  • 14. 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
  • 15. Known serious allergy to any agents used in the study
  • 16. Contraindication for magnetic resonance imaging
  • 17. 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.

Japan1 site

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 0608638

Other trials in Japan

About this study

Official title: Phase I/II Trial of Intracerebral Transplantation of Autologous Bone Marrow Stromal Cells Combined With Recombinant Peptide Scaffold for Patients With Chronic Intracerebral Hemorrhage

The goal of this clinical trial is to test intracerebral transplantation of stem cell product in patient with chronic intracerebral hemorrhage. The main questions aims to answer are:

  • The safety of the product
  • The efficacy of the product
Read the detailed description

Introduction:

Intracerebral hemorrhage stands as a leading global cause of death and disability, posing a significant challenge with limited treatment options, especially for chronic patients. Recent advances of stem cell therapies have opened new avenues for therapeutic potential. The investigators' previous preclinical research has demonstrated that intracerebral transplantation of bone marrow stromal cells (BMSCs) combined with a recombinant human collagen type I scaffold enables higher cell survival and engraftment, holds promising potential. The investigators present the protocol for a novel clinical trial, named "Research on Advanced Intervention using Novel Bone Marrow Stem Cells for Chronic Intracerebral Hemorrhage" (RAINBOW-Hx).

Methods and Analysis:

RAINBOW-Hx is a phase I/II, open-label, uncontrolled study with the primary objective of assessing the safety and efficacy of intracerebral transplantation of autologous BMSCs combined with the scaffold (HUFF-01) in patients with chronic intracerebral hemorrhage. Eight patients, experiencing moderate to severe neurological deficits for 12 months or longer, will be enrolled. The hemorrhage location will be limited to the basal ganglia and thalamus. Approximately 50 mL of bone marrow will be extracted from the iliac bone of each patient, and BMSCs will be cultured using autologous platelet lysate. Three days before transplantation, BMSCs will be combined with the scaffold to generate HUFF-01. Each patient will receive a 50,000 HUFF-01 dose, containing approximately 50 million BMSCs, through stereotactic transplantation into the hemorrhagic cavity. Neurological assessments, magnetic resonance imaging, 18F-fluorodeoxyglucose positron emission tomography, and 123I-Iomazenil single-photon emission computed tomography will be performed for one year after administration.

Being tested
HUFF-01
Keywords
Mesenchymal stromal cell, scaffold, chronic, intracerebral hemorrhage, intraparenchymal transplantation
Medical subject headings
Cerebral Hemorrhage, Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HUFF-01Drug

    autologous MSC combined with scaffold

Study groups in NCT06361433
Study groupRoleWhat they receive
Cell product transplantationExperimentalAutologous MSC with scaffold containing approximately 5 x 10^7 MSC cells.
Receives: Drug: HUFF-01

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Listing unexpected CTCAE grade changes in physiological (physical examination/blood test) and Radiographical (MRI/CT) examination

    Measured: one year

Secondary outcomes (7)

  1. Change in mRS examination

    Percentage of the patients number who showed improvement of mRS (0-6, higher score means worse outcome) of more than 1 point

    Measured: One year

  2. Change in NIHSS examination

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

    Measured: One year

  3. Change in FIM examination

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

    Measured: One year

  4. Change in Fugl-Myer examination

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

    Measured: One year

  5. Change in Barthal index examination

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

    Measured: One year

  6. Change in FDG-PET examination

    Mean improvement of FDG-PET set for ipsilateral motor cortex

    Measured: One year

  7. 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.

  1. First posted11 Apr 2024
  2. Study start1 Dec 2023
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06361433
Sponsor's protocol ID
R5-11
Acronym
RAINBOW-Hx
Status last verified
Oct 2026
First submitted
25 Jan 2024
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HUFF-01 in people with Intracerebral Hemorrhage, 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 6 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06361433.

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 15 Oct 2026.

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