Skip to content

RAINBOW-Hx trial

Phase I/II trial of Intracerebral Transplantation of Autologous Bone Marrow Stromal Cells Combined with Recombinant Peptide Scaffold for Patients with Chronic Intracerebral Hemorrhage

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2013230053
Enrollment
8
Registered
2023-12-06
Start date
2024-01-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral hemorrhage Chronic, hemorrhage, brain

Interventions

Intracerebral transplantaion of HUFF-01

Sponsors

Kawabori Masahito
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 1. Severe microbleeds 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

Design outcomes

Primary

MeasureTime frame
Safety of HUFF-01 up to 1 year after transplantation

Secondary

MeasureTime frame
Safety of HUFF-01 up to 1 week after transplantation Neurological assessments Radiographycal assessments

Contacts

Public ContactMasahito Kawabori

Hokkaido University Hospital

masahitokawabori@yahoo.co.jp+81-11-716-1161

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026