RAINBOW-Hx trial

JRCT ID: jRCT2013230053

Registered date:06/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: cerebral hemorrhage
• Date of first enrollment: 17/01/2024
• Target sample size: 8
• Study type: Interventional
• Intervention(s): Intracerebral transplantaion of HUFF-01

Outcome(s)

• Primary Outcome: Safety of HUFF-01 up to 1 year after transplantation

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 70age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kawabori Masahito