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

NCT06361433 | Recruiting Phase 1 DMC

• 1 other identifier: R5-11
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Intracerebral Hemorrhage

Keywords

Mesenchymal stromal cell; scaffold; chronic; intracerebral hemorrhage; intraparenchymal transplantation

Outcome Measures

Primary Outcomes (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

  one year

Secondary Outcomes (7)

• Change in mRS examination

  One year

• Change in NIHSS examination

  One year

• Change in FIM examination

  One year

• Change in Fugl-Myer examination

  One year

• Change in Barthal index examination

  One year

Study Arms (1)

Cell product transplantation

EXPERIMENTAL

Autologous MSC with scaffold containing approximately 5 x 10\^7 MSC cells.

Drug: HUFF-01

Interventions

HUFF-01 DRUG

autologous MSC combined with scaffold

Cell product transplantation

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Severe microbleeds found by T2\*
• \. Hemorrhagic cavity less than 2 mL
• \. The hemorrhage is due to arteriovenous malformation, cerebral aneurysm, and Moyamoya disease
• \. Subject showing obvious communication between the hemorrhagic cavity and lateral ventricle on MRI
• \. Subject showing severe lower extremity contracture (Maximum knee extension less than -15 degrees, Maximum ankle flexion less than 0 degree)
• \. Subject's body weight less than 45 kg for male and 40kg for female
• \. Anaemia (Hg \< 10·0 g/dL)
• \. Thrombocytopaenia (platelet count \< 100,000/mm3)
• \. Severe heart disease (ischaemic heart disease, heart failure)
• \. Uncontrolled hypertension, despite antihypertensive therapy
• \. 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
• \. History of malignancy
• \. 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
• \. Known serious allergy to any agents used in the study

Sponsors & Collaborators

• Hokkaido University Hospital: lead
• Japan Agency for Medical Research and Development: collaborator

Study Sites (1)

Hokkaido University Hospital

Sapporo, Hokkaido, 0608638, Japan

RECRUITING

MeSH Terms

Conditions

Cerebral Hemorrhage; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Central Study Contacts

Masahito Kawabori, MD, PHD

CONTACT

+81117065987; masahitokawabori@yahoo.co.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: April 11, 2024
• Study Start: December 1, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)