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

NCT ID: NCT06361433

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2026-02-28

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

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.

Conditions

Intracerebral Hemorrhage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cell product transplantation

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

Group Type: EXPERIMENTAL

HUFF-01

Intervention Type: DRUG

autologous MSC combined with scaffold

Interventions

HUFF-01

autologous MSC combined with scaffold

Intervention Type: DRUG

Eligibility 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

• 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
• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Japan Agency for Medical Research and Development

OTHER_GOV

Sponsor Role: collaborator

Hokkaido University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Masahito Kawabori

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Masahito Kawabori, MD, PHD

Role: CONTACT

masahitokawabori@yahoo.co.jp

+81117065987

Facility Contacts

Masahito Kawabori

Role: primary

masahitokawabori@yahoo.co.jp

+81117065987

Other Identifiers

R5-11

Identifier Type: -

Identifier Source: org_study_id