Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361433
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-01-25
Brief Title:
Intracerebral Transplantation of Autologous MSC Combined With Scaffold Product for Chronic Intracerebral Hemorrhage
Sponsor:
Hokkaido University Hospital
Organization:
Hokkaido University Hospital
Study Overview
Official Title:
Phase III Trial of Intracerebral Transplantation of Autologous Bone Marrow Stromal Cells Combined With Recombinant Peptide Scaffold for Patients With Chronic Intracerebral Hemorrhage
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAINBOW-Hx
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
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 III 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 50000 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
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 III 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 50000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None