Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-28 @ 11:21 PM
Study NCT ID:
NCT05232903
Status:
UNKNOWN
Last Update Posted:
2022-03-02
First Post:
2021-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stromal Vascular Fraction (SVF) Therapy in Patients With Acute Spontaneous Intracerebral Hemorrhage (SICH).
Sponsor:
Beijing Tiantan Hospital
Organization:
Study Overview
Official Title:
Safety of Stromal Vascular Fraction (SVF) Therapy in Patients With Acute Spontaneous Intracerebral Hemorrhage (SICH): a Phase I Clinical Study
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
RECRUITING
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:
None
Brief Summary:
The purpose of this pilot study is to evaluate the safety of stromal vascular fraction (SVF) therapy in patients with spontaneous intracerebral hemorrhage (SICH).
Detailed Description:
Spontaneous intracerebral hemorrhage (SICH) is a form of brain parenchymal hemorrhage caused by various non-traumatic reasons, resulting in cerebral artery, veins or capillaries rupture. SICH is a common neurological emergency with the characteristics of rapid onset, dangerous conditions, and a high disability and fatality rate. Although the fatality rate has decreased, reflecting the progress of recent medical technologies, most patients still have persistent language or limb movement dysfunction.
Stromal vascular fraction (SVF) is a structural framework in the body's fat tissue, comprising mesenchymal stem cells, white blood cells, red blood cells, endothelial cells, T cells, platelets related cytokines. Previous studies have demonstrated that SVF has favorable therapeutic effects against various diseases regarding different systems, including the motor system, respiratory system, circulatory system, and nervous system, which indicated the treatment potential of SVF in the treatment of SICH.
The overall clinical development strategy of this project is to conduct a Phase I dose-escalation study to evaluate the safety of SVF therapy in patients with SICH. Fifteen patients with SICH will be sequentially assigned to 3 dose groups, and the adverse events (AEs) and serious adverse events (SAEs) will be recorded in a period of 1 year.
Stromal vascular fraction (SVF) is a structural framework in the body's fat tissue, comprising mesenchymal stem cells, white blood cells, red blood cells, endothelial cells, T cells, platelets related cytokines. Previous studies have demonstrated that SVF has favorable therapeutic effects against various diseases regarding different systems, including the motor system, respiratory system, circulatory system, and nervous system, which indicated the treatment potential of SVF in the treatment of SICH.
The overall clinical development strategy of this project is to conduct a Phase I dose-escalation study to evaluate the safety of SVF therapy in patients with SICH. Fifteen patients with SICH will be sequentially assigned to 3 dose groups, and the adverse events (AEs) and serious adverse events (SAEs) will be recorded in a period of 1 year.
Study Oversight
Has Oversight DMC:
True
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?: