The purpose of this pilot study is to evaluate the safety of stromal vascular fraction (SVF) therapy in patients with spontaneous intracerebral hemorrhage (SICH).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
The active treatment is an intravenous injection with the stromal vascular fraction (SVF) harvested from the patient's own fatty tissue.
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGOccurrence of adverse events
Number of adverse events at each Stromal vascular fraction (SVF) dose following infusion.
Time frame: 1 year
The changes in stroke-related neurologic deficit
The changes in stroke-related neurologic deficit were measured by the National Institute of Health stroke scale (NIHSS), which ranges from 0 to 45. Higher scores indicate worse neurological function.
Time frame: baseline, Month 1, Month 3, Month 6, Month 9, Month 12
The changes in patients' language function
The changes in patients' language function were measured by the Western Aphasia Battery (WAB), which ranges from 0 to 100. Higher scores indicate better language function.
Time frame: baseline, Month 1, Month 3, Month 6, Month 9, Month 12
The changes in patients' sensorimotor function
The changes in patients' language function were measured by the Fugl-Meyer Assessment (FMA), which ranges from 0 to 226. Higher scores indicate better language function.
Time frame: baseline, Month 1, Month 3, Month 6, Month 9, Month 12
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