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Stem Cell Therapy for Intracerebral Hemorrhage
Sponsor: Tang Zhouping
Summary
Intracerebral hemorrhage (ICH) is a common condition with high morbidity, mortality, and disability. The current treatments for ICH primarily include surgical and pharmacological interventions. For large hematomas, surgical options such as craniotomy, debridement, decompression, and minimally invasive hematoma aspiration may be performed. Pharmacological treatments are mainly symptomatic. Despite timely and standardized surgical or pharmacological interventions, many patients with ICH still experience significant sequelae, which severely affect their quality of life and place a substantial burden on both families and society. Currently, there are limited drugs available specifically for the treatment of ICH. In recent years, stem cell therapy has gained attention as a promising treatment for neurological diseases. Human umbilical cord mesenchymal stem cells (UC-MSCs) are multifunctional stem cells with properties such as self-renewal, multidirectional differentiation potential, tissue repair, immunomodulation, and anti-inflammatory effects. Studies have shown that intravenous transplantation of UC-MSCs is safe, and their application in the treatment of ICH can reduce hematoma volume, attenuate cerebral edema and inflammation, and promote the recovery of neurological function. These findings offer a novel therapeutic strategy for ICH. The purpose of this clinical trial is to evaluate the safety and efficacy of UC-MSCs transplantation in patients with subacute intracerebral hemorrhage, and providing a potential new therapeutic approach for this challenging condition.
Official title: Clinical Research on Umbilical Cord Mesenchymal Stem Cells Therapy for Patients With Subacute Intracerebral Hemorrhage
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
39
Start Date
2025-03-01
Completion Date
2027-07-31
Last Updated
2025-03-06
Healthy Volunteers
No
Interventions
Device: Phase Ⅰ Dose Level 1
Patients in the first dose level will receive a cell dose of 1×10\^6 cells/kg.
Device: Phase Ⅰ Dose Level 2
Patients in the second dose level will receive a cell dose of 2×10\^6 cells/kg.
Device: Phase Ⅰ Dose Level 3
Patients in the third dose level will receive a cell dose of 4×10\^6 cells/kg. Based on these findings, the maximum tolerated dose (MTD) will be determined.
Device: Phase II MTD in Phase I
This group subjects received the MTD obtained in phase I.
Device: Phase II lower than the MTD in Phase I
This group subjects received a dose lower than the MTD