NCT06862388

Stem Cell Therapy for Intracerebral Hemorrhage

Clinical Research on Umbilical Cord Mesenchymal Stem Cells Therapy for Patients With Subacute Intracerebral Hemorrhage

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Tang Zhouping · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This clinical trial is divided into two phases: Phase I and Phase II. The Phase I clinical trial is a single-center, open-label, dose-escalation study. It follows a 3+3 dose-escalation design and includes the following phases: screening/baseline phase, stem cell treatment phase, safety and tolerability observation phase, and follow-up phase, with a total of 10 visits. The primary focus of Phase I is to assess the safety of stem cell treatment. There are three dose groups, with at least 3 subjects in each group. Each subject will receive a cell dose of 1×10\^6 cells/kg, 2×10\^6 cells/kg, or 4×10\^6 cells/kg. Phase I will enroll patients with subacute intracerebral hemorrhage who meet all inclusion and exclusion criteria. In line with the 3+3 dose-escalation design, human umbilical cord mesenchymal stem cells (UC-MSCs) will be intravenously administered at the designated doses at specific time points. The study will then observe both the primary and secondary safety endpoints following transplantation. The Phase II clinical trial is also a single-center, open-label study. It is an exploratory efficacy study, consisting of a screening/baseline phase, stem cell treatment phase, and follow-up phase, with 8 visits in total. The primary objective of Phase II is to evaluate the safety and efficacy of UC-MSCs in the treatment of subacute intracerebral hemorrhage. The Phase II trial will consist of two groups, each with 15 subjects, for a total of 30 participants. The specific number of cells to be transplanted will be determined based on the findings from Phase I. UC-MSCs or saline will be intravenously infused into the subjects at designated time points, and visits will be scheduled according to the study plan. The primary safety and efficacy endpoints, as well as secondary endpoints, will be closely monitored after transplantation.

Conditions

• Intracerebral Hemorrhage
• Mesenchymal Stem Cell

Interventions

Type	Name	Description
BIOLOGICAL	Device: Phase Ⅰ Dose Level 1	Patients in the first dose level will receive a cell dose of 1×10\^6 cells/kg.
BIOLOGICAL	Device: Phase Ⅰ Dose Level 2	Patients in the second dose level will receive a cell dose of 2×10\^6 cells/kg.
BIOLOGICAL	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.
BIOLOGICAL	Device: Phase II MTD in Phase I	This group subjects received the MTD obtained in phase I.
BIOLOGICAL	Device: Phase II lower than the MTD in Phase I	This group subjects received a dose lower than the MTD

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-02-28
• Completion: 2027-07-31
• First posted: 2025-03-06
• Last updated: 2025-03-06