Stem Cell Therapy for Intracerebral Hemorrhage

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.

Conditions

• Intracerebral Hemorrhage
• Mesenchymal Stem Cell

Interventions

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

Sponsors & Collaborators

• Wuhan Hamilton Biotechnology Co., Ltd

  collaborator UNKNOWN

• Tang Zhouping

  lead OTHER

Principal Investigators

• Zhouping Tang, M.D. · Tongji Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-01

Primary Completion

2027-02-28

Completion

2027-07-31