NCT06997939

Autologous Bone Marrow Mesenchymal Stem Cell Therapy for Ischemic Stroke

A Clinical Trial of Autologous Bone Marrow-Derived Mesenchymal Stem Cell Transplantation for Precision Therapy in Ischemic Stroke

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Affiliated Hospital of Nantong University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Stroke is a group of diseases mainly characterized by cerebral ischemia or hemorrhage, with a high fatality rate and disability rate. It has now become a major obstacle to social and economic development. Stem cells are a type of primitive cells with self-renewal, proliferation and differentiation potential. Under certain conditions, they can differentiate into cells of various tissues and organs. They have now become one of the key research directions for the repair of functional disorders after ischemic stroke. Compared with other types of stem cells, bone marrow mesenchymal stem cells (BMSCs) have the advantages of being relatively easy to obtain with less tissue damage, convenient and rapid in vitro expansion and culture, and the ability to actively migrate to the lesion area after injection without the risk of canceration. This study plans to recruit and screen 12 subjects with ischemic stroke, divided into three groups (Ommaya drug reservoir group, low-dose internal carotid artery transplantation group, and high-dose internal carotid artery transplantation group), with 4 subjects in each group, for a clinical study of ABMSCs treatment for functional disorders after ischemic stroke. In accordance with the established treatment protocol, bone marrow will be collected from subjects during the stable phase of their condition, and ABMSCs will be infused three times via Ommaya drug reservoir/internal carotid artery within 1-6 months after collection. The study will assess the improvement of motor function in patients and analyze the feasibility and effectiveness of this therapy, laying a solid foundation for future clinical applications.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
BIOLOGICAL	ABMSC	Autologous bone marrow-derived mesenchymal stem cells administered via Ommaya reservoir；2.0\*10\^7 cell/dose
BIOLOGICAL	ABMSC	Autologous bone marrow-derived mesenchymal stem cells via intra-arterial route；Low-dose group; 2.5\*10\^6 cell/dose
BIOLOGICAL	ABMSC	Autologous bone marrow-derived mesenchymal stem cells via intra-arterial route；High-dose group; 1.0\*10\^7 cell/dose

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2025-05-31
• Last updated: 2025-05-31

Locations

1 site across 1 country: China