Autologous Bone Marrow Mesenchymal Stem Cell Therapy for Ischemic Stroke

NCT ID: NCT06997939

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ommaya Reservoir Group

Stem Cell via Ommaya；2\*10\^7 cells dose

Group Type: EXPERIMENTAL

ABMSC

Intervention Type: BIOLOGICAL

Autologous bone marrow-derived mesenchymal stem cells administered via Ommaya reservoir；2.0\*10\^7 cell/dose

Low-Dose intra-arterial transplantation group

Internal carotid artery(ICA) transplantation；Low-dose; 2.5\*10\^6 cells dose

Group Type: EXPERIMENTAL

ABMSC

Intervention Type: BIOLOGICAL

Autologous bone marrow-derived mesenchymal stem cells via intra-arterial route；Low-dose group; 2.5\*10\^6 cell/dose

High-Dose intra-arterial transplantation group

Internal carotid artery(ICA) transplantation；High-dose; 1.0\*10\^7 cells dose

Group Type: EXPERIMENTAL

ABMSC

Intervention Type: BIOLOGICAL

Autologous bone marrow-derived mesenchymal stem cells via intra-arterial route；High-dose group; 1.0\*10\^7 cell/dose

Interventions

ABMSC

Autologous bone marrow-derived mesenchymal stem cells administered via Ommaya reservoir；2.0\*10\^7 cell/dose

Intervention Type: BIOLOGICAL

ABMSC

Autologous bone marrow-derived mesenchymal stem cells via intra-arterial route；Low-dose group; 2.5\*10\^6 cell/dose

Intervention Type: BIOLOGICAL

ABMSC

Autologous bone marrow-derived mesenchymal stem cells via intra-arterial route；High-dose group; 1.0\*10\^7 cell/dose

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Age 18-65 years, both male and female
• Confirmed diagnosis of ischemic stroke within 3-12 months before enrollment.
• Moderate stroke with NIHSS score 5-12 at screening
• Modified Rankin Scale (mRS) score 3-5 (moderate to severe disability)
• Patient or legal guardian willing to provide written informed consent for treatment and study participation
• Able to comply with medical history collection, data storage, and follow-up procedures

Exclusion Criteria

• Patients with needle phobia or lumbar spine disease affecting bone marrow aspiration
• Any acute illness at the time of screening
• Severe disability or end-stage disease
• Severe heart, liver, or kidney dysfunction
• Pulmonary infection or severe systemic infection
• History of severe allergic reactions
• Use of immunosuppressive drugs (e.g., steroids) within 3 months or vaccination within 6 months
• Any organic lesions causing increased intracranial pressure
• Current or past malignancy
• Seropositive for HIV, syphilis, hepatitis B, hepatitis C, or other severe infectious diseases
• Severe mental illness or impaired consciousness
• Coagulopathy or ongoing anticoagulant therapy
• Blood pressure ≥180/110 mmHg despite treatment
• Poorly controlled diabetes with advanced complications and Pre-existing conditions affecting limb mobility (e.g., claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis)
• Participation in another clinical trial within 3 months
• Major surgery or trauma (including fractures) within 1 month
• Any other condition deemed unsuitable for study participation by the investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantong Shengyuan Stem Cell Techology Co., Ltd

UNKNOWN

Sponsor Role: collaborator

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qiuhong Ji, MD, PhD

Role: STUDY_CHAIR

Affiliated Hospital of Nantong University

Locations

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Countries

China

Central Contacts

Qiuhong Ji, MD, PhD

Role: CONTACT

jiqiuhong@ntu.edu.cn

+8613962916293

Facility Contacts

Qiuhong Ji, MD, PhD

Role: primary

jiqiuhong@ntu.edu.cn

+8613962916293

Tian Xu, MD, PhD

Role: backup

xutian84@163.com

+8618251313276

Other Identifiers

2025-G097

Identifier Type: -

Identifier Source: org_study_id