Autologous Bone Marrow Mesenchymal Stem Cell Therapy for Ischemic Stroke

Phase 1

Not yet recruiting

• Conditions: Ischemic Stroke
• Interventions: Biological: ABMSC

• Registration Number: NCT06997939
• Lead Sponsor: Affiliated Hospital of Nantong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-18
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-31
• Last Update Posted: 2025-05-31
• Study Start: 2025-06-01
• Primary Completion: 2027-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ommaya Reservoir Group	ABMSC	Stem Cell via Ommaya；2\*10\^7 cells dose
Low-Dose intra-arterial transplantation group	ABMSC	Internal carotid artery(ICA) transplantation；Low-dose; 2.5\*10\^6 cells dose
High-Dose intra-arterial transplantation group	ABMSC	Internal carotid artery(ICA) transplantation；High-dose; 1.0\*10\^7 cells dose

Primary Outcome Measures

Name	Time	Method
Adverse events and serious adverse events	3-7 days post each transplantation and 6-month follow-up	To assess safety, the number of AEs or SAEs will be evaluated

Secondary Outcome Measures

Name	Time	Method
Fugl-Meyer Balance Assessment	3-7 days post each transplantation and 6-month follow-up	The changes during the treatment, observation period and follow-up period compared with those before treatment
10-Meter Walk Test(10MWT) Time	3-7 days post each transplantation and 6-month follow-up	The changes during the treatment, observation period and follow-up period compared with those before treatment
Functional Ambulation Category(FAC)	3-7 days post each transplantation and 6-month follow-up	The changes during the treatment, observation period and follow-up period compared with those before treatment
National Institutes of Health Stroke Scale（NIHSS） score	3-7 days post each transplantation and 6-month follow-up	The changes during the treatment and observation period and follow-up period compared with those before treatment
Modified Rankin Scale(mRS) score	3-7 days post each transplantation and 6-month follow-up	The changes during the treatment, observation period and follow-up period compared with those before treatment
Modified Barthel Index	3-7 days post each transplantation and 6-month follow-up	The changes during the treatment, observation period and follow-up period compared with those before treatment
Fugl-Meyer Assessment	3-7 days post each transplantation and 6-month follow-up	The changes during the treatment, observation period and follow-up period compared with those before treatment
Cerebral infarct volume changes on MRI	6-month follow-up	The changes during the follow-up period compared with those before treatment
Surface electromyography(sEMG) signal changes	3-7 days post each transplantation and 6-month follow-up	The changes during the treatment, observation period and follow-up period compared with those before treatment

Trial Locations

Locations (1)

Affiliated Hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China