Ischemic Stroke
Conditions
Keywords
autologous, bone marrow mesenchymal stem cell, mRS, functional recovery, Carotid artery intervention, NIHSS
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.
Interventions
BIOLOGICALABMSC
Autologous bone marrow-derived mesenchymal stem cells administered via Ommaya reservoir；2.0\*10\^7 cell/dose
Sponsors
Nantong Shengyuan Stem Cell Techology Co., Ltd
Affiliated Hospital of Nantong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind design: Participants and investigators are masked to treatment allocation.
Intervention model description
Single-center, three-arm parallel randomized controlled trial: Group A (Ommaya reservoir delivery), Group B (low-dose intra-arterial transplantation), and Group C (High-dose intra-arterial transplantation), with double-blinding.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Cerebral infarct volume changes on MRI | 6-month follow-up | The changes during the follow-up period compared with those before treatment |
Countries
China
Contacts
Primary ContactQiuhong Ji, MD, PhD
Outcome results
None listed