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| Name | Class |
|---|---|
| Nantong Shengyuan Stem Cell Techology Co., Ltd | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ommaya Reservoir Group | Experimental | Stem Cell via Ommaya;2*10^7 cells dose |
|
| Low-Dose intra-arterial transplantation group | Experimental | Internal carotid artery(ICA) transplantation;Low-dose; 2.5*10^6 cells dose |
|
| High-Dose intra-arterial transplantation group | Experimental | Internal carotid artery(ICA) transplantation;High-dose; 1.0*10^7 cells dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABMSC | Biological | Autologous bone marrow-derived mesenchymal stem cells administered via Ommaya reservoir;2.0*10^7 cell/dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and serious adverse events | To assess safety, the number of AEs or SAEs will be evaluated | 3-7 days post each transplantation and 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| National Institutes of Health Stroke Scale(NIHSS) score | The changes during the treatment and observation period and follow-up period compared with those before treatment | 3-7 days post each transplantation and 6-month follow-up |
| Modified Rankin Scale(mRS) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiuhong Ji, MD, PhD | Contact | +8613962916293 | jiqiuhong@ntu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Qiuhong Ji, MD, PhD | Affiliated Hospital of Nantong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Nantong University | Nantong | Jiangsu | 226000 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
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Double-blind design: Participants and investigators are masked to treatment allocation.
| ABMSC | Biological | Autologous bone marrow-derived mesenchymal stem cells via intra-arterial route;Low-dose group; 2.5*10^6 cell/dose |
|
| ABMSC | Biological | Autologous bone marrow-derived mesenchymal stem cells via intra-arterial route;High-dose group; 1.0*10^7 cell/dose |
|
The changes during the treatment, observation period and follow-up period compared with those before treatment |
| 3-7 days post each transplantation and 6-month follow-up |
| Modified Barthel Index | The changes during the treatment, observation period and follow-up period compared with those before treatment | 3-7 days post each transplantation and 6-month follow-up |
| Fugl-Meyer Assessment | The changes during the treatment, observation period and follow-up period compared with those before treatment | 3-7 days post each transplantation and 6-month follow-up |
| Fugl-Meyer Balance Assessment | The changes during the treatment, observation period and follow-up period compared with those before treatment | 3-7 days post each transplantation and 6-month follow-up |
| 10-Meter Walk Test(10MWT) Time | The changes during the treatment, observation period and follow-up period compared with those before treatment | 3-7 days post each transplantation and 6-month follow-up |
| Functional Ambulation Category(FAC) | The changes during the treatment, observation period and follow-up period compared with those before treatment | 3-7 days post each transplantation and 6-month follow-up |
| Cerebral infarct volume changes on MRI | The changes during the follow-up period compared with those before treatment | 6-month follow-up |
| Surface electromyography(sEMG) signal changes | The changes during the treatment, observation period and follow-up period compared with those before treatment | 3-7 days post each transplantation and 6-month follow-up |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |