A Phase 1/2 interventional study of ABMSC and ABMSC in Ischemic Stroke, sponsored by Affiliated Hospital of Nantong University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by Affiliated Hospital of Nantong University · Phase 1/2, Interventional, and Treatment
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.
2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.
This study's planned enrollment of 12 is below the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Affiliated Hospital of Nantong University is the lead sponsor of 94 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Stem Cell via Ommaya；2\*10\^7 cells dose
Biological: ABMSC
Internal carotid artery(ICA) transplantation；Low-dose; 2.5\*10\^6 cells dose
Biological: ABMSC
Internal carotid artery(ICA) transplantation；High-dose; 1.0\*10\^7 cells dose
Biological: ABMSC
Autologous bone marrow-derived mesenchymal stem cells administered via Ommaya reservoir；2.0\*10\^7 cell/dose
Autologous bone marrow-derived mesenchymal stem cells via intra-arterial route；Low-dose group; 2.5\*10\^6 cell/dose
Autologous bone marrow-derived mesenchymal stem cells via intra-arterial route；High-dose group; 1.0\*10\^7 cell/dose
Adverse events and serious adverse events
To assess safety, the number of AEs or SAEs will be evaluated
Time frame: 3-7 days post each transplantation and 6-month follow-up
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
Time frame: 3-7 days post each transplantation and 6-month follow-up
Modified Rankin Scale(mRS) score
The changes during the treatment, observation period and follow-up period compared with those before treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3-7 days post each transplantation and 6-month follow-up
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2025; primary completion for May 2027, 23 months later.
Of 28 phase 1/2 interventional studies under Ischemic Stroke, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 76. This study's planned 23 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Affiliated Hospital of Nantong University