Tests patient's own bone marrow stem cells after ischemic stroke
Tests infusions of patients' own bone marrow stem cells in adults with ischemic stroke.
Plain-language title generated from the registry record
Registry title: Autologous Bone Marrow Mesenchymal Stem Cell Therapy for Ischemic Stroke
Key facts
- Where
- Nantong, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06997939, who can take part
Where in China
- Affiliated Hospital of Nantong UniversityNantong, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Affiliated Hospital of Nantong University
- Trial code
- NCT06997939
- Record updated
- 31 May 2025
- Original description
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.Read full original descriptionShow less
A Clinical Trial of Autologous Bone Marrow-Derived Mesenchymal Stem Cell Transplantation for Precision Therapy in Ischemic Stroke
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.
Inclusion: 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: Use of immunosuppressive drugs (e.g., steroids) within 3 months or vaccination within 6 months; Coagulopathy or ongoing anticoagulant therapy; Major surgery or trauma (including fractures) within 1 month; 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; Current or past malignancy; Seropositive for HIV, syphilis, hepatitis B, hepatitis C, or other severe infectious diseases; Severe mental illness or impaired consciousness; Poorly controlled diabetes with advanced complications and Pre-existing conditions affecting limb mobility (e.g., claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis); Any other condition deemed unsuitable for study participation by the investigator; Any organic lesions causing increased intracranial pressure; Blood pressure ≥180/110 mmHg despite treatment; Participation in another clinical trial within 3 months.