Autologous Bone Marrow Mesenchymal Stem Cell Therapy for Ischemic Stroke (NCT06997939) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Autologous Bone Marrow Mesenchymal Stem Cell Therapy for Ischemic Stroke
China12 participantsStarted 2025-06-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (inclu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse events and serious adverse events
Timeframe: 3-7 days post each transplantation and 6-month follow-up