NCT06997939Not yet recruitingPhase 1/2
Autologous Bone Marrow Mesenchymal Stem Cell Therapy for Ischemic Stroke
A Clinical Trial of Autologous Bone Marrow-Derived Mesenchymal Stem Cell Transplantation for Precision Therapy in Ischemic Stroke
Source: ClinicalTrials.gov · Last updated 31 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 18 May 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 31 May 2027
- Lead sponsor
- Affiliated Hospital of Nantong University
- Diseases
- Stroke
- NCT number
- NCT06997939
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 12
- From 1 Jun 2025 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Any organic lesions causing increased intracranial pressure
- Blood pressure ≥180/110 mmHg despite treatment
- Participation in another clinical trial within 3 months
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status | Nantong | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.