Status:
NOT_YET_RECRUITING
Autologous Bone Marrow Mesenchymal Stem Cell Therapy for Ischemic Stroke
Lead Sponsor:
Affiliated Hospital of Nantong University
Collaborating Sponsors:
Nantong Shengyuan Stem Cell Techology Co., Ltd
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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 developm...
Eligibility Criteria
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
- 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 (including fractures) within 1 month
- Any other condition deemed unsuitable for study participation by the investigator
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06997939
Start Date
June 1 2025
End Date
May 31 2027
Last Update
May 31 2025
Active Locations (1)
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1
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226000