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Clinical study of autologous bone marrow mesenchymal stem cells in the treatment of dysfunction of cerebral ischemic stroke

Clinical study of autologous bone marrow mesenchymal stem cells in the treatment of dysfunction of cerebral ischemic stroke

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035059
Enrollment
Unknown
Registered
2020-07-29
Start date
2020-07-31
Completion date
Unknown
Last updated
2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysfunction of cerebral ischemic stroke

Interventions

low dose experiment group:ABMSCs transplant, 5000000 cells each time,total three times
moderate dose experiment group:ABMSCs transplant,10000000 cells each time,total three times
high dose experiment group:ABMSCs transplant,20000000 cells each time,total three times

Sponsors

Shanghai Oriental Hospital Affiliated to Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. The subjects were 40-65 years old, male and female; 2. Patients diagnosed with ischemic stroke within 6 ~ 24 months after stroke; 3. Moderate stroke patients with NIHSS score of 8-12; 4. Patients or their guardians agree to accept the treatment plan and sign the informed consent form; 5. Patients can cooperate with the collection and preservation of medical history data and follow-up process.

Exclusion criteria

Exclusion criteria: Any of the following conditions could not be included in the experimental group. 1. All kinds of patients with needle syncope; 2. Patients with various acute diseases; 3. Patients with severe disability and serious diseases at the end of the period; 4. Patients with severe gravity, liver and kidney dysfunction; 5. Patients with lung infection or severe infection of other organs; 6. Patients with a history of severe allergic reactions; 7. The patients who have used immunosuppressive drugs within 3 months, including steroids and vaccination history within half a year; 8. All patients with brain organic lesions that cause intracranial hypertension; 9. Patients who are or have been suffering from cancer; 10. Patients with positive serum HIV, syphilis antibody, hepatitis B, hepatitis C or other serious infectious diseases; 11. Patients with severe mental illness or disturbance of consciousness; 12. Patients with coagulation dysfunction or receiving anticoagulant therapy; 13. Patients with uncontrollable hypertension had blood pressure >= 180 / 110 mmHg after treatment; 14. Patients with severe diabetes mellitus complicated with late complications; patients with other diseases affecting limb activities (including claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis, etc.) before treatment; 15. Patients who have participated in other clinical studies within 3 months; 16. Patients who have experienced surgery and trauma (including fractures) in the past month; 17. According to the judgment of the researcher, there are patients who are not suitable to participate in this clinical study.

Design outcomes

Primary

MeasureTime frame
Safety indexs;NIHSS scores;

Secondary

MeasureTime frame
Brain MRI;mRS scores;Doppler tissue imaging;Surface electromyography;Cerebrospinal fluid neurotransmitter;Cerebrospinal fluid nutritional factor;

Countries

China

Contacts

Public ContactJingwen Wu

Shanghai Oriental Hospital Affiliated to Tongji University

wujingwen211@126.com+86 18916111526

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026