Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke

• Register: ClinicalTrials.gov
• Last refreshed on: 12 October 2015
• Main ID: NCT02564328
• Date of registration: 29/09/2015
• Prospective Registration: No
• Primary sponsor: Southern Medical University, China
• Public title: Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke
• Scientific title: Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke
• Date of first enrolment: November 2014
• Target sample size: 40
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02564328
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

China

Contacts

• Name: Xiaodan Jiang, MD,PhD
• Affiliation: Southern Medical University

• Name: Xiaodan Jiang, MD,PhD

• Name: Xiaodan Jiang, MD,PhD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Aged 18-80 chronic ischemia stroke or patients

- With stroke history of more than 6 months, less than 60 months

- NIHSS (NIH stroke scale) score of 7 or more points

- Internal carotid artery territory infarction measured by MRI

- Can be hospitalized and signed informed consent

- With fewer effect by traditional post-stroke treatments or rehabilitations

Exclusion Criteria:

- Lacunar infarction

- Recurrent thrombotic diseases less than 6 months

- Hemorrhage stroke,brain tumor or MRI show the occlusion is not in the middle cerebral
artery territory

- Pregnant women

- Can't tolerate the test because of other disease, such as heart failure, liver
failure, renal failure, abnormal blood coagulation, AIDS, combine other tumor or
special condition

- Penicillin anaphylaxis or some other drugs allergy

- Autoimmune disease

- Inaccessibility for follow up



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Stroke

Intervention(s)

Genetic: Intravenous stem cell transplantation

Primary Outcome(s)

Change from baseline in Fugl-Meyer Scale at 12 months [Time Frame: 1,3,6 and 12 months]

Secondary Outcome(s)

Improvement of vision measured by brain visual examination [Time Frame: 1,6 and 12 months]

Change from baseline in mRS at 12 months [Time Frame: 1,3,6 and 12 months]

Change from baseline in SSS at 12 months [Time Frame: 1,3,6 and 12 months]

Change from baseline in Barthel Index at 12 months [Time Frame: 1,3,6 and 12 months]

Change from baseline in NIH Stroke Scale at 12 months [Time Frame: 1,3,6 and 12 months]

Secondary ID(s)

201400000003-2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Second Affiliated Hospital of Guangzhou Medical University