Stroke Clinical Trial
— AMETISOfficial title:
Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Patients With Ischemic Stroke: a Randomized Controlled Trial
Verified date | April 2021 |
Source | Southern Medical University, China |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the feasibility, efficacy, and safety of autologous transplantation of ex vivo expanded bone marrow stromal cells (BMSCs)and endothelial progenitor cells (EPCs) for treatment of patients with ischemic stroke.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 2017 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Patients aged 18 to 80 years, within 7 days of the onset of symptoms 2. Ischemic lesion within the MCA territory as assessed using diffusion-weighted imaging (DWI) 3. The National Institutes of Health Stroke Scale (NIHSS) = 7 at day 7 after the onset 4. Signed informed consent Exclusion Criteria: 1. Lacunar syndrome 2. Diagnosis other than ischemic stroke(eg. Intracranial hemorrhage or Intracranial tumor) 3. Hematological causes of stroke 4. Severe respiratory, hepatic, or renal disorders 5. Presence of severe febrile illness or viral diseases 6. Malignant diseases 7. Presence of autoimmune diseases 8. Positive response of penicillin skin test, or multiple drug allergies 9. Breast-feeding or pregnant women |
Country | Name | City | State |
---|---|---|---|
China | Zhujiang Hospital, Southern Medical University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Southern Medical University, China | Cellonis Biotechnology Co. Ltd., The First People's Hospital of Haizhu District Guangzhou, The Second People's Hospital of Nanhai District of Foshan |
China,
Bang OY, Lee JS, Lee PH, Lee G. Autologous mesenchymal stem cell transplantation in stroke patients. Ann Neurol. 2005 Jun;57(6):874-82. — View Citation
Lee JS, Hong JM, Moon GJ, Lee PH, Ahn YH, Bang OY; STARTING collaborators. A long-term follow-up study of intravenous autologous mesenchymal stem cell transplantation in patients with ischemic stroke. Stem Cells. 2010 Jun;28(6):1099-106. doi: 10.1002/stem.430. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of adverse events after infusion of BMSCs or EPCs. | 1 year | ||
Secondary | Changes in functional outcomes measured by the modified Rankin Scale (mRS) and the Barthel index (BI). | 1 year |
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