Intravenous Autologous Mesenchymal Stem Cells Transplantation to Treat Middle Cerebral Artery Infarct

An Open Lable, Phase II Exploratory Study Assessing the Efficacy of Intravenous Autologous Mesenchymal Stem Cells in Patients With Middle Cerebral Artery Infarct

This study aims to determine the efficacy of intravenous transplantation of autologous bone marrow-derived mesenchymal stem cells in patients with acute middle cerebral artery infarct.

Inclusion Criteria:

• Experiences stroke onset within 2 weeks to 2 months
• NIHSS score of >10-35
• Never received or failed thrombolysis
• Evidence of unilateral middle cerebral artery infarct on brain MRI

Exclusion Criteria:

• Medically unfit (eg. those are unstable haemodynamically despite treatment, with worsening conscious level and with other serious medical co-morbidity)
• Evidence of any tumor or other space-occupying lesion on brain MRI
• Evidence of hemorrhagic stroke on brain CT or MRI
• Experiences transient ischemic attack or lacunar infarct
• Has any acute or chronic infections such as Hepatitis B, Hepatitis C and HIV
• Is diagnosed with concurrent malignancy or primary hematological disorders
• Renal impairment indicated with serum creatinine greater than 200 umol/l or creatinine clearance less than 30 ml/min
• Liver impairment indicated with serum aspartate transaminase and serum alanine transaminase greater than 4 times upper limit of the normal range
• Any contraindication to stem cell transplantation or bone marrow biopsy
• Any co-morbidity which will compromise the ability to obtain adequate stem cells (eg. chronic debilitating diseases, frail patients and patients with known osteoporosis)
• Any contraindication to brain MRI (eg. metal implants, pacemaker, joint implants and ocular implants)