Middle Cerebral Artery Infarction
Conditions
Keywords
Bone marrow, Autologous, Mesenchymal stem cells, Unilateral middle cerebral artery infarct
Brief summary
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.
Interventions
OTHERStandard medical care
Standard medical care includes treatment to prevent recurrence, optimal control of risk factors and post stroke follow-up rehabilitative treatment.
Single intravenous infusion of autologous bone marrow-derived mesenchymal stem cells concurrently with standard medical care.
Sponsors
Cytopeutics Sdn. Bhd.
National University of Malaysia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Barthel Index | 1 year |
| Change in modified Rankin Scale | 1 year |
| Change in size of infarct based on brain MRI stroke sequences | 1 year |
| Change in NIH Stroke Scale | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Change in Stroke Specific Quality of Life Scale | 1 year |
| Change in Stroke Impact Scale | 1 year |
Countries
Malaysia
Contacts
Primary ContactNorlinah Mohamed Ibrahim, MD
Outcome results
None listed