Status:
UNKNOWN
Intravenous Autologous Mesenchymal Stem Cells Transplantation to Treat Middle Cerebral Artery Infarct
Lead Sponsor:
National University of Malaysia
Collaborating Sponsors:
Cytopeutics Sdn. Bhd.
Conditions:
Middle Cerebral Artery Infarction
Eligibility:
All Genders
30-75 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01461720
Start Date
March 1 2012
End Date
March 1 2016
Last Update
April 1 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UKM Medical Centre
Kuala Lumpur, Malaysia, 56000