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

Phase 2

• Conditions: Middle Cerebral Artery Infarction
• Interventions: Other: Standard medical care; Biological: Autologous bone marrow-derived mesenchymal stem cells

• Registration Number: NCT01461720
• Lead Sponsor: National University of Malaysia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-25
• Study First Submitted QC: 2011-10-26
• Study First Posted: 2011-10-28
• Study Start: 2012-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-04-01
• Primary Completion: 2015-12
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BM-MSCs	Autologous bone marrow-derived mesenchymal stem cells	Autologous bone marrow-derived mesenchymal stem cells(BM-MSCs)
Standard medical care	Standard medical care	This is the control arm, which is given the best evidence-based standard treatment for the management of acute stroke
BM-MSCs	Standard medical care	Autologous bone marrow-derived mesenchymal stem cells(BM-MSCs)

Primary Outcome Measures

Name	Time	Method
Change in NIH Stroke Scale	1 year
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

Secondary Outcome Measures

Name	Time	Method
Change in Stroke Specific Quality of Life Scale	1 year
Change in Stroke Impact Scale	1 year

Trial Locations

Locations (1)

UKM Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia