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

National University of Malaysia

Status and phase: Unknown; Phase 2

Conditions: Middle Cerebral Artery Infarction

Treatments: Biological: Autologous bone marrow-derived mesenchymal stem cells; Other: Standard medical care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01461720

FF-115-2011

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Standard medical care

Other group

Description:

This is the control arm, which is given the best evidence-based standard treatment for the management of acute stroke

Treatment:

Other: Standard medical care

BM-MSCs

Experimental group

Description:

Autologous bone marrow-derived mesenchymal stem cells(BM-MSCs)

Treatment:

Biological: Autologous bone marrow-derived mesenchymal stem cells

Other: Standard medical care