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

Middle Cerebral Artery Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01461720
• Other study ID #: FF-115-2011
• Status: Recruiting
• Phase: Phase 2
• First received: October 25, 2011
• Last updated: March 30, 2015
• Start date: March 2012
• Est. completion date: March 2016

Study information

• Verified date: March 2015
• Source: National University of Malaysia
• Contact: Norlinah Mohamed Ibrahim, MD
• Email: norlinah[@]ppukm.ukm.edu.my, norlinah[@]gmail.com
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review BoardMalaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction, Middle Cerebral Artery
• Middle Cerebral Artery Infarction

Intervention

Other:
• Standard medical care
Standard medical care includes treatment to prevent recurrence, optimal control of risk factors and post stroke follow-up rehabilitative treatment.

Biological:
• Autologous bone marrow-derived mesenchymal stem cells
Single intravenous infusion of autologous bone marrow-derived mesenchymal stem cells concurrently with standard medical care.

Locations

Country	Name	City	State
Malaysia	UKM Medical Centre	Kuala Lumpur

Sponsors (2)

Lead Sponsor	Collaborator
National University of Malaysia	Cytopeutics Sdn Bhd

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in NIH Stroke Scale		1 year	Yes
Primary	Change in Barthel Index		1 year	Yes
Primary	Change in modified Rankin Scale		1 year	Yes
Primary	Change in size of infarct based on brain MRI stroke sequences		1 year	Yes
Secondary	Change in Stroke Specific Quality of Life Scale		1 year	No
Secondary	Change in Stroke Impact Scale		1 year	No