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

Primary Purpose

Middle Cerebral Artery Infarction

Status
Unknown status
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
Standard medical care
Autologous bone marrow-derived mesenchymal stem cells
Sponsored by
National University of Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Middle Cerebral Artery Infarction focused on measuring Bone marrow, Autologous, Mesenchymal stem cells, Unilateral middle cerebral artery infarct

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • UKM Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Standard medical care

BM-MSCs

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in NIH Stroke Scale
Change in Barthel Index
Change in modified Rankin Scale
Change in size of infarct based on brain MRI stroke sequences

Secondary Outcome Measures

Change in Stroke Specific Quality of Life Scale
Change in Stroke Impact Scale

Full Information

First Posted
October 25, 2011
Last Updated
March 30, 2015
Sponsor
National University of Malaysia
Collaborators
Cytopeutics Sdn. Bhd.
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1. Study Identification

Unique Protocol Identification Number
NCT01461720
Brief Title
Intravenous Autologous Mesenchymal Stem Cells Transplantation to Treat Middle Cerebral Artery Infarct
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Malaysia
Collaborators
Cytopeutics Sdn. Bhd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Middle Cerebral Artery Infarction
Keywords
Bone marrow, Autologous, Mesenchymal stem cells, Unilateral middle cerebral artery infarct

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard medical care
Arm Type
Other
Arm Description
This is the control arm, which is given the best evidence-based standard treatment for the management of acute stroke
Arm Title
BM-MSCs
Arm Type
Experimental
Arm Description
Autologous bone marrow-derived mesenchymal stem cells(BM-MSCs)
Intervention Type
Other
Intervention Name(s)
Standard medical care
Intervention Description
Standard medical care includes treatment to prevent recurrence, optimal control of risk factors and post stroke follow-up rehabilitative treatment.
Intervention Type
Biological
Intervention Name(s)
Autologous bone marrow-derived mesenchymal stem cells
Intervention Description
Single intravenous infusion of autologous bone marrow-derived mesenchymal stem cells concurrently with standard medical care.
Primary Outcome Measure Information:
Title
Change in NIH Stroke Scale
Time Frame
1 year
Title
Change in Barthel Index
Time Frame
1 year
Title
Change in modified Rankin Scale
Time Frame
1 year
Title
Change in size of infarct based on brain MRI stroke sequences
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in Stroke Specific Quality of Life Scale
Time Frame
1 year
Title
Change in Stroke Impact Scale
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Norlinah Mohamed Ibrahim, MD
Email
norlinah@ppukm.ukm.edu.my, norlinah@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norlinah Mohamed Ibrahim, MD
Organizational Affiliation
UKM Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
UKM Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norlinah Mohamed Ibrahim, MD
First Name & Middle Initial & Last Name & Degree
Norlinah Mohamed Ibrahim, MBBCH,MRCP,BAO
First Name & Middle Initial & Last Name & Degree
Hui-Jan Tan, MRCP, MMed

12. IPD Sharing Statement

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

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