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

March 30, 2015 updated by: Dr Norlinah Mohamed Ibrahim, National University of Malaysia

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 56000
        • Recruiting
        • UKM Medical Centre
        • Contact:
          • Norlinah Mohamed Ibrahim, MD
        • Principal Investigator:
          • Norlinah Mohamed Ibrahim, MBBCH,MRCP,BAO
        • Sub-Investigator:
          • Hui-Jan Tan, MRCP, MMed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard medical care
This is the control arm, which is given the best evidence-based standard treatment for the management of acute stroke
Other: Standard medical care
Standard medical care includes treatment to prevent recurrence, optimal control of risk factors and post stroke follow-up rehabilitative treatment.
Experimental: BM-MSCs
Autologous bone marrow-derived mesenchymal stem cells(BM-MSCs)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in NIH Stroke Scale
Time Frame: 1 year
1 year
Change in Barthel Index
Time Frame: 1 year
1 year
Change in modified Rankin Scale
Time Frame: 1 year
1 year
Change in size of infarct based on brain MRI stroke sequences
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Stroke Specific Quality of Life Scale
Time Frame: 1 year
1 year
Change in Stroke Impact Scale
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Malaysia

Collaborators

Cytopeutics Sdn. Bhd.

Investigators

  • Principal Investigator: Norlinah Mohamed Ibrahim, MD, UKM Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

October 25, 2011

First Submitted That Met QC Criteria

October 26, 2011

First Posted (Estimate)

October 28, 2011

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF-115-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Middle Cerebral Artery Infarction

Clinical Trials on Standard medical care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe