NCT01461720

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

3.8 years

First QC Date

October 25, 2011

Last Update Submit

March 30, 2015

Conditions

Middle Cerebral Artery Infarction

Keywords

Bone marrowAutologousMesenchymal stem cellsUnilateral middle cerebral artery infarct

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Change in Stroke Specific Quality of Life Scale

    1 year

  • Change in Stroke Impact Scale

    1 year

Study Arms (2)

Standard medical care

OTHER

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

Other: Standard medical care

BM-MSCs

EXPERIMENTAL

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

Other: Standard medical careBiological: Autologous bone marrow-derived mesenchymal stem cells

Interventions

Standard medical careOTHER

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

BM-MSCsStandard medical care
Autologous bone marrow-derived mesenchymal stem cellsBIOLOGICAL

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

BM-MSCs

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UKM Medical Centre

Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Conditions

Infarction, Middle Cerebral Artery

Condition Hierarchy (Ancestors)

Cerebral InfarctionBrain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Arterial DiseasesIntracranial Arterial DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Norlinah Mohamed Ibrahim, MD

    UKM Medical Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Norlinah Mohamed Ibrahim, MD

CONTACT

norlinah@ppukm.ukm.edu.my, norlinah@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Neurologist

Study Record Dates

First Submitted

October 25, 2011

First Posted

October 28, 2011

Study Start

March 1, 2012

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

MY(1)