Middle Cerebral Artery InfarctionPhase 2NCT01461720
Intravenous Autologous Mesenchymal Stem Cells Transplantation to Treat Middle Cerebral Artery Infarct
A Phase 2 study testing Standard medical care and Autologous bone marrow-derived mesenchymal stem cells in people with Middle Cerebral Artery Infarction, run by National University of Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Middle Cerebral Artery Infarction
- What is being tested?
- Standard medical care and Autologous bone marrow-derived mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMalaysia
- Study dates
- Mar 2012to Mar 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Norlinah Mohamed Ibrahim, MD contact
Malaysia1 site, 1 recruiting
- Recruiting
UKM Medical Centre
Kuala Lumpur, 56000
Norlinah Mohamed Ibrahim, MD
Norlinah Mohamed Ibrahim, MBBCH,MRCP,BAO
About this study
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
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.
- Conditions
- Middle Cerebral Artery Infarction
- Being tested
- Standard medical care, Autologous bone marrow-derived mesenchymal stem cells
- Keywords
- Bone marrow, Autologous, Mesenchymal stem cells, Unilateral middle cerebral artery infarct
- Medical subject headings
- Infarction, Middle Cerebral Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard medical careOther
Standard medical care includes treatment to prevent recurrence, optimal control of risk factors and post stroke follow-up rehabilitative treatment.
Autologous bone marrow-derived mesenchymal stem cellsBiological
Single intravenous infusion of autologous bone marrow-derived mesenchymal stem cells concurrently with standard medical care.
| Study group | Role | What they receive |
|---|---|---|
| Standard medical care | Other | This is the control arm, which is given the best evidence-based standard treatment for the management of acute stroke Receives: Other: Standard medical care |
| BM-MSCs | Experimental | Autologous bone marrow-derived mesenchymal stem cells(BM-MSCs) Receives: Other: Standard medical care; Biological: Autologous bone marrow-derived mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NIH Stroke Scale
Measured: 1 year
Change in Barthel Index
Measured: 1 year
Change in modified Rankin Scale
Measured: 1 year
Change in size of infarct based on brain MRI stroke sequences
Measured: 1 year
Secondary outcomes (2)
Change in Stroke Specific Quality of Life Scale
Measured: 1 year
Change in Stroke Impact Scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startMar 2012
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Middle Cerebral Artery InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Cytopeutics Sdn. Bhd.
- Responsible party
- Principal investigator, Dr Norlinah Mohamed Ibrahim, National University of Malaysia
- Investigators
- Norlinah Mohamed Ibrahim, MD, Principal investigator, UKM Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461720
- Sponsor's protocol ID
- FF-115-2011
- Status last verified
- Mar 2015
- First submitted
- 25 Oct 2011
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01461720
- Acronym / sponsor ID
- FF-115-2011
- Conditions
- Middle Cerebral Artery Infarction
- Keywords
- Bone marrow, Autologous, Mesenchymal stem cells, Unilateral middle cerebral artery infarct
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- Cytopeutics Sdn. Bhd.
- Study start
- Mar 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 28 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard medical care | Other | Other: Standard medical careThis is the control arm, which is given the best evidence-based standard treatment for the management of acute stroke |
| BM-MSCs | Experimental | Other: Standard medical care, Biological: Autologous bone marrow-derived mesenchymal stem cellsAutologous bone marrow-derived mesenchymal stem cells(BM-MSCs) |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard medical careStandard medical care includes treatment to prevent recurrence, optimal control of risk factors and post stroke follow-up rehabilitative treatment. | Other | BM-MSCs, Standard medical care |
| Autologous bone marrow-derived mesenchymal stem cellsSingle intravenous infusion of autologous bone marrow-derived mesenchymal stem cells concurrently with standard medical care. | Biological | BM-MSCs |
Primary outcome
Change in NIH Stroke Scale
Time frame: 1 year
Change in Barthel Index
Time frame: 1 year
Change in modified Rankin Scale
Time frame: 1 year
Change in size of infarct based on brain MRI stroke sequences
Time frame: 1 year
2 secondary outcomes
Change in Stroke Specific Quality of Life Scale
Time frame: 1 year
Change in Stroke Impact Scale
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norlinah Mohamed Ibrahim, MD contact
Norlinah Mohamed Ibrahim, MD principal investigator
UKM Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard medical care and Autologous bone marrow-derived mesenchymal stem cells in people with Middle Cerebral Artery Infarction, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Norlinah Mohamed Ibrahim, MD (norlinah@ppukm.ukm.edu.my, norlinah@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NIH Stroke Scale (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.