StrokePhase 1NCT01714167
Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Stroke
A Phase 1 study testing intracerebral stem cell transplantation in people with Stroke, run by Wenzhou Medical University at 1 site in China.
Trial summary
Stroke is one of the leading causes of disability in the world, and stem cell - transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy of the intracerebral injection of autologous bone marrow mesenchymal stem cells in patients with chronic stroke. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- intracerebral stem cell transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Dec 2015
- Phase
- Phase 1
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 40-70 ischemia stroke or intracerebral hemorrhage patient
- With stroke history of more than 3 months, less than 60 months
- With stable hemiplegia condition
- NIHSS (NIH stroke scale) score of 7 or more points
- Patient is stable (normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar <7 mg, and normal urea/electrolytes for at least 48 hours.)
Who cannot join
- Patients aged less than 40 or more than 70
- Lacunar infarction
- History of neurological disease, head injury or psychiatric disorder with disablity
- Pregnant women
- Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition
- Inaccessibility for follow up
- Unwillingness to provide written informed consent
Trial locations and contacts
1 site in 1 country.
Qichuan Zhuge, M.D. contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 32500
About this study
Official title: Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Treatment of Chronic Stroke
Stroke is one of the leading causes of disability in the world, and stem cell - transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy of the intracerebral injection of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.
Read the detailed description
For many stroke survivors, the best hope is a lengthy program of rehabilitation, followed by a life-long process of clinical support. However, even with rehabilitation therapy, 50% to 95% of stroke survivors remain impaired. There is thus a great need for new therapeutic developments for patients with disability after stroke, which is largely unexplored. Regenerative cell-based therapies offer long-term hope for many patients with stroke, as stem cells might be possible for dead or injured neural cells to be replaced after acute stroke. In this study, the investigators will assess the safety and feasibility of intracerebral transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic stroke. The neurological outcome will be determined after transplantation.
- Conditions
- Stroke
- Being tested
- intracerebral stem cell transplantation
- Keywords
- Chronic, Ischemic Stroke, Intracerebral Hemorrhage, Bone Marrow Mesenchymal Stem Cell
- Medical subject headings
- Stroke, Bronchiolitis Obliterans Syndrome, Ischemic Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracerebral stem cell transplantationGenetic
Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient
| Study group | Role | What they receive |
|---|---|---|
| intracerebral stem cell transplantation | Active comparator | Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient plus conventional treatment include rehabilitation Receives: Genetic: intracerebral stem cell transplantation |
| conventional treatment | No intervention | Control group receive conventional stroke treatment that include rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in NIH Stroke Scale at 12 months
Measured: 1, 6 and 12 months
Secondary outcomes (1)
Improvement of infarct size measured by brain MRI
Measured: 1,6 and 12 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Texas Health Science Center
- Responsible party
- Principal investigator, Qichuan Zhuge, Wenzhou Medical University
- Investigators
- Kunlin Jin, M.D., Ph.D., Study director, University of North Texas Health Science CenterQichuan Zhuge, M.D., Study chair, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714167
- Sponsor's protocol ID
- WZMC-2011-8
- Status last verified
- Jun 2015
- First submitted
- 19 Oct 2012
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Treatment of Chronic Stroke
- ClinicalTrials.gov ID
- NCT01714167
- Acronym / sponsor ID
- WZMC-2011-8
- Conditions
- Stroke
- Keywords
- Chronic, Ischemic Stroke, Intracerebral Hemorrhage, Bone Marrow Mesenchymal Stem Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- University of North Texas Health Science Center
- Study start
- Jun 2012
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Oct 2012 (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.
Stroke is one of the leading causes of disability in the world, and stem cell - transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy of the intracerebral injection of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.
Detailed description
For many stroke survivors, the best hope is a lengthy program of rehabilitation, followed by a life-long process of clinical support. However, even with rehabilitation therapy, 50% to 95% of stroke survivors remain impaired. There is thus a great need for new therapeutic developments for patients with disability after stroke, which is largely unexplored. Regenerative cell-based therapies offer long-term hope for many patients with stroke, as stem cells might be possible for dead or injured neural cells to be replaced after acute stroke. In this study, the investigators will assess the safety and feasibility of intracerebral transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic stroke. The neurological outcome will be determined after transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intracerebral stem cell transplantation | Active comparator | Genetic: intracerebral stem cell transplantationIntracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient plus conventional treatment include rehabilitation |
| conventional treatment | No intervention | –Control group receive conventional stroke treatment that include rehabilitation |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 40-70 ischemia stroke or intracerebral hemorrhage patient
- With stroke history of more than 3 months, less than 60 months
- With stable hemiplegia condition
- NIHSS (NIH stroke scale) score of 7 or more points
- Patient is stable (normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar <7 mg, and normal urea/electrolytes for at least 48 hours.)
Key exclusion criteria (7 listed)
- Patients aged less than 40 or more than 70
- Lacunar infarction
- History of neurological disease, head injury or psychiatric disorder with disablity
- Pregnant women
- Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition
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 |
|---|---|---|
| intracerebral stem cell transplantationIntracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient | Genetic | intracerebral stem cell transplantation |
Primary outcome
Change from baseline in NIH Stroke Scale at 12 months
Time frame: 1, 6 and 12 months
1 secondary outcome
Improvement of infarct size measured by brain MRI
Time frame: 1,6 and 12 months after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 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.
Qichuan Zhuge, M.D. contact
Kunlin Jin, M.D., Ph.D. study director
University of North Texas Health Science Center
Qichuan Zhuge, M.D. study chair
First Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing intracerebral stem cell transplantation in people with Stroke, run by Wenzhou Medical University at 1 site in China.
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 5 inclusion and 7 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 8 Jun 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Qichuan Zhuge, M.D. (zhugeqichuan@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in NIH Stroke Scale at 12 months (time frame: 1, 6 and 12 months). 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 8 Jun 2015.