StrokePhase 1NCT02564328
Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke
A Phase 1 study testing Intravenous stem cell transplantation in people with Stroke, run by Southern Medical University, China at 1 site in China.
Trial summary
Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.Stem cell transplantation provides a promising approach for rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Intravenous stem cell transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Nov 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80 chronic ischemia stroke or patients
- With stroke history of more than 6 months, less than 60 months
- NIHSS (NIH stroke scale) score of 7 or more points
- Internal carotid artery territory infarction measured by MRI
- Can be hospitalized and signed informed consent
- With fewer effect by traditional post-stroke treatments or rehabilitations
Who cannot join
- Lacunar infarction
- Recurrent thrombotic diseases less than 6 months
- Hemorrhage stroke,brain tumor or MRI show the occlusion is not in the middle cerebral artery territory
- Pregnant women
- Can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, AIDS, combine other tumor or special condition
- Penicillin anaphylaxis or some other drugs allergy
- Autoimmune disease
- Inaccessibility for follow up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiaodan Jiang
Guangzhou, Guangdong, 510282
Xiaodan Jiang, MD,PhD, 86 20 61643268, jiangxiao_dan@163.com
Xiaodan Jiang, MD,PhD
About this study
Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.Stem cell transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy and safy of the transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.
Read the detailed description
Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.It will brought heavy burden to patients themselves,their family and society.Drugs,rehabilitation excise and hyperbaric oxygen will improve functions after acute stroke.However,in the chronic ischemic stroke,there was few methods to improve the functions.In recently research,stem cell will be a new methods to improve the neural function after through differentiate to nervous cells and secrete some neurotrophic factors to repair the damage. 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 ischemic stroke. The neurological outcome will be determined after transplantation.
- Conditions
- Stroke
- Being tested
- Intravenous stem cell transplantation
- Keywords
- Stroke, Bone Marrow Mesenchymal Stem Cell, Transplantation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous stem cell transplantationGenetic
Intravenous injection of autologous bone marrow mesenchymal stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| Intravenous stem cell transplantation | Active comparator | Intravenous transplantation of autologous bone marrow mesenchymal stem cell plus conventional treatment include rehabilitation Receives: Genetic: Intravenous 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 Fugl-Meyer Scale at 12 months
Measured: 1,3,6 and 12 months
Secondary outcomes (5)
Change from baseline in NIH Stroke Scale at 12 months
Measured: 1,3,6 and 12 months
Change from baseline in Barthel Index at 12 months
Measured: 1,3,6 and 12 months
Change from baseline in SSS at 12 months
Measured: 1,3,6 and 12 months
Change from baseline in mRS at 12 months
Measured: 1,3,6 and 12 months
Improvement of vision measured by brain visual examination
Measured: 1,6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2016 (estimated)
- Study completionNov 2017 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaodan Jiang, Southern Medical University, China
- Investigators
- Xiaodan Jiang, MD,PhD, Principal investigator, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564328
- Sponsor's protocol ID
- 201400000003-2
- Status last verified
- Sep 2015
- First submitted
- 29 Sep 2015
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02564328
- Acronym / sponsor ID
- 201400000003-2
- Conditions
- Stroke
- Keywords
- Stroke, Bone Marrow Mesenchymal Stem Cell, Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Southern Medical University, ChinaUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Guangzhou Medical University
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 30 Sep 2015 (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 a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.Stem cell transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy and safy of the transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.
Detailed description
Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.It will brought heavy burden to patients themselves,their family and society.Drugs,rehabilitation excise and hyperbaric oxygen will improve functions after acute stroke.However,in the chronic ischemic stroke,there was few methods to improve the functions.In recently research,stem cell will be a new methods to improve the neural function after through differentiate to nervous cells and secrete some neurotrophic factors to repair the damage. 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 ischemic stroke. The neurological outcome will be determined after transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous stem cell transplantation | Active comparator | Genetic: Intravenous stem cell transplantationIntravenous transplantation of autologous bone marrow mesenchymal stem cell plus conventional treatment include rehabilitation |
| Conventional treatment | No intervention | –Control group receive conventional stroke treatment that include rehabilitation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-80 chronic ischemia stroke or patients
- With stroke history of more than 6 months, less than 60 months
- NIHSS (NIH stroke scale) score of 7 or more points
- Internal carotid artery territory infarction measured by MRI
- Can be hospitalized and signed informed consent
Key exclusion criteria (8 listed)
- Lacunar infarction
- Recurrent thrombotic diseases less than 6 months
- Hemorrhage stroke,brain tumor or MRI show the occlusion is not in the middle cerebral artery territory
- Pregnant women
- Can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, AIDS, 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 |
|---|---|---|
| Intravenous stem cell transplantationIntravenous injection of autologous bone marrow mesenchymal stem cell transplantation | Genetic | Intravenous stem cell transplantation |
Primary outcome
Change from baseline in Fugl-Meyer Scale at 12 months
Time frame: 1,3,6 and 12 months
5 secondary outcomes
Change from baseline in NIH Stroke Scale at 12 months
Time frame: 1,3,6 and 12 months
Change from baseline in Barthel Index at 12 months
Time frame: 1,3,6 and 12 months
Change from baseline in SSS at 12 months
Time frame: 1,3,6 and 12 months
Change from baseline in mRS at 12 months
Time frame: 1,3,6 and 12 months
Improvement of vision measured by brain visual examination
Time frame: 1,6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Xiaodan Jiang, MD,PhD principal investigator
Southern Medical University, China
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 Intravenous stem cell transplantation in people with Stroke, run by Southern Medical University, China 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 6 inclusion and 8 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 30 Sep 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 Xiaodan Jiang, MD,PhD (86 20 61643268, jiangxiao_dan@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 Fugl-Meyer Scale at 12 months (time frame: 1,3,6 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 30 Sep 2015; AzTrials last refreshed its copy on 6 Nov 2026.