StrokePhase 1/2NCT02605707
Autologous Endothelial Progenitor Cells Transplantation for Chronic Ischemic Stroke
A Phase 1/2 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
- 12 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Feb 2020
- Phase
- Phase 1/2
- 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 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
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, 510282
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 endothelial progenitor 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 endothelial progenitor cells in patients with chronic ischemic stroke. The neurological outcome will be determined after transplantation.
- Conditions
- Stroke
- Being tested
- Intravenous stem cell transplantation
- Keywords
- Endothelial Progenitor Cells, Transplantation, Stroke
- 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 transplantationDrug
Intravenous injection of autologous endothelial progenitor cells transplantation
| Study group | Role | What they receive |
|---|---|---|
| Intravenous stem cell transplantation | Experimental | Intravenous transplantation of autologous endothelial progenitor cells plus conventional treatment include rehabilitation Receives: Drug: 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 24 months
Measured: 1,3,6,12 and 24months
Secondary outcomes (5)
Change from baseline in NIH Stroke Scale at 24 months
Measured: 1,3,6,12 and 24months
Change from baseline in Barthel Index at 24 months
Measured: 1,3,6,12 and 24months
Change from baseline in SSS at 24 months
Measured: 1,3,6,12 and 24months
Change from baseline in mRS at 24 months
Measured: 1,3,6,12 and 24months
Improvement of vision measured by brain visual examination
Measured: 1,3,6,12 and 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2017
- Study completionFeb 2020
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen-Zhou Chen, Southern Medical University, China
- Investigators
- ZhenZhou Chen, MD, phD, Principal investigator, Department of Neurosurgery, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605707
- Sponsor's protocol ID
- 2011Y1-00033-6
- Status last verified
- Apr 2021
- First submitted
- 12 Nov 2015
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Endothelial Progenitor Cells Transplantation for Chronic Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02605707
- Acronym / sponsor ID
- 2011Y1-00033-6
- Conditions
- Stroke
- Keywords
- Endothelial Progenitor Cells, Transplantation, Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Southern Medical University, ChinaUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Guangzhou Medical University
- Study start
- Nov 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 16 Nov 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 endothelial progenitor 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 endothelial progenitor 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 | Experimental | Drug: Intravenous stem cell transplantationIntravenous transplantation of autologous endothelial progenitor cells 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 endothelial progenitor cells transplantation | Drug | Intravenous stem cell transplantation |
Primary outcome
Change from baseline in Fugl-Meyer Scale at 24 months
Time frame: 1,3,6,12 and 24months
5 secondary outcomes
Change from baseline in NIH Stroke Scale at 24 months
Time frame: 1,3,6,12 and 24months
Change from baseline in Barthel Index at 24 months
Time frame: 1,3,6,12 and 24months
Change from baseline in SSS at 24 months
Time frame: 1,3,6,12 and 24months
Change from baseline in mRS at 24 months
Time frame: 1,3,6,12 and 24months
Improvement of vision measured by brain visual examination
Time frame: 1,3,6,12 and 24months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
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.
ZhenZhou Chen, MD, phD principal investigator
Department of Neurosurgery, Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 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: finished, as of the sponsor's last update on 2 Apr 2021. 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 combined 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Fugl-Meyer Scale at 24 months (time frame: 1,3,6,12 and 24months). 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 2 Apr 2021.