StrokePhase 2RecruitingNCT02580019
Umbilical Cord Derived Mesenchymal Stem Cells Treatment in Ischemic Stroke
A Phase 2 study testing Human umbilical cord mesenchymal stem cells in people with Stroke, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
The study aims at estimating the safety and efficacy of the intravenous injection of human umbilical cord mesenchymal stem cell(hUC-MSC) for patients suffering from ischemic stroke in recent 3 months. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Human umbilical cord mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Dec 2017
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of intracerebral ischemic stroke in three months by Magnetic Resonance Imaging(MRI)
- Patients have received proper treatment within two weeks from the onset of stroke symptoms.
- Age between 18 to 70 years old for men or women
- Patients with persistent neurological deficit .
- Obtaining informed consent signed (after being informed of the purpose, procedure, and venture of this study, the patient or guardian or legal representative must signing the informed consent document for engagement of participation.
- Patients basic situation are allowable to be involved in the program.
Who cannot join
- Patients with serious extensive stroke, who are unwilling to the risk.
- Patients with serious persistent neurological deficit (NIHSS > 24).
- Medical history of neurological pathology with a deficit as consequence (Rankin < 3 before stroke).
- Patients with serious psychological disease.
- Patients with myocardial infarction in recent 3 months.
- Patients with recurring thromboembolic disease in recentin recent 3 months.
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- Patients with organ transplantation.
- Patients with infection history including Human Immunodeficiency Virus(HIV),Human T-cell Leukemia Virus(HTLV), Hepatitis B Virus(HBV), Hepatitis C Virus(HCV),ect.
- Patients receive current immunosuppressive/immunomodulating treatment.
- Patients basic situation are unallowable to be involved in the program.
- Patients who refuse to participate.
- Patients who are inability or unwillingness of individual or legal guardian/representative to give written informed consent.
- Patients who are pregnant or feeding women.
- Patients who are Participating in another therapeutic clinical trial or in period of exclusion of a therapeutic clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurosurgery,Affiliated Hospital of Academy of Military Medical Sciences(307 Hospital)
Beijing, Beijing Municipality, 100071
About this study
Official title: Cell Therapy by Intravenous Injection of Umbilical Cord Derived Mesenchymal Stem Cells After Stroke
The study aims at estimating the safety and efficacy of the intravenous injection of human umbilical cord mesenchymal stem cell(hUC-MSC) for patients suffering from ischemic stroke in recent 3 months.
Read the detailed description
Given the attention paid in recent times, in China and elsewhere, to stroke, which is the leading cause of acquired adult disability and has negative effects on patients' quality of life.Therefore,It's little wonder there's much focus there days on treatment of stroke. For the patients who have suffered from ischemic stroke in 3 months, indeed, they have the opportunity to get symptomatic improvement through receiving conventional stroke treatments that including rehabilitation. At the same time, these treatments are ineffective in some cases. Alternatively, the phenomenon of increasing brain plasticity after stroke provoke an essential therapy. Human umbilical cord mesenchymal stem cells treatment enhances a functional improvement after cerebral ischemia, likewise, treament in rodent models are proved effective. Human umbilical cord mesenchymal stem cells therapy performs a role as take the place destroyed cerebral tissue with a stem cells graft. The totality of evidence from trials running umbilical cord mesenchymal stem cells transplanted into patients suffering from ischemic stroke support the safety of this approach. In terms of efficacy, positive results are reported in the majority of the trials.
Our research project involves a development of cell therapy in a phase IIa clinical trial of safety and efficacy in patients (randomised, controlled, open, with 2 parallel groups).
- Conditions
- Stroke
- Being tested
- Human umbilical cord mesenchymal stem cells
- Keywords
- Cellular therapy, Stroke, Neuronal Plasticity, Recovery, umbilical cord mesenchymal stem cells, Transplantation, Cardiovascular Diseases, Ischemia, Brain Infarction, Brain Ischemia, Cerebrovascular Disorders
- Medical subject headings
- Stroke, Cardiovascular Diseases, Ischemia, Brain Infarction, Brain Ischemia, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human umbilical cord mesenchymal stem cellsBiological
A single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.
| Study group | Role | What they receive |
|---|---|---|
| conventional stroke treatment | No intervention | Control group without intervention, whereas they receive conventional stroke treatment that including rehabilitation |
| hUC-MSC treatment | Experimental | Patients will receive human umbilical cord mesenchymal stem cells transplantation accompanied with conventional treatment including rehabilitation Receives: Biological: Human umbilical cord mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment related-adverse events during the study period.
Measured: 180 days after transfusion
Secondary outcomes (4)
Comparison of National Institutes of Health stroke scale (NIHSS).
Measured: 180 days after the cell treatment.
Comparison of modified Rankin scale (mRS).
Measured: 180 days after the cell treatment.
Distinguish of EuroQol 5d (EQ-5D) between pre- and post-treatment 180 days.
Measured: 180 days after the cell treatment.
Comparison of infarct size measured by brain MRI.
Measured: 180 days after the cell treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startFeb 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duan Lian, P.H.D, Principal investigator, Director and Professor, Department of Neurosurgery, Affiliated Hospital(307 Hospital), Academy of Military Medical Science, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580019
- Sponsor's protocol ID
- Hospital307
- Acronym
- Recruiting
- Status last verified
- Jul 2015
- First submitted
- 2 Jul 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cheng Q, Zhang Z, Zhang S, Yang H, Zhang X, Pan J, Weng L, Sha D, Zhu M, Hu X, Xu Y. Human umbilical cord mesenchymal stem cells protect against ischemic brain injury in mouse by regulating peripheral immunoinflammation. Brain Res. 2015 Jan 12;1594:293-304. doi: 10.1016/j.brainres.2014.10.065. Epub 2014 Nov 6.
PubMed 25449888Tsuji M, Taguchi A, Ohshima M, Kasahara Y, Sato Y, Tsuda H, Otani K, Yamahara K, Ihara M, Harada-Shiba M, Ikeda T, Matsuyama T. Effects of intravenous administration of umbilical cord blood CD34(+) cells in a mouse model of neonatal stroke. Neuroscience. 2014 Mar 28;263:148-58. doi: 10.1016/j.neuroscience.2014.01.018. Epub 2014 Jan 18.
PubMed 24444827Verina T, Fatemi A, Johnston MV, Comi AM. Pluripotent possibilities: human umbilical cord blood cell treatment after neonatal brain injury. Pediatr Neurol. 2013 May;48(5):346-54. doi: 10.1016/j.pediatrneurol.2012.10.010.
PubMed 23583051Yalvac ME, Rizvanov AA, Kilic E, Sahin F, Mukhamedyarov MA, Islamov RR, Palotas A. Potential role of dental stem cells in the cellular therapy of cerebral ischemia. Curr Pharm Des. 2009;15(33):3908-16. doi: 10.2174/138161209789649439.
PubMed 19938343
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell Therapy by Intravenous Injection of Umbilical Cord Derived Mesenchymal Stem Cells After Stroke
- ClinicalTrials.gov ID
- NCT02580019
- Acronym / sponsor ID
- Recruiting / Hospital307
- Conditions
- Stroke
- Keywords
- Cellular therapy, Stroke, Neuronal Plasticity, Recovery, umbilical cord mesenchymal stem cells, Transplantation, Cardiovascular Diseases, Ischemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 20 Oct 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.
The study aims at estimating the safety and efficacy of the intravenous injection of human umbilical cord mesenchymal stem cell(hUC-MSC) for patients suffering from ischemic stroke in recent 3 months.
Detailed description
Given the attention paid in recent times, in China and elsewhere, to stroke, which is the leading cause of acquired adult disability and has negative effects on patients' quality of life.Therefore,It's little wonder there's much focus there days on treatment of stroke. For the patients who have suffered from ischemic stroke in 3 months, indeed, they have the opportunity to get symptomatic improvement through receiving conventional stroke treatments that including rehabilitation. At the same time, these treatments are ineffective in some cases. Alternatively, the phenomenon of increasing brain plasticity after stroke provoke an essential therapy. Human umbilical cord mesenchymal stem cells treatment enhances a functional improvement after cerebral ischemia, likewise, treament in rodent models are proved effective. Human umbilical cord mesenchymal stem cells therapy performs a role as take the place destroyed cerebral tissue with a stem cells graft. The totality of evidence from trials running umbilical cord mesenchymal stem cells transplanted into patients suffering from ischemic stroke support the safety of this approach. In terms of efficacy, positive results are reported in the majority of the trials.
Our research project involves a development of cell therapy in a phase IIa clinical trial of safety and efficacy in patients (randomised, controlled, open, with 2 parallel groups).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional stroke treatment | No intervention | –Control group without intervention, whereas they receive conventional stroke treatment that including rehabilitation |
| hUC-MSC treatment | Experimental | Biological: Human umbilical cord mesenchymal stem cellsPatients will receive human umbilical cord mesenchymal stem cells transplantation accompanied with conventional treatment including rehabilitation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed diagnosis of intracerebral ischemic stroke in three months by Magnetic Resonance Imaging(MRI)
- Patients have received proper treatment within two weeks from the onset of stroke symptoms.
- Age between 18 to 70 years old for men or women
- Patients with persistent neurological deficit .
- Obtaining informed consent signed (after being informed of the purpose, procedure, and venture of this study, the patient or guardian or legal representative must signing the informed consent document for engagement of participation.
Key exclusion criteria (14 listed)
- Patients with serious extensive stroke, who are unwilling to the risk.
- Patients with serious persistent neurological deficit (NIHSS > 24).
- Medical history of neurological pathology with a deficit as consequence (Rankin < 3 before stroke).
- Patients with serious psychological disease.
- Patients with myocardial infarction in recent 3 months.
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 |
|---|---|---|
| Human umbilical cord mesenchymal stem cellsA single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times. | Biological | hUC-MSC treatment |
Primary outcome
Number of treatment related-adverse events during the study period.
Time frame: 180 days after transfusion
4 secondary outcomes
Comparison of National Institutes of Health stroke scale (NIHSS).
Time frame: 180 days after the cell treatment.
Comparison of modified Rankin scale (mRS).
Time frame: 180 days after the cell treatment.
Distinguish of EuroQol 5d (EQ-5D) between pre- and post-treatment 180 days.
Time frame: 180 days after the cell treatment.
Comparison of infarct size measured by brain MRI.
Time frame: 180 days after the cell treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Background: PubMed 25449888Cheng Q, Zhang Z, Zhang S, Yang H, Zhang X, Pan J, Weng L, Sha D, Zhu M, Hu X, Xu Y. Human umbilical cord mesenchymal stem cells protect against ischemic brain injury in mouse by regulating peripheral immunoinflammation. Brain Res. 2015 Jan 12;1594:293-304. doi: 10.1016/j.brainres.2014.10.065. Epub 2014 Nov 6.
- Background: PubMed 24444827Tsuji M, Taguchi A, Ohshima M, Kasahara Y, Sato Y, Tsuda H, Otani K, Yamahara K, Ihara M, Harada-Shiba M, Ikeda T, Matsuyama T. Effects of intravenous administration of umbilical cord blood CD34(+) cells in a mouse model of neonatal stroke. Neuroscience. 2014 Mar 28;263:148-58. doi: 10.1016/j.neuroscience.2014.01.018. Epub 2014 Jan 18.
- Background: PubMed 23583051Verina T, Fatemi A, Johnston MV, Comi AM. Pluripotent possibilities: human umbilical cord blood cell treatment after neonatal brain injury. Pediatr Neurol. 2013 May;48(5):346-54. doi: 10.1016/j.pediatrneurol.2012.10.010.
- Results publication: PubMed 19938343Yalvac ME, Rizvanov AA, Kilic E, Sahin F, Mukhamedyarov MA, Islamov RR, Palotas A. Potential role of dental stem cells in the cellular therapy of cerebral ischemia. Curr Pharm Des. 2009;15(33):3908-16. doi: 10.2174/138161209789649439.
- Human umbilical cord blood-derived mesenchymal stem cell transplantation attenuates severe brain injury by permanent middle cerebral artery occlusion in newborn ratsLink provided by the sponsor.
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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.
Duan Lian, P.H.D principal investigator
Director and Professor, Department of Neurosurgery, Affiliated Hospital(307 Hospital), Academy of Military Medical Science, Beijing, China
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 Human umbilical cord mesenchymal stem cells in people with Stroke, run by Affiliated Hospital to Academy of Military Medical Sciences 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 14 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 2 Dec 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 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 Li De Sheng, P.H.D (13811435365 ext. 011-86-126, deshengli301@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment related-adverse events during the study period. (time frame: 180 days after transfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02580019, which also lists 4 linked publications.
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 Dec 2015.