Ischemic StrokePhase 1NCT01845350
Safety of Autologous M2 Macrophage in Treatment of Non-Acute Stroke Patients
A Phase 1 study testing M2 macrophage introduction in people with Ischemic Stroke and Hemorrhagic Stroke, run by Siberian Branch of the Russian Academy of Medical Sciences at 1 site in Russia.
Trial summary
The purpose of this study is to determine whether M2 macrophages are safe and feasible in the treatment of non-acute stroke patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Stroke, Hemorrhagic Stroke
- What is being tested?
- M2 macrophage introduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2012to Oct 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Computed tomography confirmed ischemic or hemorrhagic stroke
- Duration since stroke onset more than 3 and less than 12 months
- Age between 18 and 75 years old
- Persistent neurological deficits more than 4 points in NIHSS stroke scale
- Signed informed consent
Who cannot join
- The history of previous stroke
- Seizures
- Thrombophilias or primary hematological diseases
- Malignancy
- Hepatic or renal dysfunctions
- Hemodynamic or respiratory instability
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- Autoimmune disease
- HIV or uncontrolled bacterial, fungal, or viral infections
- Pregnancy
- Participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
Russia1 site
Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch)
Novosibirsk, 630099
About this study
Official title: Safety and Feasibility of Autologous M2 Macrophage Transplantation in Treatment of Non-Acute Stroke Patients
The purpose of this study is to determine whether M2 macrophages are safe and feasible in the treatment of non-acute stroke patients
Read the detailed description
Our primary hypothesis is that autologous M2 macrophage transplantation via intrathecal introduction is feasible and safe after non-acute stroke. Our secondary hypothesis is that autologous M2 macrophage transplantation is associated with improved neurological outcome after non-acute stroke
- Conditions
- Ischemic Stroke, Hemorrhagic Stroke
- Being tested
- M2 macrophage introduction
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M2 macrophage introductionOther
- Generation of autologous M2 macrophages from peripheral blood of non-acute stroke patients
- Intrathecal introduction of autologous M2 macrophages
| Study group | Role | What they receive |
|---|---|---|
| M2 macrophages | Other | M2 macrophage introduction Receives: Other: M2 macrophage introduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with severe adverse events
Occurence of severe adverse events including mortality, neurological worsening and seizures
Measured: 1-3 days, 6 months
Secondary outcomes (3)
Improvement of functional outcome in National Institutes of Health Stroke Scale (NIHSS)
Measured: 1-3 days, 6 months
Improvement in Barthel Index
Measured: 1-3 days, 6 months
Improvement in modified Rankin scale
Measured: 1-3 days, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startOct 2012
- Primary completionApr 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siberian Branch of the Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekaterina Y. Shevela, Siberian Branch of the Russian Academy of Medical Sciences
- Investigators
- Elena R. Chernykh, MD, PhD, Study chair, Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845350
- Sponsor's protocol ID
- STR-M2-2013
- Status last verified
- Nov 2016
- First submitted
- 24 Apr 2013
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Chernykh ER, Shevela EY, Starostina NM, Morozov SA, Davydova MN, Menyaeva EV, Ostanin AA. Safety and Therapeutic Potential of M2 Macrophages in Stroke Treatment. Cell Transplant. 2016;25(8):1461-71. doi: 10.3727/096368915X690279. Epub 2015 Dec 14.
PubMed 26671426
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Autologous M2 Macrophage Transplantation in Treatment of Non-Acute Stroke Patients
- ClinicalTrials.gov ID
- NCT01845350
- Acronym / sponsor ID
- STR-M2-2013
- Conditions
- Ischemic Stroke, Hemorrhagic Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Siberian Branch of the Russian Academy of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 3 May 2013 (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 purpose of this study is to determine whether M2 macrophages are safe and feasible in the treatment of non-acute stroke patients
Detailed description
Our primary hypothesis is that autologous M2 macrophage transplantation via intrathecal introduction is feasible and safe after non-acute stroke. Our secondary hypothesis is that autologous M2 macrophage transplantation is associated with improved neurological outcome after non-acute stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| M2 macrophages | Other | Other: M2 macrophage introductionM2 macrophage introduction |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Computed tomography confirmed ischemic or hemorrhagic stroke
- Duration since stroke onset more than 3 and less than 12 months
- Age between 18 and 75 years old
- Persistent neurological deficits more than 4 points in NIHSS stroke scale
- Signed informed consent
Key exclusion criteria (10 listed)
- The history of previous stroke
- Seizures
- Thrombophilias or primary hematological diseases
- Malignancy
- Hepatic or renal dysfunctions
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 |
|---|---|---|
| M2 macrophage introduction* Generation of autologous M2 macrophages from peripheral blood of non-acute stroke patients * Intrathecal introduction of autologous M2 macrophages | Other | M2 macrophages |
Primary outcome
The number of patients with severe adverse events
Time frame: 1-3 days, 6 months
Occurence of severe adverse events including mortality, neurological worsening and seizures
3 secondary outcomes
Improvement of functional outcome in National Institutes of Health Stroke Scale (NIHSS)
Time frame: 1-3 days, 6 months
Improvement in Barthel Index
Time frame: 1-3 days, 6 months
Improvement in modified Rankin scale
Time frame: 1-3 days, 6 months
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 4 Nov 2016.
- Results publication: PubMed 26671426Chernykh ER, Shevela EY, Starostina NM, Morozov SA, Davydova MN, Menyaeva EV, Ostanin AA. Safety and Therapeutic Potential of M2 Macrophages in Stroke Treatment. Cell Transplant. 2016;25(8):1461-71. doi: 10.3727/096368915X690279. Epub 2015 Dec 14.
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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.
Elena R. Chernykh, MD, PhD study chair
Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch)
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 M2 macrophage introduction in people with Ischemic Stroke and Hemorrhagic Stroke, run by Siberian Branch of the Russian Academy of Medical Sciences at 1 site in Russia.
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 10 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 4 Nov 2016. 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 Russia. 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?
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?
The number of patients with severe adverse events (time frame: 1-3 days, 6 months). 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 NCT01845350, which also lists 1 linked publication.
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 4 Nov 2016.