Ischemic StrokePhase 1/2NCT01297413
A Study of Allogeneic Mesenchymal Bone Marrow Cells in Subjects With Ischemic Stroke
A Phase 1/2 study testing Allogeneic adult mesenchymal bone marrow stem cells in people with Ischemic Stroke, run by Stemedica Cell Technologies, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of allogeneic adult mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Allogeneic adult mesenchymal bone marrow stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2011to 15 Nov 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of ischemic stroke for longer than 6 months
- Brain CT/MRI scan at initial diagnosis and at enrollment consistent with ischemic stroke
- No substantial improvement in neurologic or functional deficits for the 2 months prior to enrollment
- NIHSS score between 6-20
- Life expectancy greater than 12 months
- Prior to treatment patient received standard medical care for the secondary prevention of ischemic stroke
- Adequate organ function as defined by the following criteria:
Who cannot join
- History of uncontrolled seizure disorder
- History of cancer within the past 5 years.
- History of cerebral neoplasm
- Positive for hepatitis B, C or HIV
- Myocardial infarction withing six months of study entry
- Findings on baseline CT suggestive of subarachnoid or intracerebral hemorrhage within past 12 months.
- Allergies to Bovine or Porcine products
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mercy Gilbert and Chandler Medical Center
Gilbert, Arizona, 85224
University of California Irvine Department of Neurology
Orange, California, 92868
University of California San Diego Division of Neurological Surgery
San Diego, California, 92123
About this study
Official title: A Phase I/II, Multi-Center, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Ischemic Stroke
The purpose of this study is to assess the safety and tolerability of allogeneic adult mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke.
Read the detailed description
Stroke remains a major global healthcare problem. Recent data compiled by the American Heart Association (AHA) for 2008 show that the annual incidence of new or recurrent stroke in the United States is about 780,000, with approximately 600,000 of these strokes being first attacks. Among adults age 20 and older, the estimated prevalence of stroke in 2005 was 5.8 million in the United States, resulting in >150,000 deaths annually, with 4.8 million stroke survivors alive today. Stroke ranks as the country's third leading cause of death, behind only cancer and heart disease. The only approved treatments of acute ischemic stroke involve restoring blood flow to the affected region by using thrombolytics or mechanical devices that physically remove clots. However, the use of thrombolytics is limited due to the therapeutic window of < 3-6 hours post onset of stroke symptoms such that only a small fraction of stroke patients receive this therapy. Following the completion of a stroke, there is little therapy to offer patients to promote recovery other than physical, occupational, and speech therapy.
Allogeneic mesenchymal stem cells have been used in a number of clinical trials for different indications demonstrated the safety of allogeneic mesenchymal stem cell treatment. In addition to their ability to differentiate into multiple different cell types that would be contributory to the recovery and repair of the brain by replacing destroyed cells, mesenchymal stem cells also secrete angiogenins, cytokines and trophic factors that can support and stimulate multiple other cell types. The cascade of cellular events following the release of these cytokines and trophic factors would also potentially lead to beneficial effects by restoring blood supply, by rescuing cells at risk, and by stimulating the remaining cell populations to repair and propagate new cells and synaptic connections.
- Conditions
- Ischemic Stroke
- Being tested
- Allogeneic adult mesenchymal bone marrow stem cells
- Keywords
- allogeneic, adult, stem, cells, stroke, ischemic
- Medical subject headings
- Ischemic Stroke, Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic adult mesenchymal bone marrow stem cellsBiological
Patients will receive intravenously one dose of 0.5-1.5 million cells per kg of allogeneic adult mesenchymal bone marrow stem cells
| Study group | Role | What they receive |
|---|---|---|
| Stem cells | Experimental | All subjects will receive allogeneic adult mesenchymal bone marrow stem cells Receives: Biological: Allogeneic adult mesenchymal bone marrow stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the safety of treatment with aMBMC during the twelve-month study period.
The primary endpoint will be the safety of treatment with aMBMC during the twelve-month study period as determined by the incidence and severity of adverse events, clinically-significant changes on clinical laboratory tests, vital signs, physical and neurologic examinations.
Measured: 12 month
Secondary outcomes (4)
National Institutes of Health Stroke Scale Score.
The change from the baseline in National Institutes of Health Stroke Scale score will be calculated at 1, 3, 6, 9, 12 months post-treatment, as available:
Measured: 12 months
Mini Mental Status Exam score.
The change from the baseline in Mini Mental Status Exam score will be calculated at 1, 3, 6, 9, 12 months post-treatment, as available.
Measured: 12 month
Barthel Index Score.
The change from the baseline in Barthel Index score at 1, 3, 6, 9, 12 months post-treatment, as available.
Measured: 12 month
The Geriatric Depression Scale Score.
The change from baseline in the Geriatric Depression Scale score at 1, 3, 6, 9, 12 months post-treatment, as available.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionSep 2017
- Study completion15 Nov 2018
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stemedica Cell Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego, Mercy Gilbert Medical Center at AZ, Chandler Regional Medical Center at Chandler AZ, UCI Medical Center
- Responsible party
- Sponsor
- Investigators
- Lev Verkh, PhD, Study director, Stemedica Cell Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297413
- Sponsor's protocol ID
- STEM 101-M
- Status last verified
- Nov 2018
- First submitted
- 10 Feb 2011
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Levy ML, Crawford JR, Dib N, Verkh L, Tankovich N, Cramer SC. Phase I/II Study of Safety and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Chronic Stroke. Stroke. 2019 Oct;50(10):2835-2841. doi: 10.1161/STROKEAHA.119.026318. Epub 2019 Sep 9.
PubMed 31495331
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Multi-Center, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01297413
- Acronym / sponsor ID
- STEM 101-M
- Conditions
- Ischemic Stroke
- Keywords
- allogeneic, adult, stem, cells, stroke, ischemic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Stemedica Cell Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego, Mercy Gilbert Medical Center at AZ, Chandler Regional Medical Center at Chandler AZ, UCI Medical Center
- Study start
- Feb 2011
- Primary completion
- Sep 2017 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 16 Feb 2011 (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 assess the safety and tolerability of allogeneic adult mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke.
Detailed description
Stroke remains a major global healthcare problem. Recent data compiled by the American Heart Association (AHA) for 2008 show that the annual incidence of new or recurrent stroke in the United States is about 780,000, with approximately 600,000 of these strokes being first attacks. Among adults age 20 and older, the estimated prevalence of stroke in 2005 was 5.8 million in the United States, resulting in >150,000 deaths annually, with 4.8 million stroke survivors alive today. Stroke ranks as the country's third leading cause of death, behind only cancer and heart disease. The only approved treatments of acute ischemic stroke involve restoring blood flow to the affected region by using thrombolytics or mechanical devices that physically remove clots. However, the use of thrombolytics is limited due to the therapeutic window of < 3-6 hours post onset of stroke symptoms such that only a small fraction of stroke patients receive this therapy. Following the completion of a stroke, there is little therapy to offer patients to promote recovery other than physical, occupational, and speech therapy.
Allogeneic mesenchymal stem cells have been used in a number of clinical trials for different indications demonstrated the safety of allogeneic mesenchymal stem cell treatment. In addition to their ability to differentiate into multiple different cell types that would be contributory to the recovery and repair of the brain by replacing destroyed cells, mesenchymal stem cells also secrete angiogenins, cytokines and trophic factors that can support and stimulate multiple other cell types. The cascade of cellular events following the release of these cytokines and trophic factors would also potentially lead to beneficial effects by restoring blood supply, by rescuing cells at risk, and by stimulating the remaining cell populations to repair and propagate new cells and synaptic connections.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem cells | Experimental | Biological: Allogeneic adult mesenchymal bone marrow stem cellsAll subjects will receive allogeneic adult mesenchymal bone marrow stem cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of ischemic stroke for longer than 6 months
- Brain CT/MRI scan at initial diagnosis and at enrollment consistent with ischemic stroke
- No substantial improvement in neurologic or functional deficits for the 2 months prior to enrollment
- NIHSS score between 6-20
- Life expectancy greater than 12 months
Key exclusion criteria (7 listed)
- History of uncontrolled seizure disorder
- History of cancer within the past 5 years.
- History of cerebral neoplasm
- Positive for hepatitis B, C or HIV
- Myocardial infarction withing six months of study entry
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 |
|---|---|---|
| Allogeneic adult mesenchymal bone marrow stem cellsPatients will receive intravenously one dose of 0.5-1.5 million cells per kg of allogeneic adult mesenchymal bone marrow stem cells | Biological | Stem cells |
Primary outcome
The primary endpoint will be the safety of treatment with aMBMC during the twelve-month study period.
Time frame: 12 month
The primary endpoint will be the safety of treatment with aMBMC during the twelve-month study period as determined by the incidence and severity of adverse events, clinically-significant changes on clinical laboratory tests, vital signs, physical and neurologic examinations.
4 secondary outcomes
National Institutes of Health Stroke Scale Score.
Time frame: 12 months
Mini Mental Status Exam score.
Time frame: 12 month
Barthel Index Score.
Time frame: 12 month
The Geriatric Depression Scale Score.
Time frame: 12 month
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 3 Dec 2018.
- Derived from this study: PubMed 31495331Levy ML, Crawford JR, Dib N, Verkh L, Tankovich N, Cramer SC. Phase I/II Study of Safety and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Chronic Stroke. Stroke. 2019 Oct;50(10):2835-2841. doi: 10.1161/STROKEAHA.119.026318. Epub 2019 Sep 9.
Related trials for Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
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.
Lev Verkh, PhD study director
Stemedica Cell Technologies, Inc.
3 sites 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 Allogeneic adult mesenchymal bone marrow stem cells in people with Ischemic Stroke, run by Stemedica Cell Technologies, Inc. at 3 sites in United States.
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 7 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: finished, as of the sponsor's last update on 3 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The primary endpoint will be the safety of treatment with aMBMC during the twelve-month study period. (time frame: 12 month). 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 NCT01297413, 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 3 Dec 2018.