Ischemic StrokePhase 1/2SAMCISNCT01922908
Mesenchymal Stromal Cells for Ischemic Stroke
A Phase 1/2 study testing MSC Infusion in people with Ischemic Stroke, run by Sean Savitz.
Trial summary
The purpose of this study is to determine if mesenchymal stem cells given by IV is feasible and safe in patients with recent ischemic stroke and to decide the maximum tolerated dose when given between 3-10 days after an ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 83 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- MSC Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 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 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute ischemic stroke
- age 18 to 83 years
- post stroke mRS > 3
- NIHSS of 7-25
- Deficits on the total NIHSS can be lower than 7 provided the patients have moderate aphasia or visual loss (2 on the Best Language or Visual loss NIHSS subcomponent) *Criteria for mRS not used for this category of subjects
- Last seen normal st within 3-9 days prior to stroke. Time of onset for wake-up stroke will be defined as the time the patient woke up with symptoms.
- stem cell transplantation procedure must be performed between 3-10 days after stroke symptom onset
Who cannot join
- Ischemic stroke, primary hemorrhagic or traumatic lesion of the brain or myocardial infarction within past 30 days prior to current stroke.
- Mechanical heart valve
- Uncontrolled seizure disorder, defined as a seizure within the last 6 months
- Developmental delay
- Chronic kidney disease
- Hepatic disease or altered liver function
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- Pulmonary disease
- Cancer within 5 years prior to study
- Prior immunosuppression, including chemotherapy within last 3 years
- Known HIV
- Uncorrected coagulopathy or severe anemia
- Pregnancy
- Unable to undergo MRI or CT scan
- Imaging shows clinically significant hemorrhage
About this study
Official title: SAfety of Mesenchymal Stromal Cells for Ischemic Stroke
The purpose of this study is to determine if mesenchymal stem cells given by IV is feasible and safe in patients with recent ischemic stroke and to decide the maximum tolerated dose when given between 3-10 days after an ischemic stroke.
Read the detailed description
This is a randomized, double-blind, placebo controlled study. . Approximately 48 subjects will be enrolled in the trial, undergo a real or SHAM MSC IV infusion and will be follow out to 1 year. There will potentially be 4 Cohorts with the dose escalation at a 3:1 randomization schedule
Objectives:
- The primary hypothesis' are that intravenous administration of allogeneic bone marrow derived mesenchymal stem cells is feasible and safe in patients with recent ischemic stroke and to determine the maximum tolerated dose (MTD) of IV MSCs when administered sub-acutely between 3-10 days following ischemic stroke.
- The secondary hypothesis is that allogeneic MSC transplantation will improve functional outcome after recent ischemic stroke.
Safety and clinical efficacy points to be evaluated at Day 7 clinic visit, Day 30, Day 60, Day 90, and Day 180. Primary outcome or Primary endpoint of the study is to define the safety or harm of the MSCs
- Conditions
- Ischemic Stroke
- Being tested
- MSC Infusion, Placebo Comparator
- Keywords
- Ischemic, Stroke, Stem Cells, MSC, Allogeneic, Bone Marrow
- Medical subject headings
- Ischemic Stroke, Ischemia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSC InfusionBiological
Allogeneic bone marrow derived mesenchymal stem cells given in one dose 3-10 days after stroke symptom onset
Placebo ComparatorBiological
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| MSC infusion | Active comparator | Allogeneic bone marrow derived mesenchymal stem cells given in one dose 3-10 days after stroke symptom onset Receives: Biological: MSC Infusion |
| SHAM infusion | Placebo comparator | Infusion of normal saline placebo Receives: Biological: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerated dose (MTD) of IV MSCs
Measured: 24 hours
Secondary outcomes (1)
Improved functional outcome
as assessed by changes in mRS, NIHSS, Fugyl-Meyer and Barthel Index
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Plan to change the trial design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sean Savitz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sean Savitz, The University of Texas Health Science Center, Houston
- Investigators
- Sean Savitz, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922908
- Sponsor's protocol ID
- SAMCIS
- Acronym
- SAMCIS
- Status last verified
- Apr 2018
- First submitted
- 6 Aug 2013
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAfety of Mesenchymal Stromal Cells for Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01922908
- Acronym / sponsor ID
- SAMCIS / SAMCIS
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic, Stroke, Stem Cells, MSC, Allogeneic, Bone Marrow
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Plan to change the trial design
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sean SavitzUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 14 Aug 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 if mesenchymal stem cells given by IV is feasible and safe in patients with recent ischemic stroke and to decide the maximum tolerated dose when given between 3-10 days after an ischemic stroke.
Detailed description
This is a randomized, double-blind, placebo controlled study. . Approximately 48 subjects will be enrolled in the trial, undergo a real or SHAM MSC IV infusion and will be follow out to 1 year. There will potentially be 4 Cohorts with the dose escalation at a 3:1 randomization schedule
Objectives:
- The primary hypothesis' are that intravenous administration of allogeneic bone marrow derived mesenchymal stem cells is feasible and safe in patients with recent ischemic stroke and to determine the maximum tolerated dose (MTD) of IV MSCs when administered sub-acutely between 3-10 days following ischemic stroke.
- The secondary hypothesis is that allogeneic MSC transplantation will improve functional outcome after recent ischemic stroke.
Safety and clinical efficacy points to be evaluated at Day 7 clinic visit, Day 30, Day 60, Day 90, and Day 180. Primary outcome or Primary endpoint of the study is to define the safety or harm of the MSCs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSC infusion | Active comparator | Biological: MSC InfusionAllogeneic bone marrow derived mesenchymal stem cells given in one dose 3-10 days after stroke symptom onset |
| SHAM infusion | Placebo comparator | Biological: Placebo ComparatorInfusion of normal saline placebo |
Who may qualify
- Ages
- 18 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- acute ischemic stroke
- age 18 to 83 years
- post stroke mRS > 3
- NIHSS of 7-25
- Deficits on the total NIHSS can be lower than 7 provided the patients have moderate aphasia or visual loss (2 on the Best Language or Visual loss NIHSS subcomponent) *Criteria for mRS not used for this category of subjects
Key exclusion criteria (14 listed)
- Ischemic stroke, primary hemorrhagic or traumatic lesion of the brain or myocardial infarction within past 30 days prior to current stroke.
- Mechanical heart valve
- Uncontrolled seizure disorder, defined as a seizure within the last 6 months
- Developmental delay
- Chronic kidney disease
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 |
|---|---|---|
| MSC InfusionAllogeneic bone marrow derived mesenchymal stem cells given in one dose 3-10 days after stroke symptom onset | Biological | MSC infusion |
| Placebo ComparatorNormal saline | Biological | SHAM infusion |
Primary outcome
maximum tolerated dose (MTD) of IV MSCs
Time frame: 24 hours
1 secondary outcome
Improved functional outcome
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
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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.
Sean Savitz, MD principal investigator
The University of Texas Health Science Center, Houston
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MSC Infusion in people with Ischemic Stroke, run by Sean Savitz.
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 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: withdrawn, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
maximum tolerated dose (MTD) of IV MSCs (time frame: 24 hours). 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 18 Apr 2018.