Ischemic StrokePhase 1/2NCT01849887
Safety of Escalating Doses of Intravenous Bone Marrow-Derived Mesenchymal Stem Cells in Patients With a New Ischemic Stroke
A Phase 1/2 study testing bone marrow-derived mesenchymal stem cells in people with Ischemic Stroke, run by University of California, Irvine at 1 site in United States.
Trial summary
Stroke is a major cause of adult disability. Currently approved reperfusion therapies are provided to only a small percentage of patients in the U.S. New therapies are needed that improve outcome and that can be accessed by a majority of patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- bone marrow-derived mesenchymal stem cells
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jan 2016
- 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
- 1. Ischemic stroke in the middle cerebral artery territory, with onset 24-72 hours prior to the time that the therapy transfusion is initiated, radiologically confirmed, and with either diameter >15 mm or volume > 4cc.
- 2. The index stroke has clinical deficits that are moderate-severe (NIHSS score 7-20), did not require hemicraniectomy or invasive intracranial pressure monitoring, and was not associated with a concomitant STelevation myocardial infarction.
- 3. Age 18-80 years, inclusive
- 4. Reasonable likelihood of receiving standard post-stroke medical care, as well as standard physical, occupational, and speech therapy.
Who cannot join
- 1. No substantial pre-stroke disability (pre-stroke modified Rankin Scale score 0-2).
- 2. Females of child-bearing potential will be excluded unless (1) a negative urine pregnancy test is obtained and (2) the patient has been effectively using contraceptive method with known failure rate <1 % for at least 90 days.
- 3. Lactating mothers
- 4. If thrombolytic therapy has been administered, at least 24 hours have passed between completing thrombolytic dosing and initiating the current study's transfusion.
- 5. Known allergy to penicillin or to fetal bovine serum
- 6. Active co-existent major neurological or psychiatric disease that could significantly interfere with patient compliance or study assessments, including drug or alcohol abuse.
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- 7. Any diagnosis that makes survival to 1-year post-stroke unlikely.
- 8. Participation in any other experimental therapeutic clinical trial concurrently or in the prior three months.
- 9. Contraindication to undergoing MRI scanning.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Irvine Medical Center
Orange, California, 92868
About this study
Stroke is a major cause of adult disability. Currently approved reperfusion therapies are provided to only a small percentage of patients in the U.S. New therapies are needed that improve outcome and that can be accessed by a majority of patients. Animal studies suggest that bone marrow-derived mesenchymal stem cells, administered intravenously days after a stroke, safely improve long-term behavioral outcome. A large human experience suggests the safety of allogeneic bone marrow-derived mesenchymal stem cells. The current study aims to assess the safety of this therapy in patients with recent ischemic stroke.
- Conditions
- Ischemic Stroke
- Being tested
- bone marrow-derived mesenchymal stem cells, Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone marrow-derived mesenchymal stem cellsBiological
bone marrow-derived mesenchymal stem cells
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stem cells | Active comparator | bone marrow-derived mesenchymal stem cells Receives: Biological: bone marrow-derived mesenchymal stem cells |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: 1 month after transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startJan 2016
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Study was never started
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.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven C. Cramer, MD, University of California, Irvine
- Investigators
- Steve Cramer, MD, Principal investigator, Univ Calif Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849887
- Sponsor's protocol ID
- DR3-07521
- Status last verified
- Jan 2016
- First submitted
- 6 May 2013
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Escalating Doses of Intravenous Bone Marrow-Derived Mesenchymal Stem Cells in Patients With a New Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01849887
- Acronym / sponsor ID
- DR3-07521
- Conditions
- Ischemic Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 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.
Stroke is a major cause of adult disability. Currently approved reperfusion therapies are provided to only a small percentage of patients in the U.S. New therapies are needed that improve outcome and that can be accessed by a majority of patients. Animal studies suggest that bone marrow-derived mesenchymal stem cells, administered intravenously days after a stroke, safely improve long-term behavioral outcome. A large human experience suggests the safety of allogeneic bone marrow-derived mesenchymal stem cells. The current study aims to assess the safety of this therapy in patients with recent ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mesenchymal stem cells | Active comparator | Biological: bone marrow-derived mesenchymal stem cellsbone marrow-derived mesenchymal stem cells |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Ischemic stroke in the middle cerebral artery territory, with onset 24-72 hours prior to the time that the therapy transfusion is initiated, radiologically confirmed, and with either diameter >15 mm or volume > 4cc.
- 2. The index stroke has clinical deficits that are moderate-severe (NIHSS score 7-20), did not require hemicraniectomy or invasive intracranial pressure monitoring, and was not associated with a concomitant STelevation myocardial infarction.
- 3. Age 18-80 years, inclusive
- 4. Reasonable likelihood of receiving standard post-stroke medical care, as well as standard physical, occupational, and speech therapy.
Key exclusion criteria (9 listed)
- 1. No substantial pre-stroke disability (pre-stroke modified Rankin Scale score 0-2).
- 2. Females of child-bearing potential will be excluded unless (1) a negative urine pregnancy test is obtained and (2) the patient has been effectively using contraceptive method with known failure rate <1 % for at least 90 days.
- 3. Lactating mothers
- 4. If thrombolytic therapy has been administered, at least 24 hours have passed between completing thrombolytic dosing and initiating the current study's transfusion.
- 5. Known allergy to penicillin or to fetal bovine serum
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 |
|---|---|---|
| bone marrow-derived mesenchymal stem cellsbone marrow-derived mesenchymal stem cells | Biological | mesenchymal stem cells |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Number of Adverse Events
Time frame: 1 month after transfusion
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 22 Jan 2016.
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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.
Steve Cramer, MD principal investigator
Univ Calif Irvine
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 bone marrow-derived mesenchymal stem cells in people with Ischemic Stroke, run by University of California, Irvine at 1 site 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 4 inclusion and 9 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 22 Jan 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 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. 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?
Number of Adverse Events (time frame: 1 month after transfusion). 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 22 Jan 2016.