StrokePhase 1NCT00908856
Autologous Cell Therapy After Stroke
A Phase 1 study testing autologous bone marrow mononuclear cell transfusion and marrow stromal cells in people with Stroke, run by University of California, Irvine at 1 site in United States.
Trial summary
This study will examine the safety of two different cellular therapies in the treatment of stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- autologous bone marrow mononuclear cell transfusion and marrow stromal cells
- Type of treatment
- Injection or infusion
- 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 Dec 2017
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic stroke that is supratentorial in location and < 72 hours old between stroke onset and bone marrow aspiration
- No major pre-stroke disability
- NIH stroke scale score of 7-24
- Able to undergo bedside bone marrow aspiration
- Age 18-85 years, inclusive
- Reasonable likelihood of receiving standard physical, occupational and speech rehabilitation therapy
Who cannot join
- No major active hematological, immunological, or oncological diagnoses
- Pregnancy
- Lactating mothers
- At least 24 hours time of any thrombolytic therapy and time of bone marrow aspiration
- Allergy to penicillin or to fetal bovine serum
- Active, major co-existent neurological or psychiatric disease
Show all 9Show fewer
- Infection with HIV, hepatitis B or C, or syphilis
- Any diagnosis that makes survival to 90 days post-stroke unlikely
- Participation in an experimental therapeutic clinical trial in the prior three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of IV Autologous Mononuclear Cells and Marrow Stromal Cells After Stroke
This study will examine the safety of two different cellular therapies in the treatment of stroke.
Read the detailed description
Stroke remains a leading cause of death and disability. A limited number of therapies, such as intravenous tissue plasminogen activator, have been approved to interrupt stroke in the early hours after symptom onset. Many patients are not able to benefit from these therapies, however, and so a need exists for development of new interventions to reduce disability after stroke. This study will be an early step towards this, and will examine the safety of two cell types, mononuclear cells and marrow stromal cells. In each case, the cells will be autologous, specifically being derived from the subject's own bone marrow.
- Conditions
- Stroke
- Being tested
- autologous bone marrow mononuclear cell transfusion, marrow stromal cells, placebo
- Keywords
- stroke cell therapy repair autologous
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous bone marrow mononuclear cell transfusionBiological
Also called mononuclear cells
a single intravenous transfusion approximately 2 days after bone marrow aspiration, and 4 days after stroke onset; the full amount of autologous mononuclear cells derived from 30 cc of bone marrow
marrow stromal cellsBiological
Also called mesenchymal stromal cells
a single intravenous transfusion approximately 21 days after bone marrow aspiration, and 23 days after stroke onset; the full amount of marrow stromal cells cultured over 21 days from 30 cc of bone marrow (expected to be approximately 1,000,000 cells/kg body weight)
placeboDrug
a single intravenous transfusion of saline, approximately 2-21 days after bone marrow aspiration, and 4-23 days after stroke onset; the full amount of mononuclear cells derived from 30 cc of bone marrow
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: placebo |
| autologous mononuclear cells | Active comparator | a single intravenous autologous bone marrow mononuclear cell transfusion Receives: Biological: autologous bone marrow mononuclear cell transfusion |
| autologous marrow stromal cells | Active comparator | a single intravenous autologous marrow stromal cell transfusion Receives: Biological: marrow stromal cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
Measured: 90 days after stroke onset
Secondary outcomes (6)
myocardial infarction
Measured: 90 days after stroke onset
pulmonary embolism
Measured: 90 days after stroke onset
ischemic stroke
Measured: 90 days after stroke onset
deep venous thrombosis
Measured: 90 days after stroke onset
other arterial or venous thrombosis
Measured: 90 days after stroke onset
Infection requiring IV antibiotics
Measured: 90 days after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startJan 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Not funded
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 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
- 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
- Collaborators
- University of California, San Diego
- Responsible party
- Principal investigator, Steven C. Cramer, MD, University of California, Irvine
- Investigators
- Steven C. Cramer, MD, MMSc, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908856
- Sponsor's protocol ID
- 2003-3040
- Status last verified
- Feb 2016
- First submitted
- 26 May 2009
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lane TA, Garls D, Mackintosh E, Kohli S, Cramer SC. Liquid storage of marrow stromal cells. Transfusion. 2009 Jul;49(7):1471-81. doi: 10.1111/j.1537-2995.2009.02138.x. Epub 2009 Mar 31.
PubMed 19389020
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of IV Autologous Mononuclear Cells and Marrow Stromal Cells After Stroke
- ClinicalTrials.gov ID
- NCT00908856
- Acronym / sponsor ID
- 2003-3040
- Conditions
- Stroke
- Keywords
- stroke cell therapy repair autologous
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 27 May 2009 (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.
This study will examine the safety of two different cellular therapies in the treatment of stroke.
Detailed description
Stroke remains a leading cause of death and disability. A limited number of therapies, such as intravenous tissue plasminogen activator, have been approved to interrupt stroke in the early hours after symptom onset. Many patients are not able to benefit from these therapies, however, and so a need exists for development of new interventions to reduce disability after stroke. This study will be an early step towards this, and will examine the safety of two cell types, mononuclear cells and marrow stromal cells. In each case, the cells will be autologous, specifically being derived from the subject's own bone marrow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboPlacebo |
| autologous mononuclear cells | Active comparator | Biological: autologous bone marrow mononuclear cell transfusiona single intravenous autologous bone marrow mononuclear cell transfusion |
| autologous marrow stromal cells | Active comparator | Biological: marrow stromal cellsa single intravenous autologous marrow stromal cell transfusion |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ischemic stroke that is supratentorial in location and < 72 hours old between stroke onset and bone marrow aspiration
- No major pre-stroke disability
- NIH stroke scale score of 7-24
- Able to undergo bedside bone marrow aspiration
- Age 18-85 years, inclusive
Key exclusion criteria (9 listed)
- No major active hematological, immunological, or oncological diagnoses
- Pregnancy
- Lactating mothers
- At least 24 hours time of any thrombolytic therapy and time of bone marrow aspiration
- 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 |
|---|---|---|
| autologous bone marrow mononuclear cell transfusionAlso: mononuclear cellsa single intravenous transfusion approximately 2 days after bone marrow aspiration, and 4 days after stroke onset; the full amount of autologous mononuclear cells derived from 30 cc of bone marrow | Biological | autologous mononuclear cells |
| marrow stromal cellsAlso: mesenchymal stromal cellsa single intravenous transfusion approximately 21 days after bone marrow aspiration, and 23 days after stroke onset; the full amount of marrow stromal cells cultured over 21 days from 30 cc of bone marrow (expected to be approximately 1,000,000 cells/kg body weight) | Biological | autologous marrow stromal cells |
| placeboa single intravenous transfusion of saline, approximately 2-21 days after bone marrow aspiration, and 4-23 days after stroke onset; the full amount of mononuclear cells derived from 30 cc of bone marrow | Drug | Placebo |
Primary outcome
death
Time frame: 90 days after stroke onset
6 secondary outcomes
myocardial infarction
Time frame: 90 days after stroke onset
pulmonary embolism
Time frame: 90 days after stroke onset
ischemic stroke
Time frame: 90 days after stroke onset
deep venous thrombosis
Time frame: 90 days after stroke onset
other arterial or venous thrombosis
Time frame: 90 days after stroke onset
Infection requiring IV antibiotics
Time frame: 90 days after stroke onset
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 4 Feb 2016.
- Background: PubMed 19389020Lane TA, Garls D, Mackintosh E, Kohli S, Cramer SC. Liquid storage of marrow stromal cells. Transfusion. 2009 Jul;49(7):1471-81. doi: 10.1111/j.1537-2995.2009.02138.x. Epub 2009 Mar 31.
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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.
Steven C. Cramer, MD, MMSc principal investigator
University of California, 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 study testing autologous bone marrow mononuclear cell transfusion and marrow stromal cells in people with 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 6 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 4 Feb 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 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 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?
death (time frame: 90 days after stroke onset). 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 NCT00908856, 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 Feb 2016.