Stroke, AcutePhase 1/2NCT00761982
Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment.
A Phase 1/2 study testing Infusion on autologous CD34+ stem cells into middle cerebral artery in people with Stroke, Acute and Infarction, Middle Cerebral Artery, run by Hospital Universitario Central de Asturias at 2 sites in Spain.
Trial summary
The aim of the study is to determine the safety and efficacy on an autologous CD34+ subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute middle cerebral artery stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Acute, Infarction, Middle Cerebral Artery
- What is being tested?
- Infusion on autologous CD34+ stem cells into middle cerebral artery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSpain
- Study dates
- Sep 2008to Aug 2011
- 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
- Symptoms and signs of clinically definite middle cerebral artery acute stroke.
- Time of stroke onset is known and treatment can be started between day 5 and 9 of onset.
- DWI-MRI has reliably shown relevant acute ischemic lesions
- Extracranial duplex/transcranial Doppler must confirm intra/extracranial arteries permeability.
- The stroke is severe (NIH Stroke Scale >= 8 before procedure).
- An age range of 18-80 years old.
Who cannot join
- Patients out of inclusion age range.
- Lacunar infarction.
- Patients with cancer.
- Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma.
- Hematological causes of stroke.
- Severe co-morbidity.
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- Hepatic or renal dysfunction.
- The patient is female and of childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding.
- Patient is likely to be unavailable for follow-up.
- Patient with evidence of life threatening infection of life threatening illness.
- Patient was already dependent in activities of daily living before the present acute stroke.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33006
Hospitales Universitarios Virgen del Rocío
Seville, Andalusia
About this study
Official title: Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment
The aim of the study is to determine the safety and efficacy on an autologous CD34+ subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute middle cerebral artery stroke.
Read the detailed description
The proposed trial will involve the recruitment of a total of 20 patients.
The cells will be collected from ten subject recruited as cases, via bone marrow sampling. The aspirate will be centrifuged on a Ficoll density gradient to isolate mononuclear cells, which will be resuspended in heparinized isotonic saline for infusion into the area of the stroke intra-arterially using the middle cerebral artery.
The investigators will monitor each case and control for a period of 6 months post-stem cell infusion. Initially, they will be subjected to a review after one month,three months and finally 6 months.
Assessment of adverse events will be by physical examination and measurement of laboratory parameters. Assessment of efficacy will be by physical examination and the measurement of laboratory, CT and MRI parameters.
- Conditions
- Stroke, Acute, Infarction, Middle Cerebral Artery
- Being tested
- Infusion on autologous CD34+ stem cells into middle cerebral artery
- Medical subject headings
- Stroke, Infarction, Middle Cerebral Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion on autologous CD34+ stem cells into middle cerebral arteryProcedure or surgery
Intraarterial infusion of autologous bone marrow stem cells into middle cerebral artery of acute stroke patients
| Study group | Role | What they receive |
|---|---|---|
| bone marrow stem cells | Other | Procedure: Infusion of autologous CD34+ stem cells into middle cerebral artery. Receives: Procedure: Infusion on autologous CD34+ stem cells into middle cerebral artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of new neurological deficits and adverse effects during the timeframe.
Measured: Duration of study
Secondary outcomes (1)
Improvement in clinical function as assessed by the Modified Rankin Score, Barthel Scale and NIH stroke scale.
Measured: Duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Central de Asturias
- Sponsor type
- University, hospital or other
- Collaborators
- Hospitales Universitarios Virgen del Rocío
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761982
- Sponsor's protocol ID
- OVISEV-01
- Status last verified
- Nov 2011
- First submitted
- 28 Sep 2008
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Moniche F, Gonzalez A, Gonzalez-Marcos JR, Carmona M, Pinero P, Espigado I, Garcia-Solis D, Cayuela A, Montaner J, Boada C, Rosell A, Jimenez MD, Mayol A, Gil-Peralta A. Intra-arterial bone marrow mononuclear cells in ischemic stroke: a pilot clinical trial. Stroke. 2012 Aug;43(8):2242-4. doi: 10.1161/STROKEAHA.112.659409. Epub 2012 Jul 3.
PubMed 22764211Mackie AR, Losordo DW. CD34-positive stem cells: in the treatment of heart and vascular disease in human beings. Tex Heart Inst J. 2011;38(5):474-85.
PubMed 22163120
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment
- ClinicalTrials.gov ID
- NCT00761982
- Acronym / sponsor ID
- OVISEV-01
- Conditions
- Stroke, Acute, Infarction, Middle Cerebral Artery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Universitario Central de AsturiasUniversity, hospital or other
- Collaborators
- Hospitales Universitarios Virgen del Rocío
- Study start
- Sep 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 30 Sep 2008 (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 aim of the study is to determine the safety and efficacy on an autologous CD34+ subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute middle cerebral artery stroke.
Detailed description
The proposed trial will involve the recruitment of a total of 20 patients.
The cells will be collected from ten subject recruited as cases, via bone marrow sampling. The aspirate will be centrifuged on a Ficoll density gradient to isolate mononuclear cells, which will be resuspended in heparinized isotonic saline for infusion into the area of the stroke intra-arterially using the middle cerebral artery.
The investigators will monitor each case and control for a period of 6 months post-stem cell infusion. Initially, they will be subjected to a review after one month,three months and finally 6 months.
Assessment of adverse events will be by physical examination and measurement of laboratory parameters. Assessment of efficacy will be by physical examination and the measurement of laboratory, CT and MRI parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bone marrow stem cells | Other | Procedure: Infusion on autologous CD34+ stem cells into middle cerebral arteryProcedure: Infusion of autologous CD34+ stem cells into middle cerebral artery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Symptoms and signs of clinically definite middle cerebral artery acute stroke.
- Time of stroke onset is known and treatment can be started between day 5 and 9 of onset.
- DWI-MRI has reliably shown relevant acute ischemic lesions
- Extracranial duplex/transcranial Doppler must confirm intra/extracranial arteries permeability.
- The stroke is severe (NIH Stroke Scale >= 8 before procedure).
Key exclusion criteria (11 listed)
- Patients out of inclusion age range.
- Lacunar infarction.
- Patients with cancer.
- Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma.
- Hematological causes of stroke.
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 |
|---|---|---|
| Infusion on autologous CD34+ stem cells into middle cerebral arteryIntraarterial infusion of autologous bone marrow stem cells into middle cerebral artery of acute stroke patients | Procedure or surgery | bone marrow stem cells |
Primary outcome
Absence of new neurological deficits and adverse effects during the timeframe.
Time frame: Duration of study
1 secondary outcome
Improvement in clinical function as assessed by the Modified Rankin Score, Barthel Scale and NIH stroke scale.
Time frame: Duration of study
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 29 Nov 2011.
- Derived from this study: PubMed 22764211Moniche F, Gonzalez A, Gonzalez-Marcos JR, Carmona M, Pinero P, Espigado I, Garcia-Solis D, Cayuela A, Montaner J, Boada C, Rosell A, Jimenez MD, Mayol A, Gil-Peralta A. Intra-arterial bone marrow mononuclear cells in ischemic stroke: a pilot clinical trial. Stroke. 2012 Aug;43(8):2242-4. doi: 10.1161/STROKEAHA.112.659409. Epub 2012 Jul 3.
- Derived from this study: PubMed 22163120Mackie AR, Losordo DW. CD34-positive stem cells: in the treatment of heart and vascular disease in human beings. Tex Heart Inst J. 2011;38(5):474-85.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 Infusion on autologous CD34+ stem cells into middle cerebral artery in people with Stroke, Acute and Infarction, Middle Cerebral Artery, run by Hospital Universitario Central de Asturias at 2 sites in Spain.
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 11 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 29 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Absence of new neurological deficits and adverse effects during the timeframe. (time frame: Duration of study). 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 NCT00761982, which also lists 2 linked publications.
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 29 Nov 2011; AzTrials last refreshed its copy on 7 Nov 2026.