Cerebral EmbolismPhase 1/2NCT01028794
Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients
A Phase 1/2 study testing autologous bone marrow mononuclear cells in people with Cerebral Embolism and Stroke, run by National Cerebral and Cardiovascular Center, Japan at 1 site in Japan.
Trial summary
The purpose of this study is to determine whether autologous bone marrow mononuclear cells transplantation after stroke is safe and/or effective to improve neurological outcome. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Cerebral Embolism, Stroke
- What is being tested?
- autologous bone marrow mononuclear cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteJapan
- Study dates
- May 2008to Jul 2013
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with cerebral embolism.
- NIHSS score is more than (or equal to) 10.
- On day 7 after onset of stroke, the improvement of NIHSS is less than (or equal to) 5, compared with the level at administration.
- Bone marrow aspiration can be done in 10 days after onset of stroke
Who cannot join
- Patient with cerebral hemorrhage or symptomatic hemorrhagic infarction.
- Patient who expects brain surgery.
- Patient with acute myocardial infarction.
- Patient with coagulation disorder.
- Number of Platelet < 100000/mm3
- Serum creatinine level >2.0mg/dl
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- Patient with malignancy.
- Patient with uncontrolled proliferative diabetic retinopathy.
- Patient suspected infective endocarditis.
- HBV, HCV, HIV or HTLV positive
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Cerebrovascular Disease, National Cardiovascular Center
Suita, Osaka, 565-8565
About this study
Official title: Phase 1/2A Study of Intravenous Autologous Bone Marrow Mononuclear Cell Transplantation for Patients After Cerebral Embolism
The purpose of this study is to determine whether autologous bone marrow mononuclear cells transplantation after stroke is safe and/or effective to improve neurological outcome.
- Conditions
- Cerebral Embolism, Stroke
- Being tested
- autologous bone marrow mononuclear cells
- Keywords
- stroke, bone marrow, mononuclear cell, angiogenesis, neurogenesis
- Medical subject headings
- Intracranial Embolism, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous bone marrow mononuclear cellsBiological
intravenous administration of autologous bone marrow derived mononuclear cells obtained from 25ml of bone marrow on day 7-10 after stroke (only once in that period)
autologous bone marrow mononuclear cellsBiological
intravenous administration of autologous bone marrow derived mononuclear cells obtained from 50ml of bone marrow on day 7-10 after stroke (only once in that period)
| Study group | Role | What they receive |
|---|---|---|
| autologous bone marrow mononuclear cell | Experimental | On day 7-10 after stroke, patient has 25ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously. Receives: Biological: autologous bone marrow mononuclear cells |
| autologous bone marrow mononuclear cells | Experimental | On day 7-10 after stroke, patient has 50ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously. Receives: Biological: autologous bone marrow mononuclear cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of NIHSS（National Institute of Health Stroke Scale）
Measured: 30 days after treatment
Frequency of change for the worse in NIHSS
Measured: 30 days aftrer treatment
Secondary outcomes (2)
Mean level of mRS (modified Rankin Scale)
Measured: 30 days after treatment
Frequency of death
Measured: day 30 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startMay 2008
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral EmbolismStudies 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
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cerebral and Cardiovascular Center, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan
- Responsible party
- Principal investigator, Akihiko Taguchi, National Cerebral and Cardiovascular Center, Japan
- Investigators
- Akihiko Taguchi, MD.PhD, Principal investigator, Department of Cerebrovascular Disease, National Cardiovascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028794
- Sponsor's protocol ID
- UMIN000001133
- Other IDs
- UMIN000001133
- Status last verified
- Jul 2013
- First submitted
- 8 Dec 2009
- Last updated
- 8 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Taguchi A, Soma T, Tanaka H, Kanda T, Nishimura H, Yoshikawa H, Tsukamoto Y, Iso H, Fujimori Y, Stern DM, Naritomi H, Matsuyama T. Administration of CD34+ cells after stroke enhances neurogenesis via angiogenesis in a mouse model. J Clin Invest. 2004 Aug;114(3):330-8. doi: 10.1172/JCI20622.
PubMed 15286799Taguchi A, Ohtani M, Soma T, Watanabe M, Kinosita N. Therapeutic angiogenesis by autologous bone-marrow transplantation in a general hospital setting. Eur J Vasc Endovasc Surg. 2003 Mar;25(3):276-8. doi: 10.1053/ejvs.2002.1831. No abstract available.
PubMed 12623341Taguchi A, Matsuyama T, Moriwaki H, Hayashi T, Hayashida K, Nagatsuka K, Todo K, Mori K, Stern DM, Soma T, Naritomi H. Circulating CD34-positive cells provide an index of cerebrovascular function. Circulation. 2004 Jun 22;109(24):2972-5. doi: 10.1161/01.CIR.0000133311.25587.DE. Epub 2004 Jun 7.
PubMed 15184275Taguchi A, Wen Z, Myojin K, Yoshihara T, Nakagomi T, Nakayama D, Tanaka H, Soma T, Stern DM, Naritomi H, Matsuyama T. Granulocyte colony-stimulating factor has a negative effect on stroke outcome in a murine model. Eur J Neurosci. 2007 Jul;26(1):126-33. doi: 10.1111/j.1460-9568.2007.05640.x.
PubMed 17614944
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2A Study of Intravenous Autologous Bone Marrow Mononuclear Cell Transplantation for Patients After Cerebral Embolism
- ClinicalTrials.gov ID
- NCT01028794
- Acronym / sponsor ID
- UMIN000001133
- Conditions
- Cerebral Embolism, Stroke
- Keywords
- stroke, bone marrow, mononuclear cell, angiogenesis, neurogenesis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Cerebral and Cardiovascular Center, JapanUniversity, hospital or other
- Collaborators
- Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan
- Study start
- May 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 9 Dec 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.
The purpose of this study is to determine whether autologous bone marrow mononuclear cells transplantation after stroke is safe and/or effective to improve neurological outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autologous bone marrow mononuclear cell | Experimental | Biological: autologous bone marrow mononuclear cellsOn day 7-10 after stroke, patient has 25ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously. |
| autologous bone marrow mononuclear cells | Experimental | Biological: autologous bone marrow mononuclear cellsOn day 7-10 after stroke, patient has 50ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with cerebral embolism.
- NIHSS score is more than (or equal to) 10.
- On day 7 after onset of stroke, the improvement of NIHSS is less than (or equal to) 5, compared with the level at administration.
- Bone marrow aspiration can be done in 10 days after onset of stroke
Key exclusion criteria (10 listed)
- Patient with cerebral hemorrhage or symptomatic hemorrhagic infarction.
- Patient who expects brain surgery.
- Patient with acute myocardial infarction.
- Patient with coagulation disorder.
- Number of Platelet < 100000/mm3
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 cellsintravenous administration of autologous bone marrow derived mononuclear cells obtained from 25ml of bone marrow on day 7-10 after stroke (only once in that period) | Biological | autologous bone marrow mononuclear cell |
| autologous bone marrow mononuclear cellsintravenous administration of autologous bone marrow derived mononuclear cells obtained from 50ml of bone marrow on day 7-10 after stroke (only once in that period) | Biological | autologous bone marrow mononuclear cells |
Primary outcome
Improvement of NIHSS（National Institute of Health Stroke Scale）
Time frame: 30 days after treatment
Frequency of change for the worse in NIHSS
Time frame: 30 days aftrer treatment
2 secondary outcomes
Mean level of mRS (modified Rankin Scale)
Time frame: 30 days after treatment
Frequency of death
Time frame: day 30 after treatment
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 8 Jul 2013.
- Background: PubMed 15286799Taguchi A, Soma T, Tanaka H, Kanda T, Nishimura H, Yoshikawa H, Tsukamoto Y, Iso H, Fujimori Y, Stern DM, Naritomi H, Matsuyama T. Administration of CD34+ cells after stroke enhances neurogenesis via angiogenesis in a mouse model. J Clin Invest. 2004 Aug;114(3):330-8. doi: 10.1172/JCI20622.
- Background: PubMed 12623341Taguchi A, Ohtani M, Soma T, Watanabe M, Kinosita N. Therapeutic angiogenesis by autologous bone-marrow transplantation in a general hospital setting. Eur J Vasc Endovasc Surg. 2003 Mar;25(3):276-8. doi: 10.1053/ejvs.2002.1831. No abstract available.
- Background: PubMed 15184275Taguchi A, Matsuyama T, Moriwaki H, Hayashi T, Hayashida K, Nagatsuka K, Todo K, Mori K, Stern DM, Soma T, Naritomi H. Circulating CD34-positive cells provide an index of cerebrovascular function. Circulation. 2004 Jun 22;109(24):2972-5. doi: 10.1161/01.CIR.0000133311.25587.DE. Epub 2004 Jun 7.
- Background: PubMed 17614944Taguchi A, Wen Z, Myojin K, Yoshihara T, Nakagomi T, Nakayama D, Tanaka H, Soma T, Stern DM, Naritomi H, Matsuyama T. Granulocyte colony-stimulating factor has a negative effect on stroke outcome in a murine model. Eur J Neurosci. 2007 Jul;26(1):126-33. doi: 10.1111/j.1460-9568.2007.05640.x.
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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.
Akihiko Taguchi, MD.PhD principal investigator
Department of Cerebrovascular Disease, National Cardiovascular Center
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 autologous bone marrow mononuclear cells in people with Cerebral Embolism and Stroke, run by National Cerebral and Cardiovascular Center, Japan at 1 site in Japan.
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 10 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 8 Jul 2013. 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 Japan. 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?
Improvement of NIHSS（National Institute of Health Stroke Scale） (time frame: 30 days after treatment). The study lists 2 primary outcomes in all. 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 NCT01028794, which also lists 4 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 8 Jul 2013.