StrokePhase 2NCT00950521
Efficacy Study of CD34 Stem Cell in Chronic Stroke Patients
A Phase 2 study testing Intercerebral implantation of Autulogous Stem Cells and convention therapy in people with Stroke and Middle Cerebral Artery Infarction, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The objective of the study is to determine the efficacy of brain transplants of CD34+ stem cells obtained from peripheral blood of patients in the treatment of chronic stroke patients. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Stroke, Middle Cerebral Artery Infarction
- What is being tested?
- Intercerebral implantation of Autulogous Stem Cells and convention therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2009to Dec 2010
- Phase
- Phase 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 35-70 chronic stroke adult patient,
- with stroke history of more than 6 months, less than 60 months，
- with stable hemiplegia condition, and
- NIHSS (NIH Stroke Scale) score is between 9-20.
Who cannot join
- patients aged less than 35 or more than 70,
- hemorrhage stroke or MRI show the occlusion is not in the middle cerebral artery territory，NIHSS is not in the range of 9-20,
- pregnant women,
- impaired liver function, abnormal blood coagulation, AIDS, combine other tumor or special condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Autologous Peripheral Blood CD34 Stem Cell Implantation in Chronic Stroke Patients
The objective of the study is to determine the efficacy of brain transplants of CD34+ stem cells obtained from peripheral blood of patients in the treatment of chronic stroke patients.
Read the detailed description
30 patients are divided into 2 groups, one treatment group and one control group.Treatment group will be implanted with peripheral blood stem cell and receive convention stroke therapy ,and control group only receive convention stroke therapy. We expect that transplantation of the peripheral blood CD34+ cells has the potential of significant benefit to neurological recovery. In a previous phase I clinical trial, we have shown that transplantation of CD34+ cells obtained from the peripheral blood of the chronic stroke patients was safe and beneficial for neurological recovery. We expect this trial can further prove the efficacy of this treatment method.
- Conditions
- Stroke, Middle Cerebral Artery Infarction
- Being tested
- Intercerebral implantation of Autulogous Stem Cells, convention therapy
- Keywords
- Stroke, Stem Cell, Cell Therapy, CD34 Stem cell, Peripheral blood Stem cell
- 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.
Intercerebral implantation of Autulogous Stem CellsProcedure or surgery
Also called PBSC, CD34 Stem Cell
2-8 millions Stem cell per patients plus convention therapy
convention therapyDrug
antiplatelet
| Study group | Role | What they receive |
|---|---|---|
| PBSC Treatment | Active comparator | Patients in PBSC treatment will receive brain implant of autologous peripheral blood stem cell(CD34+) plus convention stroke treatment that include rehabilitation and antiplatelet medication Receives: Procedure: Intercerebral implantation of Autulogous Stem Cells |
| Control | Active comparator | Control group receive conventional stroke treatment that include rehabilitation and antiplatelet medication Receives: Drug: convention therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH-stroke scale (NIHSS)
Measured: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
Secondary outcomes (4)
European stroke scale (ESS)
Measured: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
European stroke motor subscale (EMS)
Measured: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
Barthel index and Mini-Mental State Examination (MMSE)
Measured: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
Magnetic resonance imaging (MRI) and computed tomography (CT) scans
Measured: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2010
- Study completionDec 2010
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.
- More trials run by China Medical University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shinn-Zong Lin, MD, DMSci, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950521
- Sponsor's protocol ID
- DMR-96-IRB-145
- Other IDs
- DOH Approval No:098004365
- Status last verified
- Apr 2011
- First submitted
- 30 Jul 2009
- Last updated
- 21 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mackie 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 21 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Autologous Peripheral Blood CD34 Stem Cell Implantation in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT00950521
- Acronym / sponsor ID
- DMR-96-IRB-145
- Conditions
- Stroke, Middle Cerebral Artery Infarction
- Keywords
- Stroke, Stem Cell, Cell Therapy, CD34 Stem cell, Peripheral blood Stem cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 31 Jul 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 objective of the study is to determine the efficacy of brain transplants of CD34+ stem cells obtained from peripheral blood of patients in the treatment of chronic stroke patients.
Detailed description
30 patients are divided into 2 groups, one treatment group and one control group.Treatment group will be implanted with peripheral blood stem cell and receive convention stroke therapy ,and control group only receive convention stroke therapy. We expect that transplantation of the peripheral blood CD34+ cells has the potential of significant benefit to neurological recovery. In a previous phase I clinical trial, we have shown that transplantation of CD34+ cells obtained from the peripheral blood of the chronic stroke patients was safe and beneficial for neurological recovery. We expect this trial can further prove the efficacy of this treatment method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBSC Treatment | Active comparator | Procedure: Intercerebral implantation of Autulogous Stem CellsPatients in PBSC treatment will receive brain implant of autologous peripheral blood stem cell(CD34+) plus convention stroke treatment that include rehabilitation and antiplatelet medication |
| Control | Active comparator | Drug: convention therapyControl group receive conventional stroke treatment that include rehabilitation and antiplatelet medication |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 35-70 chronic stroke adult patient,
- with stroke history of more than 6 months, less than 60 months，
- with stable hemiplegia condition, and
- NIHSS (NIH Stroke Scale) score is between 9-20.
Key exclusion criteria (4 listed)
- patients aged less than 35 or more than 70,
- hemorrhage stroke or MRI show the occlusion is not in the middle cerebral artery territory，NIHSS is not in the range of 9-20,
- pregnant women,
- impaired liver function, abnormal blood coagulation, AIDS, combine other tumor or special condition.
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 |
|---|---|---|
| Intercerebral implantation of Autulogous Stem CellsAlso: PBSC, CD34 Stem Cell2-8 millions Stem cell per patients plus convention therapy | Procedure or surgery | PBSC Treatment |
| convention therapyantiplatelet | Drug | Control |
Primary outcome
NIH-stroke scale (NIHSS)
Time frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
4 secondary outcomes
European stroke scale (ESS)
Time frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
European stroke motor subscale (EMS)
Time frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
Barthel index and Mini-Mental State Examination (MMSE)
Time frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
Magnetic resonance imaging (MRI) and computed tomography (CT) scans
Time frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
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 21 Apr 2011.
- 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.
Shinn-Zong Lin, MD, DMSci principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intercerebral implantation of Autulogous Stem Cells and convention therapy in people with Stroke and Middle Cerebral Artery Infarction, run by China Medical University Hospital at 1 site in Taiwan.
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 4 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 21 Apr 2011. 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 Taiwan. 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 phase mean?
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?
NIH-stroke scale (NIHSS) (time frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months). 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 NCT00950521, 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 21 Apr 2011.