Ischemic StrokePhase 1NCT01438593
Study of Purified Umbilical Cord Blood CD34+ Stem Cell on Chronic Ischemic Stroke
A Phase 1 study testing Intercerebral implantation of allogenic CD34+ stem cell in people with Ischemic Stroke and Ischaemic Cerebral Infarction, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The purpose of the study is to determine the safety and possible effectiveness of brain transplants of CD34+ stem cells obtained from umbilical cord blood (UCB) to treat stroke. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Ischemic Stroke, Ischaemic Cerebral Infarction, Infarction, Middle Cerebral Artery
- What is being tested?
- Intercerebral implantation of allogenic CD34+ stem cell
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2013to Dec 2013
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects can be of either gender and must be between 35 through 75 years of age.
- Subjects must have had ischemic stroke more than 6 and less than 60 months ago.
- Subjects must have stable hemiplegia or hemiparesis condition at least for 3 months.
- Subjects must have stroke-induced clinical deficits affecting motor, perceptual, or language functions, with a National Institutes of Health Stroke Scale (NIHSS) of 5-15.
- Subjects must have stroke in the middle cerebral artery territory.
- Subjects must have an available umbilical cord blood unit that has an HLA-match of at least 5:6 (HLA-A, -B, and -DR).
- Subjects must be able to read and understand the informed consent form that has been approved by the appropriate Institutional Review Board (IRB). The subject must sign and date the informed consent form before any study-specific procedures. (Note: If a subject consents to participation but is not in a position to sign and date the informed consent form personally because of his or her physical conditions, the consent form must be confirmed orally at the time of consent, marked or finger printed by the subject voluntarily). The informed consent procedure must be observed by an independent witness who is present throughout the whole informed consent process and sign the consent form.
Who cannot join
- Subject has evidence of a non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage or MRI has shown that the occlusion is not in the middle cerebral artery territory.
- Pregnant or lactating women.
- History of alcohol or drug abuse in the previous 3 months.
- Subjects must not have the following conditions in documents:
- significant renal, cardiovascular, hepatic, or psychiatric disease
- abnormal blood coagulation parameters,
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- immunodeficiency (e.g. AIDS)
- tumors, leukemia, and other cancer that may interfere with the clinical trial protocol
- infectious diseases, including hepatitis, or other conditions that may be a contraindication to the planned therapies and evaluation.
- Subject must not be currently participating in another investigational study or taking any investigational drug within the last four weeks before the screening of this study.
- Any other condition that, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol and would not be suitable to perform a surgery or to participate in the study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
China Medical University Hospital
Taichung, Taiwan, 244
Woei-Cherng Shyu, M.D.;PhD., 886-4-22052121 ext. 7813, shyu9423@gmail.com
Shinn-Zong Lin, M.D.;PhD.
About this study
Official title: An Exploratory Clinical Trial to Assess Treatment of Chronic Ischemic Stroke With Brain Transplants of Purified CD34+ Umbilical Cord Blood Stem Cells
The purpose of the study is to determine the safety and possible effectiveness of brain transplants of CD34+ stem cells obtained from umbilical cord blood (UCB) to treat stroke.
Read the detailed description
The study will use CD34+ cells (a special kind of cell that is believed to be a stem cell) isolated from UCB (blood obtained at birth from the umbilical cord blood of babies). StemCyte, a leading accredited UCB banking company with branches in the United States and Taiwan, will provide the units of UCB that match at least 5 out of 6 HLA (human leukocyte antigens) for transplantation. The HLA-matching is the same as that used to match cells and organs for transplantation so that the body does not reject the cells. We will isolate CD34 cells from these units, purified them, suspend the cells in solution (1 ml containing 2-8 million cells), and inject the cells into brain around the site damaged by the stroke
- Conditions
- Ischemic Stroke, Ischaemic Cerebral Infarction, Infarction, Middle Cerebral Artery, Ischemia, Brain Ischemia
- Being tested
- Intercerebral implantation of allogenic CD34+ stem cell
- Keywords
- Stroke, Brain disease, Ischemia, Cerebral infraction, Cord Blood
- Medical subject headings
- Ischemic Stroke, Infarction, Middle Cerebral Artery, Ischemia, Brain Ischemia, Stroke, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intercerebral implantation of allogenic CD34+ stem cellProcedure or surgery
Also called Hematopoietic stem cell, Cord Blood Stem Cell, UCB Stem Cell
Each patient will receive brain implant of approximately 5 million allogenic Umbilical cord blood CD34+ Stem Cell
| Study group | Role | What they receive |
|---|---|---|
| HUCB, Medicine, Rehabilitation | Experimental | Stroke patients are received intracerebral implantation of human cord blood stem cells (CD34+), Antiplatelet Medication, and Rehabilitation. Receives: Procedure: Intercerebral implantation of allogenic CD34+ stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in NIH Stroke Scale (NIHSS)
Evaluate change from Baseline in NIHSS at 1 week
Measured: Change from baseline in NIHSS at 1 weeks
Change from Baseline in NIH Stroke Scale(NIHSS)
Evaluate change from Baseline in NIHSS at 2 weeks
Measured: Change from Baseline in NIHSS at 2 weeks
Change from baseline in NIH Stroke Scale
Evaluate change from baseline in NIHSS at 4 weeks
Measured: Change from baseline in NIHSS at 4 weeks
Change from baseline in NIH Stroke Scale ( NIHSS)
Evaluate change from baseline in NIHSS at 12 weeks
Measured: Change from baseline in NIHSS at 12 weeks
Secondary outcomes (3)
Change from baseline in Brain Image
Brain Image will be performed by MRI. The MRI evaluation includes DEI, T1W, T2W, MRS, and DTI, and change from baseline will be evaluated at 1 week
Measured: Change from baseline in Brain Image at 1 week
Change from baseline in Brain Image
Brain Image will be performed by MRI. The MRI evaluation includes DEI,T1W,T2W,MRS and DTI , and evaluate the change from baseline at 4 weeks
Measured: Change from baseline in Brain Image at 4 weeks
Change from baseline in Brain Image
Brain Image will be performed by MRI.MRI image includes DEI,T1W, T2W, and DTI, and change from baseline will be evaluated at 6 months.
Measured: Change from baseline in Brain Image at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startJan 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
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 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shinn-Zong Lin, China Medical University Hospital
- Investigators
- Shinn-Zong Lin, M.D.;PhD., Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438593
- Sponsor's protocol ID
- DMR97-IRB-178-4
- Status last verified
- Dec 2011
- First submitted
- 7 Sep 2011
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Trial to Assess Treatment of Chronic Ischemic Stroke With Brain Transplants of Purified CD34+ Umbilical Cord Blood Stem Cells
- ClinicalTrials.gov ID
- NCT01438593
- Acronym / sponsor ID
- DMR97-IRB-178-4
- Conditions
- Ischemic Stroke, Ischaemic Cerebral Infarction, Infarction, Middle Cerebral Artery, Ischemia, Brain Ischemia
- Keywords
- Stroke, Brain disease, Ischemia, Cerebral infraction, Cord Blood
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 22 Sep 2011 (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 the study is to determine the safety and possible effectiveness of brain transplants of CD34+ stem cells obtained from umbilical cord blood (UCB) to treat stroke.
Detailed description
The study will use CD34+ cells (a special kind of cell that is believed to be a stem cell) isolated from UCB (blood obtained at birth from the umbilical cord blood of babies). StemCyte, a leading accredited UCB banking company with branches in the United States and Taiwan, will provide the units of UCB that match at least 5 out of 6 HLA (human leukocyte antigens) for transplantation. The HLA-matching is the same as that used to match cells and organs for transplantation so that the body does not reject the cells. We will isolate CD34 cells from these units, purified them, suspend the cells in solution (1 ml containing 2-8 million cells), and inject the cells into brain around the site damaged by the stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HUCB, Medicine, Rehabilitation | Experimental | Procedure: Intercerebral implantation of allogenic CD34+ stem cellStroke patients are received intracerebral implantation of human cord blood stem cells (CD34+), Antiplatelet Medication, and Rehabilitation. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects can be of either gender and must be between 35 through 75 years of age.
- Subjects must have had ischemic stroke more than 6 and less than 60 months ago.
- Subjects must have stable hemiplegia or hemiparesis condition at least for 3 months.
- Subjects must have stroke-induced clinical deficits affecting motor, perceptual, or language functions, with a National Institutes of Health Stroke Scale (NIHSS) of 5-15.
- Subjects must have stroke in the middle cerebral artery territory.
Key exclusion criteria (11 listed)
- Subject has evidence of a non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage or MRI has shown that the occlusion is not in the middle cerebral artery territory.
- Pregnant or lactating women.
- History of alcohol or drug abuse in the previous 3 months.
- Subjects must not have the following conditions in documents:
- Subject must not be currently participating in another investigational study or taking any investigational drug within the last four weeks before the screening of this study.
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 allogenic CD34+ stem cellAlso: Hematopoietic stem cell, Cord Blood Stem Cell, UCB Stem CellEach patient will receive brain implant of approximately 5 million allogenic Umbilical cord blood CD34+ Stem Cell | Procedure or surgery | HUCB, Medicine, Rehabilitation |
Primary outcome
Change from baseline in NIH Stroke Scale (NIHSS)
Time frame: Change from baseline in NIHSS at 1 weeks
Evaluate change from Baseline in NIHSS at 1 week
Change from Baseline in NIH Stroke Scale(NIHSS)
Time frame: Change from Baseline in NIHSS at 2 weeks
Evaluate change from Baseline in NIHSS at 2 weeks
Change from baseline in NIH Stroke Scale
Time frame: Change from baseline in NIHSS at 4 weeks
Evaluate change from baseline in NIHSS at 4 weeks
Change from baseline in NIH Stroke Scale ( NIHSS)
Time frame: Change from baseline in NIHSS at 12 weeks
Evaluate change from baseline in NIHSS at 12 weeks
3 secondary outcomes
Change from baseline in Brain Image
Time frame: Change from baseline in Brain Image at 1 week
Change from baseline in Brain Image
Time frame: Change from baseline in Brain Image at 4 weeks
Change from baseline in Brain Image
Time frame: Change from baseline in Brain Image at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
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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, M.D.;PhD. 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 1 study testing Intercerebral implantation of allogenic CD34+ stem cell in people with Ischemic Stroke and Ischaemic Cerebral 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 7 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: status not confirmed, as of the sponsor's last update on 2 Aug 2012. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Woei-Cherng Shyu, M.D.;PhD. (886-4-22052121 ext. 7813, Shyu9423@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in NIH Stroke Scale (NIHSS) (time frame: Change from baseline in NIHSS at 1 weeks). The study lists 4 primary outcomes in all. 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 2 Aug 2012.