StrokePhase 1AHSCTISNCT01518231
Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke
A Phase 1 study testing autologous hematopoiesis stem cell transplantation, Aspirin and Warfarin in people with Stroke, run by Zhejiang Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of autologous peripheral hematopoietic stem cell transplantation in ischemic stroke. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- autologous hematopoiesis stem cell transplantation, Aspirin and Warfarin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 40~70
- no consciousness disorders
- internal carotid artery territory infarction
- stroke happened < 1 year
- with stable hemiplegia, but remain dependent in daily life
- SSS(Scandinavian Stroke Scale) < 40
Who cannot join
- pregnant women
- can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, AIDS, combine other tumor or special condition
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yaguo Li
Hangzhou, Zhejiang, 310013
Yumiao Zhou, master, 0086-0571-87987373 ext. 5094, zlf859@yahoo.com.cn
About this study
Official title: Phase 1 Study of Autologous Peripheral Hematopoietic Stem Cell Transplantation in Ischemic Stroke
The purpose of this study is to evaluate the safety and efficacy of autologous peripheral hematopoietic stem cell transplantation in ischemic stroke.
Read the detailed description
Stroke is among the main causes of mortality and disability of elderly population which still lack of efficient therapy. Stem sell transplantation provides a functional improvement after cerebral ischemia in rat models. Our study will recruit 40 ischemic stroke patients which will be divided into 2 groups (20 patients each): treatment group and control group. The former will be implanted with peripheral blood stem cell through anterior cerebral artery or middle cerebral artery (determined by the section of infarction) and receive convention stroke therapy. The latter only receive convention stroke therapy. The investigators expect that transplantation of the peripheral hematopoietic stem cell is safe and efficient to neurological recovery.
- Conditions
- Stroke
- Being tested
- autologous hematopoiesis stem cell transplantation, Aspirin, Warfarin, Atorvastatin, Edaravone
- Keywords
- stroke, hematopoietic stem cell transplantation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous hematopoiesis stem cell transplantationProcedure or surgery
Every participant will be transplanted with about 4 million autologous peripheral blood stem cell(CD34+) through cerebral artery.
AspirinDrug
aspirin 100mg,qd,po(patients with no fibrillation atrial)
WarfarinDrug
warfarin 2~6mg,qd,po(patients with fibrillation atrial);
AtorvastatinDrug
atorvastatin 20mg,qd,po
EdaravoneDrug
edaravone 30mg,bid,ivgtt.
AspirinDrug
aspirin 100mg,qd,po(patients with no fibrillation atrial)
WarfarinDrug
warfarin 2~6mg,qd,po(patients with fibrillation atrial)
AtorvastatinDrug
atorvastatin 20mg,qd,po
EdaravoneDrug
edaravone 30mg,bid,ivgtt
| Study group | Role | What they receive |
|---|---|---|
| cell transplantation | Experimental | The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy. Receives: Procedure: autologous hematopoiesis stem cell transplantation; Drug: Aspirin; Drug: Warfarin; Drug: Atorvastatin; Drug: Edaravone |
| Convention therapy | No intervention | The control group just receive drug therapy. Receives: Drug: Aspirin; Drug: Warfarin; Drug: Atorvastatin; Drug: Edaravone |
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) at 12 months
Measured: 1,3,6,12 months after cell transplantation
Secondary outcomes (3)
Barthel index
Measured: 1,3,6,12 months after cell transplantation
perfusion magnetic resonance imaging scan
Measured: 1,3,6,12 months after cell transplantation
Modified Rankin Scale(mRS)
Measured: 3,6,12 months after cell transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2012 (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 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University
- Responsible party
- Principal investigator, Yaguo Li, Zhejiang Hospital
- Investigators
- Yaguo Li, master, Study director, Zhejiang HospitalYumiao Zhou, master, Principal investigator, Zhejiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518231
- Sponsor's protocol ID
- Zhejiang Hospital
- Acronym
- AHSCTIS
- Status last verified
- Jan 2012
- First submitted
- 10 Jan 2012
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Autologous Peripheral Hematopoietic Stem Cell Transplantation in Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01518231
- Acronym / sponsor ID
- AHSCTIS / Zhejiang Hospital
- Conditions
- Stroke
- Keywords
- stroke, hematopoietic stem cell transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhejiang HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 25 Jan 2012 (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 evaluate the safety and efficacy of autologous peripheral hematopoietic stem cell transplantation in ischemic stroke.
Detailed description
Stroke is among the main causes of mortality and disability of elderly population which still lack of efficient therapy. Stem sell transplantation provides a functional improvement after cerebral ischemia in rat models. Our study will recruit 40 ischemic stroke patients which will be divided into 2 groups (20 patients each): treatment group and control group. The former will be implanted with peripheral blood stem cell through anterior cerebral artery or middle cerebral artery (determined by the section of infarction) and receive convention stroke therapy. The latter only receive convention stroke therapy. The investigators expect that transplantation of the peripheral hematopoietic stem cell is safe and efficient to neurological recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cell transplantation | Experimental | Procedure: autologous hematopoiesis stem cell transplantation, Drug: Aspirin, Drug: Warfarin, Drug: Atorvastatin, Drug: EdaravoneThe study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy. |
| Convention therapy | No intervention | Drug: Aspirin, Drug: Warfarin, Drug: Atorvastatin, Drug: EdaravoneThe control group just receive drug therapy. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged 40~70
- no consciousness disorders
- internal carotid artery territory infarction
- stroke happened < 1 year
- with stable hemiplegia, but remain dependent in daily life
Key exclusion criteria (2 listed)
- pregnant women
- can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, 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 |
|---|---|---|
| autologous hematopoiesis stem cell transplantationEvery participant will be transplanted with about 4 million autologous peripheral blood stem cell(CD34+) through cerebral artery. | Procedure or surgery | cell transplantation |
| Aspirinaspirin 100mg,qd,po(patients with no fibrillation atrial) | Drug | cell transplantation |
| Warfarinwarfarin 2~6mg,qd,po(patients with fibrillation atrial); | Drug | cell transplantation |
| Atorvastatinatorvastatin 20mg,qd,po | Drug | cell transplantation |
| Edaravoneedaravone 30mg,bid,ivgtt. | Drug | cell transplantation |
| Aspirinaspirin 100mg,qd,po(patients with no fibrillation atrial) | Drug | Convention therapy |
| Warfarinwarfarin 2~6mg,qd,po(patients with fibrillation atrial) | Drug | Convention therapy |
| Atorvastatinatorvastatin 20mg,qd,po | Drug | Convention therapy |
| Edaravoneedaravone 30mg,bid,ivgtt | Drug | Convention therapy |
Primary outcome
Change from Baseline in NIH-stroke scale (NIHSS) at 12 months
Time frame: 1,3,6,12 months after cell transplantation
3 secondary outcomes
Barthel index
Time frame: 1,3,6,12 months after cell transplantation
perfusion magnetic resonance imaging scan
Time frame: 1,3,6,12 months after cell transplantation
Modified Rankin Scale(mRS)
Time frame: 3,6,12 months after cell transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 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.
Yaguo Li, master study director
Zhejiang Hospital
Yumiao Zhou, master principal investigator
Zhejiang 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 autologous hematopoiesis stem cell transplantation, Aspirin and Warfarin in people with Stroke, run by Zhejiang Hospital at 1 site in China.
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 2 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 25 Jan 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 China. 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 Yaguo Li, master (0086-0571-87987373 ext. 5103, tjqlyg@163.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) at 12 months (time frame: 1,3,6,12 months after cell transplantation). 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 25 Jan 2012.