Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke (AHSCTIS)
This study is currently recruiting participants.
Verified January 2012 by Zhejiang Hospital
Sponsor:
Zhejiang Hospital
Collaborator:
Zhejiang University
Information provided by (Responsible Party):
Yaguo Li, Zhejiang Hospital
ClinicalTrials.gov Identifier:
NCT01518231
First received: January 10, 2012
Last updated: January 24, 2012
Last verified: January 2012
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Purpose
The purpose of this study is to evaluate the safety and efficacy of autologous peripheral hematopoietic stem cell transplantation in ischemic stroke.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Procedure: autologous hematopoiesis stem cell transplantation Drug: Aspirin Drug: Warfarin Drug: Atorvastatin Drug: Edaravone |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 1 Study of Autologous Peripheral Hematopoietic Stem Cell Transplantation in Ischemic Stroke |
Resource links provided by NLM:
Further study details as provided by Zhejiang Hospital:
Primary Outcome Measures:
- Change from Baseline in NIH-stroke scale (NIHSS) at 12 months [ Time Frame: 1,3,6,12 months after cell transplantation ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Barthel index [ Time Frame: 1,3,6,12 months after cell transplantation ] [ Designated as safety issue: Yes ]
- perfusion magnetic resonance imaging scan [ Time Frame: 1,3,6,12 months after cell transplantation ] [ Designated as safety issue: Yes ]
- Modified Rankin Scale(mRS) [ Time Frame: 3,6,12 months after cell transplantation ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: cell transplantation
The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
|
Procedure: autologous hematopoiesis stem cell transplantation
Every participant will be transplanted with about 4 million autologous peripheral blood stem cell(CD34+) through cerebral artery.
Drug: Aspirin
aspirin 100mg,qd,po(patients with no fibrillation atrial)
Drug: Warfarin
warfarin 2~6mg,qd,po(patients with fibrillation atrial);
Drug: Atorvastatin
atorvastatin 20mg,qd,po
Drug: Edaravone
edaravone 30mg,bid,ivgtt.
|
|
No Intervention: Convention therapy
The control group just receive drug therapy.
|
Drug: Aspirin
aspirin 100mg,qd,po(patients with no fibrillation atrial)
Drug: Warfarin
warfarin 2~6mg,qd,po(patients with fibrillation atrial)
Drug: Atorvastatin
atorvastatin 20mg,qd,po
Drug: Edaravone
edaravone 30mg,bid,ivgtt
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518231
Contacts
| Contact: Yaguo Li, master | 0086-0571-87987373 ext 5103 | tjqlyg@163.com |
| Contact: Yumiao Zhou, master | 0086-0571-87987373 ext 5094 | zlf859@yahoo.com.cn |
Locations
| China, Zhejiang | |
| Yaguo Li | Recruiting |
| Hangzhou, Zhejiang, China, 310013 | |
| Contact: Yumiao Zhou, master 0086-0571-87987373 ext 5094 zlf859@yahoo.com.cn | |
Sponsors and Collaborators
Zhejiang Hospital
Zhejiang University
Investigators
| Study Director: | Yaguo Li, master | Zhejiang Hospital |
| Principal Investigator: | Yumiao Zhou, master | Zhejiang Hospital |
More Information
No publications provided
| Responsible Party: | Yaguo Li, Zhejiang Hospital |
| ClinicalTrials.gov Identifier: | NCT01518231 History of Changes |
| Other Study ID Numbers: | Zhejiang Hospital |
| Study First Received: | January 10, 2012 |
| Last Updated: | January 24, 2012 |
| Health Authority: | China: Science and Technology Department of Zhejiang Province |
Keywords provided by Zhejiang Hospital:
|
stroke hematopoietic stem cell transplantation |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Aspirin Atorvastatin Warfarin Phenylmethylpyrazolone Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013