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Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke (AHSCTIS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Zhejiang Hospital.
Recruitment status was:  Recruiting
Zhejiang University
Information provided by (Responsible Party):
Yaguo Li, Zhejiang Hospital Identifier:
First received: January 10, 2012
Last updated: January 24, 2012
Last verified: January 2012
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
Procedure: autologous hematopoiesis stem cell transplantation
Drug: Aspirin
Drug: Warfarin
Drug: Atorvastatin
Drug: Edaravone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
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

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 ]

Secondary Outcome Measures:
  • 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 ]

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.

Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01518231

China, Zhejiang
Yaguo Li
Hangzhou, Zhejiang, China, 310013
Sponsors and Collaborators
Zhejiang Hospital
Zhejiang University
Study Director: Yaguo Li, master Zhejiang Hospital
Principal Investigator: Yumiao Zhou, master Zhejiang Hospital
  More Information

Responsible Party: Yaguo Li, Zhejiang Hospital Identifier: NCT01518231     History of Changes
Other Study ID Numbers: Zhejiang Hospital 
Study First Received: January 10, 2012
Last Updated: January 24, 2012

Keywords provided by Zhejiang Hospital:
hematopoietic stem cell transplantation

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Platelet Aggregation Inhibitors processed this record on February 20, 2017