Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke (AHSCTIS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Zhejiang Hospital.
Recruitment status was  Recruiting
Sponsor:
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
  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
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 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 September 18, 2014