Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke (AHSCTIS)

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Procedure: autologous hematopoiesis stem cell transplantation; Drug: Aspirin; Drug: Warfarin; Drug: Atorvastatin; Drug: Edaravone; Drug: Warfarin; Drug: Edaravone

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310013
      • Recruiting
      • Yaguo Li
      • Contact: Yumiao Zhou, master; Phone Number: 5094 0086-0571-87987373; Email: zlf859@yahoo.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Drug: Warfarin; warfarin 2~6mg,qd,po(patients with fibrillation atrial); 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.; Drug: Warfarin; warfarin 2~6mg,qd,po(patients with fibrillation atrial); Drug: Edaravone; edaravone 30mg,bid,ivgtt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in NIH-stroke scale (NIHSS) at 12 months	1,3,6,12 months after cell transplantation

Secondary Outcome Measures

Outcome Measure	Time Frame
Barthel index	1,3,6,12 months after cell transplantation
perfusion magnetic resonance imaging scan	1,3,6,12 months after cell transplantation
Modified Rankin Scale(mRS)	3,6,12 months after cell transplantation

Collaborators and Investigators

• Sponsor: Zhejiang Hospital
• Collaborators: Zhejiang University
• Investigators: Study Director: Yaguo Li, master, Zhejiang Hospital; Principal Investigator: Yumiao Zhou, master, Zhejiang Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2012
• Study Completion (ANTICIPATED): December 1, 2013

Study Registration Dates

• First Submitted: January 10, 2012
• First Submitted That Met QC Criteria: January 24, 2012
• First Posted (ESTIMATE): January 25, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 25, 2012
• Last Update Submitted That Met QC Criteria: January 24, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: stroke; hematopoietic stem cell transplantation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Antimetabolites; Neuroprotective Agents; Protective Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Anticoagulants; Antioxidants; Free Radical Scavengers; Aspirin; Atorvastatin; Edaravone; Warfarin
• Other Study ID Numbers: Zhejiang Hospital