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Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke (AHSCTIS)

Primary Purpose

Stroke

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
autologous hematopoiesis stem cell transplantation
Aspirin
Warfarin
Atorvastatin
Edaravone
Aspirin
Warfarin
Atorvastatin
Edaravone
Sponsored by
Zhejiang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, hematopoietic stem cell transplantation

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yaguo LiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

cell transplantation

Convention therapy

Arm Description

The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.

The control group just receive drug therapy.

Outcomes

Primary Outcome Measures

Change from Baseline in NIH-stroke scale (NIHSS) at 12 months

Secondary Outcome Measures

Barthel index
perfusion magnetic resonance imaging scan
Modified Rankin Scale(mRS)

Full Information

First Posted
January 10, 2012
Last Updated
January 24, 2012
Sponsor
Zhejiang Hospital
Collaborators
Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT01518231
Brief Title
Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke
Acronym
AHSCTIS
Official Title
Phase 1 Study of Autologous Peripheral Hematopoietic Stem Cell Transplantation in Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Hospital
Collaborators
Zhejiang University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, hematopoietic stem cell transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cell transplantation
Arm Type
Experimental
Arm Description
The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
Arm Title
Convention therapy
Arm Type
No Intervention
Arm Description
The control group just receive drug therapy.
Intervention Type
Procedure
Intervention Name(s)
autologous hematopoiesis stem cell transplantation
Intervention Description
Every participant will be transplanted with about 4 million autologous peripheral blood stem cell(CD34+) through cerebral artery.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
aspirin 100mg,qd,po(patients with no fibrillation atrial)
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
warfarin 2~6mg,qd,po(patients with fibrillation atrial);
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
atorvastatin 20mg,qd,po
Intervention Type
Drug
Intervention Name(s)
Edaravone
Intervention Description
edaravone 30mg,bid,ivgtt.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
aspirin 100mg,qd,po(patients with no fibrillation atrial)
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
warfarin 2~6mg,qd,po(patients with fibrillation atrial)
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
atorvastatin 20mg,qd,po
Intervention Type
Drug
Intervention Name(s)
Edaravone
Intervention Description
edaravone 30mg,bid,ivgtt
Primary Outcome Measure Information:
Title
Change from Baseline in NIH-stroke scale (NIHSS) at 12 months
Time Frame
1,3,6,12 months after cell transplantation
Secondary Outcome Measure Information:
Title
Barthel index
Time Frame
1,3,6,12 months after cell transplantation
Title
perfusion magnetic resonance imaging scan
Time Frame
1,3,6,12 months after cell transplantation
Title
Modified Rankin Scale(mRS)
Time Frame
3,6,12 months after cell transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yaguo Li, master
Phone
0086-0571-87987373
Ext
5103
Email
tjqlyg@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yumiao Zhou, master
Phone
0086-0571-87987373
Ext
5094
Email
zlf859@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaguo Li, master
Organizational Affiliation
Zhejiang Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yumiao Zhou, master
Organizational Affiliation
Zhejiang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yaguo Li
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yumiao Zhou, master
Phone
0086-0571-87987373
Ext
5094
Email
zlf859@yahoo.com.cn

12. IPD Sharing Statement

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Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke

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