The Clinical Trial Research of Stem Cell Transplantation Treats Cerebral

NCT ID: NCT01389453

Last Updated: 2013-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-12-31

Brief Summary

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All experimental group patients of 100 patients accept a treatment course stem cell transplantation, including one time stem cell transplantation through intravenous injection way at the 10-21th day of cerebral hemorrhage, and the 7-14th day of cerebral infarction incidence; the second time transplantation through lumbar puncture way at the 7th day after the First time transplantation. The control group gives injection through intravenous and lumbar puncture ways separately in the corresponding time, but the transplantation matter is physiological saline not the stem cell.

Detailed Description

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The control group of 20 patients accept injection through intravenous and lumbar puncture ways separately in the corresponding time, but the transplantation matter is physiological saline not the stem cell.

Conditions

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Stroke

Keywords

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umbilical cord mesenchyma stem cell transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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stem cell transplatation

All experimental group patients accept a treatment course stem cell transplantation, including one time stem cell transplantation through intravenous injection way at the 10-21th day of cerebral hemorrhage, and the 7-14th day of cerebral infarction incidence; the second time transplantation through lumbar puncture way at the 7th day after the First time transplantation.

Group Type ACTIVE_COMPARATOR

stem cell transplantation

Intervention Type PROCEDURE

Patients accept a treatment course stem cell transplantation, including one time stem cell transplantation through intravenous injection way at the 10-21th day of cerebral hemorrhage, and the 7-14th day of cerebral infarction incidence; the second time transplantation through lumbar puncture way at the 7th day after the First time transplantation.

control

The control group gives injection through intravenous and lumbar puncture ways separately in the corresponding time, but the transplantation matter is physiological saline not the stem cell.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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stem cell transplantation

Patients accept a treatment course stem cell transplantation, including one time stem cell transplantation through intravenous injection way at the 10-21th day of cerebral hemorrhage, and the 7-14th day of cerebral infarction incidence; the second time transplantation through lumbar puncture way at the 7th day after the First time transplantation.

Intervention Type PROCEDURE

Other Intervention Names

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umbilical cord mesenchyma stem cell transplantation

Eligibility Criteria

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Inclusion Criteria

1. All tested patients with cerebral infarction, cerebral hemorrhage must tally with the diagnosis standard which in 1995 the Chinese fourth session of brain blood vessel of academic conference formulated, and after the head CT, MRI confirmation. All patients should be taken bad completely within for 24 hours.
2. patient's age and gender: 40-65years,the gender is not limit;
3. the hemorrhage, block region:One side basis festival area, one side brain stem;
4. the patient must catch the apoplexy at the first time and the accidence causes the obvious clinical symptoms.

Exclusion Criteria

1. Progressive apoplexy;
2. other internal organs strict illness sickness, like serious heart disease, diabetes, liver, kidney vigorous sickness and so on;
3. the patient with tumor in every system on there body;
4. Having the primary or the sequential epilepsy medical history, within one year had the epileptic paroxysm;
5. can not accept MRI inspection, for some metal implant in there body(such as inner support in heart or brain blood vessel).
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Chinese Armed Police Forces

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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An Yihua, doctor

Role: STUDY_DIRECTOR

Chinese People's Armed Police Force

Locations

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Yihua An

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2011-04-17 stroke

Identifier Type: -

Identifier Source: org_study_id