The Clinical Trial Research of Stem Cell Transplantation Treats Cerebral

General Hospital of Chinese Armed Police Forces

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Stroke

Interventions

stem cell transplantationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

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).

Locations (1)

Yihua An

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

NIHSS and FIM

All patients should receive the American State-run Health Research institute apoplexy meter (NIHSS)evaluation, the Fugl-Meyer evaluation, the function independence evaluation (FIM) separately before the transplant and after the transplant 1, 2 and 3 months , and the grading has the distinct improvement;

Time frame: before the transplant and after the transplant 1, 2 and 3 months

Secondary Outcomes

Motor evoked potential and sensation evoked potential inspection

All patients should be receive Motor evoked potential and sensation evoked potential inspection separately before the transplant and after the transplant 0, 1, 3, 6 and 12 months, and the function of movement and sensation get obvious improvement;

Time frame: before the transplant and after the transplant 0, 1, 3, 6 and 12 months

MRI+ DWI+ enhancement scanning

All patients should be receive cranial MRI+ DWI+ enhancement scanning separately before the transplant and after the transplant 0, 1, 3, 6 and 12 months, and the result tells us that there is obvious blood vessel proliferation on the surrounding of damaged region;

Time frame: before the transplant and after the transplant 0, 1, 3, 6 and 12 months

Data from ClinicalTrials.gov

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