The Clinical Trial Research of Stem Cell Transplantation Treats Cerebral

Umbilical Cord Mesenchyma Stem Cell Transplantation in Patients With Cerebral Hemorrhage and Cerebral Infarction

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.

Study Overview

• Status: Withdrawn
• Conditions: Stroke
• Intervention / Treatment: Procedure: stem cell transplantation

Detailed Description

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
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100039
      • Yihua An

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Procedure: 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.; Other Names: umbilical cord mesenchyma stem cell transplantation
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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;	before the transplant and after the transplant 1, 2 and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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;	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;	before the transplant and after the transplant 0, 1, 3, 6 and 12 months

Collaborators and Investigators

• Sponsor: General Hospital of Chinese Armed Police Forces
• Investigators: Study Director: An Yihua, doctor, Chinese People's Armed Police Force

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ANTICIPATED): December 1, 2011
• Study Completion (ANTICIPATED): December 1, 2012

Study Registration Dates

• First Submitted: July 6, 2011
• First Submitted That Met QC Criteria: July 7, 2011
• First Posted (ESTIMATE): July 8, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 28, 2013
• Last Update Submitted That Met QC Criteria: February 26, 2013
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: umbilical cord mesenchyma stem cell transplantation
• Other Study ID Numbers: 2011-04-17 stroke