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The Clinical Trial Research of Stem Cell Transplantation Treats Cerebral

This study has been withdrawn prior to enrollment.
(There were not enough number of patients recruited till DEC 31th in 2012.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01389453
First Posted: July 8, 2011
Last Update Posted: February 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
General Hospital of Chinese Armed Police Forces
  Purpose
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.

Condition Intervention Phase
Stroke Procedure: stem cell transplantation Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Umbilical Cord Mesenchyma Stem Cell Transplantation in Patients With Cerebral Hemorrhage and Cerebral Infarction

Resource links provided by NLM:


Further study details as provided by General Hospital of Chinese Armed Police Forces:

Primary Outcome Measures:
  • NIHSS and FIM [ Time Frame: before the transplant and after the transplant 1, 2 and 3 months ]
    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;


Secondary Outcome Measures:
  • Motor evoked potential and sensation evoked potential inspection [ Time Frame: before the transplant and after the transplant 0, 1, 3, 6 and 12 months ]
    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;

  • MRI+ DWI+ enhancement scanning [ Time Frame: before the transplant and after the transplant 0, 1, 3, 6 and 12 months ]
    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;


Enrollment: 0
Study Start Date: April 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01389453


Locations
China, Beijing
Yihua An
Beijing, Beijing, China, 100039
Sponsors and Collaborators
General Hospital of Chinese Armed Police Forces
Investigators
Study Director: An Yihua, doctor Chinese People's Armed Police Force
  More Information

Responsible Party: General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier: NCT01389453     History of Changes
Other Study ID Numbers: 2011-04-17 stroke
First Submitted: July 6, 2011
First Posted: July 8, 2011
Last Update Posted: February 28, 2013
Last Verified: October 2011

Keywords provided by General Hospital of Chinese Armed Police Forces:
umbilical cord mesenchyma stem cell transplantation