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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier:
NCT01389453
First received: July 6, 2011
Last updated: February 26, 2013
Last verified: October 2011

July 6, 2011
February 26, 2013
April 2011
December 2011   (final data collection date for primary outcome measure)
NIHSS and FIM [ Time Frame: before the transplant and after the transplant 1, 2 and 3 months ] [ Designated as safety issue: Yes ]
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;
Same as current
Complete list of historical versions of study NCT01389453 on ClinicalTrials.gov Archive Site
  • Motor evoked potential and sensation evoked potential inspection [ Time Frame: before the transplant and after the transplant 0, 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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;
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Stroke
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
  • 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.
    Intervention: Procedure: 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2012
December 2011   (final data collection date for primary outcome measure)

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).
Both
40 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01389453
2011-04-17 stroke
Yes
General Hospital of Chinese Armed Police Forces
General Hospital of Chinese Armed Police Forces
Not Provided
Study Director: An Yihua, doctor Chinese People's Armed Police Force
General Hospital of Chinese Armed Police Forces
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP