The Clinical Trial Research of Stem Cell Transplantation Treats Cerebral

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01389453
• Other study ID #: 2011-04-17 stroke
• Status: Withdrawn
• Phase: Phase 2
• First received: July 6, 2011
• Last updated: February 26, 2013
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: October 2011
• Source: General Hospital of Chinese Armed Police Forces
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
China	Yihua An	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Chinese Armed Police Forces

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes