The Clinical Trial Research of Stem Cell Transplantation Treats Cerebral

• Sponsor: General Hospital of Chinese Armed Police Forces (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01389453
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Procedure: stem cell transplantation	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• 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
• Study Start Date: Apr 1, 2011
• Anticipated Primary Completion Date: Dec 1, 2011
• Anticipated Study Completion Date: Dec 1, 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. NIHSS and FIM [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

1. Motor evoked potential and sensation evoked potential inspection [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;

2. MRI+ DWI+ enhancement scanning [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;

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: General Hospital of Chinese Armed Police Forces
• ClinicalTrials.gov Identifier: NCT01389453
• Other Study ID Numbers: 2011-04-17 stroke
• First Posted: Jul 8, 2011
• Last Update Posted: Feb 28, 2013
• Last Verified: Oct 1, 2011

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

Study Results

No Results Posted as of Feb 28, 2013