The Clinical Trial Research of Stem Cell Transplantation Treats Cerebral - Full Text View

Sponsor:	General Hospital of Chinese Armed Police Forces
Information provided by (Responsible Party):	General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier:	NCT01389453

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: 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:

Genetics Home Reference related topics: COL4A1-related brain small-vessel disease

U.S. FDA Resources

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 ] [ 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;

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 ] [ 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;

Estimated Enrollment:	120
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.

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

Ages Eligible for Study:	40 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
patient's age and gender: 40—65years，the gender is not limit;
the hemorrhage, block region：One side basis festival area, one side brain stem;
the patient must catch the apoplexy at the first time and the accidence causes the obvious clinical symptoms.

Exclusion Criteria:

Progressive apoplexy;
other internal organs strict illness sickness, like serious heart disease, diabetes, liver, kidney vigorous sickness and so on;
the patient with tumor in every system on there body;
Having the primary or the sequential epilepsy medical history, within one year had the epileptic paroxysm;
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389453

Contacts

Contact: An Yihua, doctor

0086-10-88276848

doctoran2010@hotmail.com

Locations

China, Beijing
Yihua An	Recruiting
Beijing, Beijing, China, 100039
Contact: An Yihua, doctor 0086-10-57976848 doctoran2010@hotmail.com

Sponsors and Collaborators

General Hospital of Chinese Armed Police Forces

Investigators

Study Director:

An Yihua, doctor

Chinese People's Armed Police Force

More Information

No publications provided

Responsible Party:	General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier:	NCT01389453 History of Changes
Other Study ID Numbers:	2011-04-17 stroke
Study First Received:	July 6, 2011
Last Updated:	October 7, 2011
Health Authority:	China: State Food and Drug Administration

Keywords provided by General Hospital of Chinese Armed Police Forces:

umbilical cord mesenchyma stem cell transplantation

Additional relevant MeSH terms:

Cerebral Hemorrhage
Cerebral Infarction
Stroke
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhage
Pathologic Processes
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 23, 2012