Clinical trial NCT01389453: The Clinical Trial Research of Stem Cell Transplantation Treats Cerebral
Official title: Umbilical Cord Mesenchyma Stem Cell Transplantation in Patients With Cerebral Hemorrhage and Cerebral Infarction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Stroke
Keywords: umbilical cord mesenchyma stem cell transplantation
Lead sponsor: General Hospital of Chinese Armed Police Forces
Sponsor class: OTHER
First posted: 2011-07-08
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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 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).

Primary outcomes:
measure: NIHSS and FIM
timeFrame: before the transplant and after the transplant 1, 2 and 3 months
Secondary outcomes:
measure: Motor evoked potential and sensation evoked potential inspection
timeFrame: before the transplant and after the transplant 0, 1, 3, 6 and 12 months
measure: MRI+ DWI+ enhancement scanning
timeFrame: before the transplant and after the transplant 0, 1, 3, 6 and 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yihua An
state: Beijing
Study officials:
affiliation: Chinese People's Armed Police Force
name: An Yihua, doctor
role: STUDY_DIRECTOR
References: