Umbilical Cord Mesenchyma Stem Cell Transplantation in Patients With Cerebral Hemorrhage and Cerebral Infarction
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- NIHSS and FIM
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
NIHSS and FIM
Time Frame: 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 Outcomes
- Motor evoked potential and sensation evoked potential inspection(before the transplant and after the transplant 0, 1, 3, 6 and 12 months)
- MRI+ DWI+ enhancement scanning(before the transplant and after the transplant 0, 1, 3, 6 and 12 months)