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The Clinical Trial Research of Stem Cell Transplantation Treats Cerebral

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

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01389453
Enrollment
0
Registered
2011-07-08
Start date
2011-04-30
Completion date
2012-12-31
Last updated
2013-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

umbilical cord mesenchyma stem cell transplantation

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.

Interventions

PROCEDUREstem 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.

Sponsors

General Hospital of Chinese Armed Police Forces
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
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).

Design outcomes

Primary

MeasureTime frameDescription
NIHSS and FIMbefore the transplant and after the transplant 1, 2 and 3 monthsAll 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

MeasureTime frameDescription
Motor evoked potential and sensation evoked potential inspectionbefore the transplant and after the transplant 0, 1, 3, 6 and 12 monthsAll 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 scanningbefore the transplant and after the transplant 0, 1, 3, 6 and 12 monthsAll 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;

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026