The Clinical Trial Research of Stem Cell Transplantation Treats Cerebral

Withdrawn

Phase 2 Results N/A

Trial Description

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.

Trial Stopped: There were not enough number of patients recruited till DEC 31th in 2012.

Conditions

Interventions

  • Stem cell transplantation Procedure
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: stem cell transplatation
    Description: 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.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Factorial Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary NIHSS and FIM before the transplant and after the transplant 1, 2 and 3 months Yes
Secondary Motor evoked potential and sensation evoked potential inspection before the transplant and after the transplant 0, 1, 3, 6 and 12 months Yes
Secondary MRI+ DWI+ enhancement scanning before the transplant and after the transplant 0, 1, 3, 6 and 12 months Yes

Sponsors