Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke "AHSCTIS"

Recruiting

Phase 1 Results N/A

Trial Description

The purpose of this study is to evaluate the safety and efficacy of autologous peripheral hematopoietic stem cell transplantation in ischemic stroke.

Detailed Description

Stroke is among the main causes of mortality and disability of elderly population which still lack of efficient therapy. Stem sell transplantation provides a functional improvement after cerebral ischemia in rat models. Our study will recruit 40 ischemic stroke patients which will be divided into 2 groups (20 patients each): treatment group and control group. The former will be implanted with peripheral blood stem cell through anterior cerebral artery or middle cerebral artery (determined by the section of infarction) and receive convention stroke therapy. The latter only receive convention stroke therapy. The investigators expect that transplantation of the peripheral hematopoietic stem cell is safe and efficient to neurological recovery.

Conditions

Interventions

  • Warfarin (CoumadinĀ®)Drug
    Other Names: Coumadin; Acenocoumarol
    Intervention Desc: warfarin 2~6mg,qd,po(patients with fibrillation atrial)
    ARM 1: Kind: Experimental
    Label: cell transplantation
    Description: The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
    ARM 2: Kind: Experimental
    Label: Convention therapy
    Description: The control group just receive drug therapy.
  • Atorvastatin (LipitorĀ®)Drug
    Other Names: Lipitor
    Intervention Desc: atorvastatin 20mg,qd,po
    ARM 1: Kind: Experimental
    Label: cell transplantation
    Description: The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
    ARM 2: Kind: Experimental
    Label: Convention therapy
    Description: The control group just receive drug therapy.
  • Edaravone (3-methyl-1-phenyl-2-pyrazolin-5-one)Drug
    Other Names: Radicut
    Intervention Desc: edaravone 30mg,bid,ivgtt
    ARM 1: Kind: Experimental
    Label: cell transplantation
    Description: The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
    ARM 2: Kind: Experimental
    Label: Convention therapy
    Description: The control group just receive drug therapy.
  • Aspirin Drug
    Intervention Desc: aspirin 100mg,qd,po(patients with no fibrillation atrial)
    ARM 1: Kind: Experimental
    Label: cell transplantation
    Description: The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
    ARM 2: Kind: Experimental
    Label: Convention therapy
    Description: The control group just receive drug therapy.
  • Autologous hematopoiesis stem cell transplantation Procedure
    Intervention Desc: Every participant will be transplanted with about 4 million autologous peripheral blood stem cell(CD34+) through cerebral artery.
    ARM 1: Kind: Experimental
    Label: cell transplantation
    Description: The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from Baseline in NIH-stroke scale (NIHSS) at 12 months 1,3,6,12 months after cell transplantation Yes
Secondary Barthel index 1,3,6,12 months after cell transplantation Yes
Secondary perfusion magnetic resonance imaging scan 1,3,6,12 months after cell transplantation Yes
Secondary Modified Rankin Scale(mRS) 3,6,12 months after cell transplantation Yes

Sponsors