Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Ischemic Stroke "AMETIS"

Recruiting

Phase 1/2 Results N/A

Trial Description

The purpose of this study is to evaluate the feasibility, efficacy, and safety of autologous transplantation of ex vivo expanded bone marrow stromal cells (BMSCs)and endothelial progenitor cells (EPCs) for treatment of patients with ischemic stroke.

Detailed Description

This study is a multi-center, single-blind, randomized, parallel controlled trail. Patients with acute cerebral infarcts within the middle cerebral arterial territory and with severe neurological deficits will be enrolled and randomly allocated into 3 groups: autologous BMSCs transplantation group, autologous EPCs transplantation group and Placebo control group. Randomization codes were established by the study statistician and were revealed only to the stem cell laboratory technician responsible for separating the cells into aliquots or preparing the placebo material. All patients will undergo a Bone Marrow aspiration procedure at 7 days after symptom onset. BMSCs and EPCs will be expanded ex vivo and then intravenously infused into own body, respectively. The control group will not receive cell therapy. Observe will followed for up to 1 year after the onset. Neurological score, neuroimaging, mortality of any cause, side effects, and new-onset comorbidities will be monitored and compared between each groups.

Conditions

Interventions

  • Autologous BMSCs transplantation Genetic
    Other Names: Autologous Bone marrow stromal cells transplantation; Autologous Mesenchymal stem cells transplantation
    Intervention Desc: The first transplantation: 2.5 million cells per kg autologous BMSCs suspended in 100 ml saline plus 5% autologous serum are infused intravenously approximately 4 weeks after bone marrow aspiration. The second transplantation: the same amount of cells are again transplanted approximately 1 weeks after initial boosting.
    ARM 1: Kind: Experimental
    Label: BMSCs group
  • Autologous EPCs transplantation Genetic
    Other Names: Autologous endothelial progenitor cells transplantation
    Intervention Desc: The first transplantation: 2.5 million cells per kg autologous EPCs suspended in 100 ml saline plus 5% autologous serum are infused intravenously approximately 4 weeks after bone marrow aspiration. The second transplantation: the same amount of cells are again transplanted approximately 1 weeks after initial boosting.
    ARM 1: Kind: Experimental
    Label: EPCs group
  • IV infusion of placebo Genetic
    Other Names: Placebo control group
    Intervention Desc: IV infusion of saline plus 5% autologous serum.
    ARM 1: Kind: Experimental
    Label: Control group

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety evaluation and tolerability of a single treatment administration of autologous cultured bone marrow stromal cells and endothelial progenitor cells. 1 year Yes
Secondary Changes in functional outcomes measured by the modified Rankin Scale (mRS) and the Barthel index (BI). 1 year No
Primary Number of adverse events after infusion of BMSCs or EPCs. 1 year Yes

Sponsors