Trial | NCT01468064  Report issue

Title

Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Ischemic Stroke
Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Patients With Ischemic Stroke: a Randomized Controlled Trial

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
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.
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.
Study Started
Nov 30
2011
Primary Completion
Dec 31
2015
Study Completion
Mar 31
2017
Last Update
Apr 02
2021

Genetic Autologous BMSCs transplantation

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.

  • Other names: Autologous Bone marrow stromal cells transplantation, Autologous Mesenchymal stem cells transplantation

Genetic Autologous EPCs transplantation

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.

  • Other names: Autologous endothelial progenitor cells transplantation

Genetic IV infusion of placebo

IV infusion of saline plus 5% autologous serum.

  • Other names: Placebo control group

BMSCs group Experimental

EPCs group Experimental

Control group Placebo Comparator

Criteria 

Inclusion Criteria:

Patients aged 18 to 80 years, within 7 days of the onset of symptoms
Ischemic lesion within the MCA territory as assessed using diffusion-weighted imaging (DWI)
The National Institutes of Health Stroke Scale (NIHSS) ≥ 7 at day 7 after the onset
Signed informed consent

Exclusion Criteria:

Lacunar syndrome
Diagnosis other than ischemic stroke(eg. Intracranial hemorrhage or Intracranial tumor)
Hematological causes of stroke
Severe respiratory, hepatic, or renal disorders
Presence of severe febrile illness or viral diseases
Malignant diseases
Presence of autoimmune diseases
Positive response of penicillin skin test, or multiple drug allergies
Breast-feeding or pregnant women
No Results Posted