CompletedPhase 1/2

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

China20 participantsStarted 2011-11

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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

What they're measuring

Number of adverse events after infusion of BMSCs or EPCs.

Timeframe: 1 year

Trial details

NCT IDNCT01468064

SponsorSouthern Medical University, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12

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