Skip to main content
OpenTrials
Completed

NCT Number: NCT02605707

Autologous Endothelial Progenitor Cells Transplantation for Chronic Ischemic Stroke

Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.Stem cell transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy and safy of the transplantation of autologous endothelial progenitor cells in patients with chronic stroke.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, 510282, China

About this study

Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.It will brought heavy burden to patients themselves,their family and society.Drugs,rehabilitation excise and hyperbaric oxygen will improve functions after acute stroke.However,in the chronic ischemic stroke,there was few methods to improve the functions.In recently research,stem cell will be a new methods to improve the neural function after through differentiate to nervous cells and secrete some neurotrophic factors to repair the damage. In this study, the investigators will assess the safety and feasibility of intracerebral transplantation of autologous endothelial progenitor cells in patients with chronic ischemic stroke. The neurological outcome will be determined after transplantation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-80 chronic ischemia stroke or patients
  • With stroke history of more than 6 months, less than 60 months
  • NIHSS (NIH stroke scale) score of 7 or more points
  • Internal carotid artery territory infarction measured by MRI
  • Can be hospitalized and signed informed consent
  • With fewer effect by traditional post-stroke treatments or rehabilitations

Exclusion criteria

  • Lacunar infarction
  • Recurrent thrombotic diseases less than 6 months
  • Hemorrhage stroke,brain tumor or MRI show the occlusion is not in the middle cerebral artery territory
  • Pregnant women
  • Can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, AIDS, combine other tumor or special condition
  • Penicillin anaphylaxis or some other drugs allergy
  • Autoimmune disease
  • Inaccessibility for follow up

Treatment and study plan

Intravenous stem cell transplantation

Drug

Intravenous injection of autologous endothelial progenitor cells transplantation

Primary outcomes

  1. Change from baseline in Fugl-Meyer Scale at 24 months

    Time frame: 1,3,6,12 and 24months

Secondary outcomes

  1. Change from baseline in NIH Stroke Scale at 24 months

    Time frame: 1,3,6,12 and 24months

  2. Change from baseline in Barthel Index at 24 months

    Time frame: 1,3,6,12 and 24months

  3. Change from baseline in SSS at 24 months

    Time frame: 1,3,6,12 and 24months

  4. Change from baseline in mRS at 24 months

    Time frame: 1,3,6,12 and 24months

  5. Improvement of vision measured by brain visual examination

    Time frame: 1,3,6,12 and 24months

Sponsors and collaborators

Lead sponsor

Southern Medical University, China

Other

Collaborators

  • Second Affiliated Hospital of Guangzhou Medical University

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2020
First posted
Nov 16, 2015
Registry last updated
Apr 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.