Autologous Endothelial Progenitor Cells Transplantation for Chronic Ischemic Stroke

NCT02605707 | Completed Phase 1

• 1 other identifier: 2011Y1-00033-6
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Endothelial Progenitor Cells; Transplantation; Stroke

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Fugl-Meyer Scale at 24 months

  1,3,6,12 and 24months

Secondary Outcomes (5)

• Change from baseline in NIH Stroke Scale at 24 months

  1,3,6,12 and 24months

• Change from baseline in Barthel Index at 24 months

  1,3,6,12 and 24months

• Change from baseline in SSS at 24 months

  1,3,6,12 and 24months

• Change from baseline in mRS at 24 months

  1,3,6,12 and 24months

• Improvement of vision measured by brain visual examination

  1,3,6,12 and 24months

Study Arms (2)

Intravenous stem cell transplantation

EXPERIMENTAL

Intravenous transplantation of autologous endothelial progenitor cells plus conventional treatment include rehabilitation

Drug: Intravenous stem cell transplantation

Conventional treatment

NO INTERVENTION

Control group receive conventional stroke treatment that include rehabilitation

Interventions

Intravenous stem cell transplantation DRUG

Intravenous injection of autologous endothelial progenitor cells transplantation

Intravenous stem cell transplantation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southern Medical University, China: lead
• Second Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (1)

Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, 510282, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• ZhenZhou Chen, MD, phD

  Department of Neurosurgery, Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Neurosurgery, Zhujiang Hospital

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: November 16, 2015
• Study Start: November 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2020
• Last Updated: April 2, 2021

Record last verified: 2021-04

Locations

CN (1)