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Autologous Endothelial Progenitor Cells Transplantation for Chronic Ischemic Stroke

Primary Purpose

Stroke

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Intravenous stem cell transplantation

About this trial

This is an interventional treatment trial for Stroke focused on measuring Endothelial Progenitor Cells, Transplantation, Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zhujiang Hospital, Southern Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intravenous stem cell transplantation

Conventional treatment

Arm Description

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

Control group receive conventional stroke treatment that include rehabilitation

Outcomes

Primary Outcome Measures

Change from baseline in Fugl-Meyer Scale at 24 months

Secondary Outcome Measures

Change from baseline in NIH Stroke Scale at 24 months

Change from baseline in Barthel Index at 24 months

Change from baseline in SSS at 24 months

Change from baseline in mRS at 24 months

Improvement of vision measured by brain visual examination

Full Information

NCT ID

NCT02605707

First Posted

November 12, 2015

Last Updated

April 1, 2021

Sponsor

Southern Medical University, China

Collaborators

Second Affiliated Hospital of Guangzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02605707

Brief Title

Autologous Endothelial Progenitor Cells Transplantation for Chronic Ischemic Stroke

Official Title

Autologous Endothelial Progenitor Cells Transplantation for Chronic Ischemic Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Southern Medical University, China

Collaborators

Second Affiliated Hospital of Guangzhou Medical University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Endothelial Progenitor Cells, Transplantation, Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intravenous stem cell transplantation

Arm Type

Experimental

Arm Description

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

Arm Title

Conventional treatment

Arm Type

No Intervention

Arm Description

Control group receive conventional stroke treatment that include rehabilitation

Intervention Type

Drug

Intervention Name(s)

Intravenous stem cell transplantation

Intervention Description

Intravenous injection of autologous endothelial progenitor cells transplantation

Primary Outcome Measure Information:

Title

Change from baseline in Fugl-Meyer Scale at 24 months

Time Frame

1,3,6,12 and 24months

Secondary Outcome Measure Information:

Title

Change from baseline in NIH Stroke Scale at 24 months

Time Frame

1,3,6,12 and 24months

Title

Change from baseline in Barthel Index at 24 months

Time Frame

1,3,6,12 and 24months

Title

Change from baseline in SSS at 24 months

Time Frame

1,3,6,12 and 24months

Title

Change from baseline in mRS at 24 months

Time Frame

1,3,6,12 and 24months

Title

Improvement of vision measured by brain visual examination

Time Frame

1,3,6,12 and 24months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ZhenZhou Chen, MD, phD

Organizational Affiliation

Department of Neurosurgery, Zhujiang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhujiang Hospital, Southern Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510282

Country

China

12. IPD Sharing Statement

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Autologous Endothelial Progenitor Cells Transplantation for Chronic Ischemic Stroke

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