Autologous Bone Marrow Mesenchymal Stem Cell Transplantat... | NCT02564328

Studies
Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke

NCT02564328

Sponsor

Southern Medical University, China

Status

Unknown status

Last Update Posted

Sep 30, 2015Estimated

Enrollment

40Estimated

Phase

Phase 1

Conditions

Stroke

Interventions

Intravenous stem cell transplantation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Nov 2016Estimated

Completion Date

Nov 2017Estimated

First Submitted Date

Sep 29, 2015

First Submission Date that Met QC Criteria

Sep 29, 2015

First Posted Date

Sep 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2015

Last Update Posted Date

Sep 30, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaodan Jiang, Zhujiang Hospital,Southern Medical University, China, Southern Medical University, ChinaPrincipal Investigator

Lead Sponsor

Southern Medical University, ChinaOTHER

Collaborators

Name	Class
Second Affiliated Hospital of Guangzhou Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 bone marrow mesenchymal stem 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 bone marrow mesenchymal stem cells in patients with chronic ischemic stroke. The neurological outcome will be determined after transplantation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intravenous stem cell transplantation	Active Comparator	Intravenous transplantation of autologous bone marrow mesenchymal stem cell plus conventional treatment include rehabilitation	Genetic: Intravenous stem cell transplantation
Conventional treatment	No Intervention	Control group receive conventional stroke treatment that include rehabilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravenous stem cell transplantation	Genetic	Intravenous injection of autologous bone marrow mesenchymal stem cell transplantation	Intravenous stem cell transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in Fugl-Meyer Scale at 12 months		1,3,6 and 12 months

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in NIH Stroke Scale at 12 months		1,3,6 and 12 months
Change from baseline in Barthel Index at 12 months		1,3,6 and 12 months
Change from baseline in SSS at 12 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaodan Jiang, MD,PhD	Contact	86 20 61643268		jiangxiao_dan@163.com

Overall Officials

Name	Affiliation	Role
Xiaodan Jiang, MD,PhD	Southern Medical University, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xiaodan Jiang	Recruiting	Guangzhou	Guangdong	510282	China

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided