Stem Cell Therapy for Patients With Vascular Occlusive Di... | NCT02304588

Studies
Stem Cell Therapy for Patients With Vascular Occlusive Diseases Such as Diabetic Foot

NCT02304588

Sponsor

Chinese PLA General Hospital

Status

Unknown status

Last Update Posted

Dec 2, 2014Estimated

Enrollment

20Estimated

Phase

Phase 1

Conditions

Diabetic Foot
Lower Limb Ischemia

Interventions

Mesenchymal stem cells

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

Nov 2014

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

Jan 2013

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Nov 12, 2014

First Submission Date that Met QC Criteria

Dec 1, 2014

First Posted Date

Dec 2, 2014Estimated

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

Dec 1, 2014

Last Update Posted Date

Dec 2, 2014Estimated

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

Mesenchymal stem cells with multidirectional differentiation potential,autologous stem cell transplantation into ischemic foot, make its differentiation to form new blood capillary, improve and restore the local blood flow.

Detailed Description

Not provided

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mesenchymal stem cells	Experimental	Maximal amount of MSC cells injected: 10-20*10^6 cells (up to volume of 20mL, depending on the wound size & patient weight).	Biological: Mesenchymal stem cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mesenchymal stem cells	Biological	10-20 x 10^6 cells/20mL	Mesenchymal stem cells

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of Adverse Events	Frequency and severity of Adverse Events	6 months

Secondary Outcomes

Measure	Description	Time Frame
Relative Wound Area Regression of 40% or More at 6 Week		6 week

Other Outcomes

Measure	Description	Time Frame
Reduced pain	Reduced pain, measured by VAS scale and use of analgesics	6 months after treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

the age of 30-78 years old, men and women there is no limit.
in accordance with the ministry of health in higher medical colleges and universities teaching material the sixth edition of the annals of diabetic foot diagnostic criteria.
with severe lower limb ischemia (defined as the resting state of ankle brachial index (ABI) 0.4-0.85, accompanied by resting or intermittent toe line.
treatment on a voluntary basis, and sign the informed consent.

Exclusion Criteria:

with severe heart, liver, kidney, lung function failure or general condition is very poor can't tolerate the stem cell transplant.
clear over the past five years tumor markers in patients with malignant disease and blood levels increased significantly.
the prodrome of acute infectious diseases.
participated in clinical subjects within three months before test.
adherence is poor, can not complete the course.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

78 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
xiaobing FU	Contact	+86(10)937516

Overall Officials

Name	Affiliation	Role
xiaobing FU	Chinese PLA General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chinese PLA General Hospital	Recruiting	Beijing	Beijing Municipality	100039	China

Condition Browse Module

MeSH Terms

ID	Term
D017719	Diabetic Foot

Ancestor Terms

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided