Treatment of Chronic Critical Limb Ischemia With G-CSF-mo... | NCT01833585

Studies
Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells

NCT01833585

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Aug 17, 2018Actual

Enrollment

8Actual

Phase

Phase 3

Conditions

Critical Limb Ischemia
Atherosclerosis
Ischemic Ulcer
Gangrene

Interventions

Peripheral blood mononuclear cell

Countries

Thailand

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

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Apr 9, 2013

First Submission Date that Met QC Criteria

Apr 14, 2013

First Posted Date

Apr 17, 2013Estimated

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

Aug 15, 2018

Last Update Posted Date

Aug 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to determine the safety and efficacy of G-CSF-mobilized autologous peripheral blood mononuclear cell injection to ischemic limbs of patients with critical limb ischemia.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
peripheral blood mononuclear cells	Experimental	peripheral blood mononuclear cells will be injected to calf muscle of critical limb ischemia	Biological: Peripheral blood mononuclear cell

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peripheral blood mononuclear cell	Biological	Peripheral blood mononuclear cell solution 59 cc will be injected to the gastrocnemius muscle of ischemic limb of patients with critical limb ischemia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients without major amputation after mononuclear cell injection		3 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with critical limb ischemia confirmed by toe pressure, ABI, TCOM
Levels of arterial occlusion are femoropopliteal or tibioperoneal occlusion
Poor distal artery runoff
Age 18-70 year

Exclusion Criteria:

Planned for major amputation within 4 weeks
Receive blood component within 4 weeks
Acute myocardial infarction
severe valvular heart disease
renal failure
liver failure
Cancer
Hypercoagulable state
Severe infection
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nuttawut Sermsathanasawadi, MD.,Ph.D.	Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vascular Surgery, Siriraj Hospital, Mahidol University		Bangkoknoi	Bangkok	10700	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D000089802	Chronic Limb-Threatening Ischemia
D050197	Atherosclerosis
D005734	Gangrene

Ancestor Terms

ID	Term
D058729	Peripheral Arterial Disease
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided