Study of the Clinical Efficacy of Autologous SCT in Patie... | NCT01311011

Studies
Study of the Clinical Efficacy of Autologous SCT in Patients With Critical Limb Ischemia

NCT01311011

Sponsor

King Faisal Specialist Hospital & Research Center

Status

Unknown status

Last Update Posted

Dec 13, 2011Estimated

Enrollment

26Estimated

Phase

Not provided

Conditions

Critical Limb Ischemia

Interventions

Countries

Saudi Arabia

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

ID	Type	Description	Link
RAC# 2081-026

Status Module

Record Verification Date

Dec 2011

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 2008

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 6, 2011

First Submission Date that Met QC Criteria

Mar 8, 2011

First Posted Date

Mar 9, 2011Estimated

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 11, 2011

Last Update Posted Date

Dec 13, 2011Estimated

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

Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in patients with Critical Limb Ischemia

Detailed Description

Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in patients with Critical Limb Ischemia

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

26Estimated

Name	Type	Description	Arm Group Labels	Other Names
SCT	Procedure	SCT

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with Critical Limb Ischemia

Exclusion Criteria:

Patients with other than Critical Limb Ischemia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with Critical Limb Ischemia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
H Al-Zahrani, M.D.	Contact	+966-1-4423949

Overall Officials

Name	Affiliation	Role
H Al-Zahrani, M.D.	KFSH & RC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kfsh & Rc	Recruiting	Riyadh			Saudi Arabia

Condition Browse Module

MeSH Terms

ID	Term
D000089802	Chronic Limb-Threatening Ischemia

Ancestor Terms

ID	Term
D058729	Peripheral Arterial Disease
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases

Browse Leaves

Not provided

Browse Branches

Not provided