Stem Cells for Treating Critical Ischemia | NCT00488020

Studies
Stem Cells for Treating Critical Ischemia

NCT00488020

Sponsor

Instituto de Molestias Cardiovasculares

Status

Unknown status

Last Update Posted

Jun 13, 2008Estimated

Enrollment

10Estimated

Phase

Phase 1

Conditions

Critical Limb Ischemia
Ischemic Ulcers

Interventions

stem cells transplant

Countries

Brazil

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2007

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

Apr 2006

Primary Completion Date

Not provided

Completion Date

Jun 2007Estimated

First Submitted Date

Jun 15, 2007

First Submission Date that Met QC Criteria

Jun 18, 2007

First Posted Date

Jun 19, 2007Estimated

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

Jun 12, 2008

Last Update Posted Date

Jun 13, 2008Estimated

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

Collection of bone marrow blood Selection of mononuclear cells dilution with albumin injection into the calf muscles through 40 shots

Detailed Description

About 500cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution in albumin (40cc)the mononuclear cells are injected into the calf muscles through 40 shots.This procedure is indicated for patients with lower limb ischemia on whom all the others known therapies have failed

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

10Estimated

Name	Type	Description	Arm Group Labels	Other Names
stem cells transplant	Procedure

Measure	Description	Time Frame
Suppress pain and heal ischemic ulcers		6 months

Measure	Description	Time Frame
improve quality of life		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fontaine's classification grade 3 and 4 patients

Exclusion Criteria:

Record of cancer in the last 5 years
Over 80 years
Diabetic retinopathy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 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
Jose D Araújo, MD	Contact	551732034000		imc.terapia.celular@terra.com.br

Overall Officials

Name	Affiliation	Role
Jose D Araújo, MD	Instituto de Molestias Cardiovasculares	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto de Molestias Cardiovasculares	Recruiting	São José do Rio Preto	São Paulo	15015-210	Brazil

Type	Date	Date Unknown
Release	Sep 29, 2010
Reset	Oct 21, 2010
Release	Aug 25, 2011
Reset	Sep 28, 2011
Release	Aug 2, 2013
Reset	Sep 17, 2013

Submission Tracking

Estimated Results First Submitted Date

Sep 29, 2010

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 29, 2010			Oct 21, 2010
Aug 25, 2011

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