A Prospective, Open, Non-randomized Phase I/II Study of T... | NCT00765050

Studies
A Prospective, Open, Non-randomized Phase I/II Study of Therapeutic Angiogenesis in Diabetic Patients With Critic Ischemia of Lower Limbs While Administering Positive CD133 Mobilized With G-CSF

NCT00765050

Sponsor

PETHEMA Foundation

Status

Terminated

Last Update Posted

Apr 7, 2014Estimated

Enrollment

13Actual

Phase

Phase 1Phase 2

Conditions

Diabetic Patients With Critic Ischemia in Lower Limbs Who Are Administered With CD133+ Cells Mobilized by G-CSF

Interventions

CD133+ cells transplant

Countries

Spain

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

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Oct 1, 2008

First Submission Date that Met QC Criteria

Oct 1, 2008

First Posted Date

Oct 2, 2008Estimated

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

Apr 4, 2014

Last Update Posted Date

Apr 7, 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

The primary objective is to analyze the safety and efficacy of CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.

The secondary objectives are:

To determine the safety of the intramuscular administration of CD133+ cells that have been mobilized from peripheral blood.
To determine the CD133+ capacity to increase the re-vascularization at lower limbs in diabetic patients with critic ischemia in the lower limbs.
To evaluate the patient global health condition using the notified results of the SF-36 questionnaires completed by patients

Detailed Description

A total of up to 20 diabetic patients with critic ischemia of lower limbs will be included in the study. Patients will be administered with CD133+ cells, that previously have been obtained of their peripheral blood after mobilization with G-CSF

The study is divided in three phases:

Pre-treatment (previous 4 weeks of CD133+ cells mobilization). Treatment (cells mobilization, CD133+ transplant, 24 hours after infusion visit, 4, 12 and 24 weeks after transplant visits) Follow-up (9 and 12 months after transplant visits)

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CD133+ cells	Experimental	CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.	Biological: CD133+ cells transplant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CD133+ cells transplant	Biological	intramuscular administration of CD133+ cells that have been mobilized from peripheral blood.	CD133+ cells

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
analyze the safety and efficacy of CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.		12 months

Secondary Outcomes

Measure	Description	Time Frame
To determine the safety of the intramuscular administration of CD133+ cells that have been mobilized from peripheral blood		2 months
To determine the CD133+ capacity to increase the re-vascularization at lower limbs in diabetic patients with critic ischemia in the lower limbs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

According to the investigator opinion, patient is able to carry out with all the clinical trial requirements
Patient must volunteer sign the inform consent before any study specific test, that is not part of the common patient attention, is performed. Patient must know that he/she can abandon the study at any time with no damage to his/her posterior attention
Age 18 to 75
A diagnosis of chronic critic ischemia of the lower limbs
Diabetes Mellitus active
III or IV stages (Fontaine classification): resting pain, ulcer or minor gangrene with no major amputation
General contraindication or local inoperability or refractory/progression after previous surgical treatment, according to the investigator criteria
If female reproductive potential, negative pregnancy test

Exclusion Criteria:

Pregnant or currently breast feeding women
Acute myocardial infarction within the last 3 years
Non re-vascular unstable angina pectoris
History of ischemia stroke within the last 3 years
Neoplasia at the time of inclusion or Chemotherapy or Radiotherapy treatment in the last 5 years
Chronic renal insufficiency
G-CSF contraindication
A non well controlled serious concomitant disease
History of serious thrombotic episodes within the past 3 years
Patients who have received other investigational therapy within 30 days previous to the study inclusion
Patients currently in other clinical trial or receiving any other investigational agent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Mª Consuelo Del Cañizo, Dr	Hospital Clínico de Salamanca	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Virgen de la Arrixaca		Murcia			Spain
Clínica Universitaria de Navarra

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
1834364	Background	Second European Consensus Document on chronic critical leg ischemia. Circulation. 1991 Nov;84(4 Suppl):IV1-26. No abstract available.
17330127	Background	Mohler ER 3rd. Therapy insight: peripheral arterial disease and diabetes--from pathogenesis to treatment guidelines. Nat Clin Pract Cardiovasc Med. 2007 Mar;4(3):151-62. doi: 10.1038/ncpcardio0823.