Cell Therapy With Bone Marrow Mononuclear Cells in Critic... | NCT00377897

Studies
Cell Therapy With Bone Marrow Mononuclear Cells in Critical Leg Ischemia (CLI)

NCT00377897

Sponsor

University of Paris 5 - Rene Descartes

Status

Unknown status

Last Update Posted

Feb 16, 2009Estimated

Enrollment

20Estimated

Phase

Phase 1

Conditions

Critical Leg Ischemia

Interventions

cell therapy

Countries

France

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

Feb 2009

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 2005

Primary Completion Date

Sep 2008Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Sep 18, 2006

First Submission Date that Met QC Criteria

Sep 18, 2006

First Posted Date

Sep 19, 2006Estimated

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

Feb 13, 2009

Last Update Posted Date

Feb 16, 2009Estimated

Name	Class
Assistance Publique - Hôpitaux de Paris	OTHER

Description Module

Brief Summary

This study will treat by cell therapy 20 patients with critical leg ischemia (CLI) not eligible for revascularization or angioplasty. It will use exactly the same protocol as published by Tateishi-Yuyama et al. (Lancet 2002), using bone-marrow mononuclear cells (BMMNC).

Detailed Description

Patients will be included with CLI according to the TASC criteria. Under general anesthesia, 500 ml of bone marrow is harvested in both iliac crests. After isolation and concentration of the BMMNC in 30 ml, 40 injections of around 0.75 ml will be done in the gastrocnemius of the ischemic leg, within 3 hours after preparation of the cell therapy product.

Patients will then be followed-up every week during one month and then every month during one year.

This study was approved by the ethical committee of Paris-Broussais HEGP (France) and our french regulatory agency (AFSSAPS).

It began including patients in January 2005 and will last until December 2007.

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

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cell therapy	Procedure	Injection of Bone-Marrow mononuclear cells in the muscles of the calf.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ankle brachial index		6 months
Healing		1 year
Amputation rate		1 year

Secondary Outcomes

Measure	Description	Time Frame
TcPO2		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18
Signature of informed consent
Critical leg ischemia with ankle pressure < 70 mmHg
Ischemic ulcer or gangrene
No possibility of surgical revascularization
No possibility of angioplasty

Exclusion Criteria:

Cancer
Suspicion of a cancer on X-Ray, mammography or elevated PSA
Age < 18
Life expectancy < 6 months
Active retinopathy
Angioplasty or surgical revascularization within 3 months
Stoke within 3 months
HIV + or HCV/HBC+

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joseph Emmerich, MD, PhD	Contact	33 1 56 09 30 51		joseph.emmerich@egp.aphp.fr
Saliha Djane, MD	Contact	33 1 44 84 17 45		saliha.djane@sls.aphp.fr

Overall Officials

Name	Affiliation	Role
Joseph Emmerich	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emmerich	Recruiting	Paris	Paris	75015	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42265522	Derived	Oubari H, Labreuche J, Reytier C, Dignat-George F, Duong-Van-Huyen JP, Emmerich J, Gaussem P, Bruneval P, Blot-Chabaud M, Lellouch AG, Bardin N, Smadja DM. Soluble CD146 reflects altered endothelial and metabolic homeostasis in peripheral artery disease. Angiogenesis. 2026 Jun 9;29(3):41. doi: 10.1007/s10456-026-10064-6.
24105925

ID	Term
D001691	Biological Therapy
D013812	Therapeutics