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

Critical Leg Ischemia Clinical Trial

Official title:

Optimisation d'un Produit de thérapie Cellulaire Autologue Par Cellules mononucléées médullaires Dans l'ischémie Critique Des Membres inférieurs liée à l'athérosclérose

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00377897
• Other study ID #: OPTIPEC
• Status: Recruiting
• Phase: Phase 1
• First received: September 18, 2006
• Last updated: February 13, 2009
• Start date: January 2005
• Est. completion date: December 2009

Study information

• Verified date: February 2009
• Source: University of Paris 5 - Rene Descartes
• Contact: Joseph Emmerich, MD, PhD
• Phone: 33 1 56 09 30 51
• Email: joseph.emmerich[@]egp.aphp.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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+

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Leg Ischemia
• Ischemia

Intervention

Procedure:
• cell therapy
Injection of Bone-Marrow mononuclear cells in the muscles of the calf.

Locations

Country	Name	City	State
France	Emmerich	Paris

Sponsors (2)

Lead Sponsor	Collaborator
University of Paris 5 - Rene Descartes	Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ankle brachial index		6 months	No
Primary	Healing		1 year	No
Primary	Amputation rate		1 year	No
Secondary	TcPO2		6 months	No