Cell Therapy in Chronic Limb Ischemia

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 31, 2004

Primary Completion Date

February 28, 2009

Study Completion Date

February 28, 2009

Conditions
Peripheral Vascular Diseases
Interventions
PROCEDURE

BM-MNC preparation

"For autologous bone marrow - mononuclear cells preparation, 500ml of bone marrow are collected under general anaesthesia; mononuclear cells are separated using a blood-cells separator (COBE SPECTRA, GAMBRO BCT) and concentrated to produce a final volume of 40ml.~Cells are implanted 1 to 3 hours after preparation by multiple intramuscular injections into the gastrocnemius of the ischemic leg.(30 injection sites, 1 to 1.5 cm deep, spaced 1 cm apart,1 ml per injection)."

PROCEDURE

PB-MNC preparation

"Peripheral blood - mononuclear cells are collected through cytapheresis with the same blood-cells separator which is adjusted to obtain a 40 mL cell product. No previous mobilization with hematopoïetic growth-factor is administered.~Cells are implanted 1 to 3 hours after preparation by multiple intramuscular injections into the gastrocnemius of the ischemic leg.(30 injection sites, 1 to 1.5 cm deep, spaced 1 cm apart,1 ml per injection)."

Trial Locations (1)

44000

Patricia LEMARCHAND, Nantes

All Listed Sponsors
lead

CHU de Reims

OTHER

NCT00533104 - Cell Therapy in Chronic Limb Ischemia | Biotech Hunter | Biotech Hunter