Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Peripheral Vascular DiseasesArterial Occlusive DiseasesLeg UlcerGangreneIschemia
Interventions
PROCEDURE

Bone marrow punction

A total volume of 100 ml bone marrow will be aspirated from the iliac crest under local anaesthesia (lidocaine) according to local routine. To maximise the patients comfort, 5-10 mg midazolam and 50 ug fentanyl will be administered intravenously.

PROCEDURE

BM-MNC infusion

Repeated intra-arterial infusion of autologous BM-MNC into the common femoral artery

PROCEDURE

Placebo infusion

Repeated intra-arterial infusion of placebo (PBS/4% HAS/heparin, coloured with autologous erythrocytes to match the colour of BM-MNC suspension) into the common femoral artery.

Trial Locations (1)

3508 GA

University Medical Center Utrecht (UMC Utrecht), Utrecht

All Listed Sponsors
collaborator

Catharijne Foundation

UNKNOWN

lead

UMC Utrecht

OTHER

NCT00371371 - Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI) | Biotech Hunter | Biotech Hunter