CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 160 enrolled
Drug / intervention
Bone marrow punction +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00371371
NCT00371371Phase 2Completed
CompareCT.gov

Intra-arterial Infusion of Autologous Bone Marrow Mononuclear Cells in Patients With Chronic Critical Limb Ischemia: a Randomized, Placebo-controlled Clinical Trial

UMC Utrecht·interventional·Posted Sep 4, 2006·Updated Dec 13, 2012

In Brief

A Phase 2 clinical trial evaluating Bone marrow punction, BM-MNC infusion, and 1 other intervention for Peripheral Vascular Diseases and 4 related conditions. Completed, enrolled 160 participants across 1 site.

Detailed Summary

The purposes of this study are to determine whether intra-arterial injection of autologous stem cells is effective in the treatment of chronic limb ischemia (CLI), to characterize stem cell dysfunction in patients with CLI, and to relate the stem cell function with clinical outcome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Vascular Diseases, Arterial Occlusive Diseases, Leg Ulcer, Gangrene, Ischemia
CountriesNetherlands
CollaboratorsCatharijne Foundation

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 4, 2006
Enrollment StartSep 1, 2006
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 19.8 years ago

Interventions

Bone marrow punctionprocedure

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.

BM-MNC infusionprocedure

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

Placebo infusionprocedure

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.