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

NCT00371371 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2012-12-13

No results posted yet for this study

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.

Conditions

  • Peripheral Vascular Diseases
  • Arterial Occlusive Diseases
  • Leg Ulcer
  • Gangrene
  • Ischemia

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.

Sponsors & Collaborators

  • Catharijne Foundation

    collaborator UNKNOWN

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Frans L Moll, MD, PhD · UMC Utrecht

  • Marianne C Verhaar, MD, PhD · UMC Utrecht

  • Ralf W Sprengers, MD, PhD · UMC Utrecht

  • Martin Teraa, MD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00371371 on ClinicalTrials.gov