Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia

Last updated: July 5, 2011
Sponsor: Leiden University Medical Center
Overall Status: Trial Status Unknown

Phase

2/3

Condition

Vascular Diseases

Circulation Disorders

Claudication

Treatment

N/A

Clinical Study ID

NCT00539266
P07.058
  • Ages > 16
  • All Genders

Study Summary

The investigators propose confirm and extend the findings of open studies on the apparent efficacy of bone-marrow derived mononuclear cells for the induction of arteriogenesis in patients with severe claudication or critical leg ischemia and pay special attention to the influence of diabetic disease on the outcome of the study and to the possible pro-atherogenic/ pro-inflammatory effects of BM-MNC injections.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • persistent (>3 months) disabling claudication (Fontaine's stages IIb or Rutherford'scategories 3, viz. pain free walking distance less than 100 meter) despite optimaltherapy or critical limb ischemia (Fontaine's stages III/IV or Rutherford's categories 4-6)

  • ineligibility for angioplasty or bypass procedures

  • male of female, >18 years old

  • life expectancy > 1 year

  • written informed consent

Exclusion

Exclusion Criteria:

  • candidates for angioplasty or bypass procedures

  • inability to undergo bone marrow harvesting

  • any condition in the affected limb that is anticipated to require surgicalintervention in the first weeks after BM-MNC treatment

  • life threatening co-morbidity

  • poorly controlled diabetes (HbA1C > 10%)

  • active malignancy in the 5 years prior to treatment

  • INR >1.5 at the time of bone-marrow harvest

  • bleeding diathesis

  • inability to undergo arterial catheterization

  • inability to follow the protocol and to comply with the follow up requirements

  • any other conditions that, in the opinion of the investigators, could interfere withthe therapy or could pose a significant threat to the subject if the investigationaltherapy was to be initiated

Study Design

Total Participants: 108
Study Start date:
October 01, 2007
Estimated Completion Date:
October 31, 2012

Study Description

Although the safety and beneficial effects of intramuscular transplantation of bone marrow derived mononuclear cells procedure appear well documented, a number of critical question regarding application of BM-MNC for peripheral vascular disease remain to be answered. First, although the original study has been partially performed as semi-blinded study (patients with double sided claudication were recruited and blindly treated with BM-MNC in one leg and peripheral blood injections in the other leg), this approach does exclude a placebo effect. Second, although patients with mild diabetes were included in the protocol, the results for diabetic patients were not analyzed separately. Diabetic disease is characterized by monocyte and endothelial progenitor cell dysfunction and it is still unclear whether this approach is also effective in diabetic patients. Third, although six-month results are reported long-term efficacy has not been established yet.

To address these issues, the investigators now propose confirm and extend the findings from open studies in a randomized double-blind study in patients with severe claudication or critical leg ischemia and pay special attention to the influence of diabetic disease on the outcome of the study and to the possible pro-atherogenic/ pro-inflammatory effects of BM-MNC injections.

Connect with a study center

  • Leiden University Medical Center

    Leiden, 2300RC
    Netherlands

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.