Status:
COMPLETED
Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI)
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Catharijne Foundation
Conditions:
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 dysfunctio...
Detailed Description
Despite advances in surgical and radiological vascular techniques, a significant number of patients with chronic critical limb ischaemia (CLI) are not eligible for revascularization procedures, often ...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Severe infra-popliteal peripheral arterial occlusive disease \[PAOD\] (Fontaine class IIb, III or IV)
- Invalidating intermittent claudication, persistent, recurring rest pain requiring analgesia and/or non-healing ulcers present for \> 4 weeks without evidence of improvement in response to conventional therapies
- Ankle brachial index \< 0.6 or "unreliable"
- Not eligible for surgical or radiological revascularization
- Written informed consent
Exclusion
- History of neoplasm or malignancy in the past 10 years
- Serious known concomitant disease with life expectancy of less than one year
- Anticipated inability to obtain 100 ml of bone marrow aspirate
- Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus
- Follow-up impossible
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00371371
Start Date
September 1 2006
End Date
December 1 2012
Last Update
December 13 2012
Active Locations (1)
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1
University Medical Center Utrecht (UMC Utrecht)
Utrecht, Netherlands, 3508 GA