Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI)
CompletedPhase 1, Phase 2NCT00371371
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
- Official title
- Intra-arterial Infusion of Autologous Bone Marrow Mononuclear Cells in Patients With Chronic Critical Limb Ischemia: a Randomized, Placebo-controlled Clinical Trial
- Conditions
- Peripheral Vascular Diseases
- Arterial Occlusive Diseases
- Leg Ulcer
- Gangrene
- Ischemia
- Interventions
- Procedure: Bone marrow punction
- Procedure: BM-MNC infusion
- Procedure: Placebo infusion
- Sponsor
- UMC Utrecht
- Collaborators
- Catharijne Foundation
- Start date
- 2006-09
- Primary completion
- 2012-12
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Netherlands
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00371371