PAOD Fontaine 3-4 Severe Limb Ischemia (SLI)
Conditions
Interventions
Intramuscular allogeneic BM-MSC injection: MSCs will be extracted from BM of
healthy volunteers, expanded with human platelet lysate, and stored. Patients
will be randomized (1:1) to receive intramu
Angiogenesis
Clinical trial
Mesenchymal stromal cells
Severe limb ischemia
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: -age >18 years -severe peripheral artery disease (PAD) (Fontaine class III or IV) (Rutherford 4 or 5) -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 (ABI)
Exclusion criteria
Exclusion criteria: -history of neoplasm or malignancy in the past 10 years -serious known concomitant disease with life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is therapy success at 6 months, which is a composite outcome measure considering mortality, limb status, clinical status (Rutherford classification) and changes in pain score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are the incidence of major (amputation through or above the ankle joint) and minor (distal from the ankle joint) amputations, mortality, changes in the number and extent of leg ulcers, ulcer healing, clinical classification, pain-free walking distance (PFWD), ankle-brachial (ABI) and toe-brachial index (TBI), and quality of life (EuroQoL 5-D (EQ5D) and SF-36). In addition to biochemical parameters we will assess markers for endothelial activation and injury, inflammation, oxidative stress, circulating progenitor cells, cytokines and growth factors and immunological responses. | — |
Countries
The Netherlands
Outcome results
None listed