Allogeneic mesenchymal Stromal cells for Angiogenesis and neovascularization in no-option Ischemic Limbs

Phase 2

Withdrawn

Conditions: PAOD Fontaine 3-4
Severe Limb Ischemia (SLI)
10003216

Registration Number: NL-OMON45407

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 60

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) <0.6 or non-compressible/ unreliable
-not eligible for surgical or endovascular revascularization
-written informed consent.

Exclusion Criteria

-history of neoplasm or malignancy in the past 10 years
-serious known concomitant disease with life expectancy <1 year
-Rutherford 6 in which amputation on the short term (within 1-2 weeks)
is inevitable
-Pregnancy or unwillingness to use birth control measures such as oral
contraceptives or other (hormonal, uterine implant, barrier method)
precautions during study
-uncontrolled infection with systemic symptoms
-follow-up impossible

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is therapy success at 6 months, which is a composite outcome<br /><br>measure considering mortality, limb status, clinical status (Rutherford<br /><br>classification) and changes in pain score. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are the incidence of major (amputation through or above the<br /><br>ankle joint) and minor (distal from the ankle joint) amputations, mortality,<br /><br>changes in the number and extent of leg ulcers, ulcer healing, clinical<br /><br>classification, pain-free walking distance (PFWD), ankle-brachial (ABI) and<br /><br>toe-brachial index (TBI), and quality of life (EuroQoL 5-D (EQ5D) and SF-36).<br /><br>In addition to biochemical parameters we will assess markers for endothelial<br /><br>activation and injury, inflammation, oxidative stress, circulating progenitor<br /><br>cells, cytokines and growth factors and immunological responses.</p><br>