Obtaining healthy bone marrow and blood to put JUVENTAS in perspective

Withdrawn

Conditions: 10003216
Critical Limb Ischemia (CLI) / Peripheral Arterial Occlusive Disease (PAOD)

Registration Number: NL-OMON35539

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 52

Inclusion Criteria

- Age >18 years;
- Patients undergoing surgical procedures during which bony structures containing active bone marrow are encountered (eg pelvic girdle, caput femoris, acetabulum, distal femur or proximal tibia);
- Scheduled for surgical intervention;
- Approval of both the anaesthetist and the surgeon performing the surgical procedure;
- Written informed consent.

Exclusion Criteria

- History of overt cardiovascular disease;
- Major trauma involving multiple bones or damaged internal organs;
- Known disease originating from the bone marrow (ie leukaemia, lymphoma, metastatic disease);
- Chronic autoimmune disease (ie SLE, rheumatic arthritis etc);
- Known infection with HIV, hepatitis B or C virus.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters tested in this study are the progenitor cell levels,<br /><br>of EPC in particular, in BM and blood of healthy controls and how they relate<br /><br>to levels in patients with CLI. Cells will be counted and characterized using<br /><br>fluorescence activated cell sorting (FACS). This will be performed using the<br /><br>same protocols as for patients suffering from CLI, which participate in the<br /><br>Juventas trial.<br /><br>With this method the amount of EPCs can be assessed as well as certain other<br /><br>cell populations potentially involved in vascular health and<br /><br>neovascularization. Antibodies to CD34, CD31, KDR, CD133, CD45, CD184, CD140b,<br /><br>CD14 and CD26 will be used.</p><br>

Secondary Outcome Measures