Boosting the bone biology. The effect of oral L-citrulline supplementation on mesenchymal stem cell concentration and osteogenic potential of BMAC in healthy humans. A randomized open-label pilot study.

• Conditions: Botaandoeningen. fracturen; Bone metabolism; osteogenic differentiation

• Registration Number: NL-OMON56806
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- Age >18 years
- Patients are planned for the removal of OSM under general anaesthesia or
spinal anaesthesia where the iliac crest is anesthetized.

Exclusion Criteria

- Age <18 years
- Patients with a reported allergy for L-citrulline.
- Chronic use of NSAIDs or use of NSAIDs 14 days prior to surgery
- Chronic use of immunosuppressant medications or use 14 days prior to surgery
- The use of bisphosphonates
- Inability to stop therapeutic anticoagulants prior to surgery
- Surgery under general anaesthesia or spinal block not possible
- Unmanaged comorbidities known to effect bone metabolism: Such as diabetes,
osteoporosis, recent polytrauma
- Subject has (had) an active infection or fever in the weeks prior to the
surgery
- Malnutritional state based on The Simplified Nutritional Appetite
Questionnaire (SNAQ).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The osteogenic potential of MSCs in the BMAC samples.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Cell viability and the amount of MSCs<br /><br>Adverse events </p><br>