Bone augmentation with autologous adipose tissue-derived mesenchymal stem cells and calcium phosphate carriers in the human maxillary sinus floor elevation model

• Conditions: jaw bone athrophy; jaw bone loss; 10005959

• Registration Number: NL-OMON35169
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- minimal bone height of 4 mm at planned implant site(s)
- no local need for horizontal bone augmentation
- healthy appearance sinus maxillaris
- smoking below 10 sigarettes a day
- Age 18 years or older

Exclusion Criteria

- History of malignancy or chronic infectious disease (i.e. HIV, Hepatitis)
- irradiation history in jaw area
- destructive sinus surgery indicated during anamnesis
- endocarditis or heart valve abnormalities, or heart valve prostheses
- abnormalities in the immune system, or use of immune suppressants
- severe bone metabolic disorders (e.g. severe osteoporosis treated with bisphosphonates)
- Chronic use (>7 consecutive days) of anticoagulants (such as aspirin) or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within 15 days prior to lipoaspriation
- Signs or symptoms of infection at the time of the surgical procedure
- pregnant or nursing, or intention to become pregnant

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Occurrence of any AE or SAE related to the product and/or procedure (in order<br /><br>to determine the follow-up regime for dose-response studies) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Radiological/clinical assessment of bone formation<br /><br>2) Histological/histomorphometrical evaluation of biopsies taken 6 months after<br /><br>sinus floor elevation </p><br>