NL-OMON48736
Not yet recruiting
Not Applicable
Injection of Autologous Stromal Vascular Fraction enriched lipoaspirate for the treatment of vulvar Lichen Sclerosus - a pilot study - Injection of aSVF enriched lipoaspirate for vulvar Lichen Sclerosus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversitair Medisch Centrum Groningen
- Enrollment
- 15
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Postmenopausal women up to 80 years with ASA Physical Status Classification 0\-1
- •\- Histopathological confirmed diagnosis of lichen sclerosus
- •\- Moderate or severe lichen sclerosus (IGA scale 3 or 4\), therapy resistant to conventional therapy with highly potent topical steroids (insufficient reduction in clinical symptoms and signs having used topical steroids for 6 months).
Exclusion Criteria
- •\- Women with history of vulvar cancer or vulva intraepitheliale neoplasie (VIN) in addition to lichen sclerosus
- •\- An oncological event in the patient\*s history \< 5 years ago.
- •\- A known systemic disease that will impair wound healing (e.g. diabetes mellitus type I, known atherosclerosis with an event that required hospitalization, collagen diseases, diseases of the skin, HIV).
- •\- Systematic use of prednisone or other immunotherapy
- •\- Use of anticoagulant therapy
Outcomes
Primary Outcomes
Not specified
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Phase 1
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