Trials / Completed
CompletedNCT03431779
Lipofilling as a Treatment for Vestibulodynia
Adipose Derived Stem Cell Transplantation Via Lipofilling for Vestibulodynia: a Controlled Intervention Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- University Hospital, Ghent · Academic / Other
- Sex
- Female
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The investigators would like to investigate if lipofilling with its adipose derived stem cells (ADSC) could be a new, less invasive but equally or more effective therapeutic option for women with vestibulodynia than vestibulectomy. The investigators expect the study to be successful because of the anti-inflammatory effects of the ADSC and its effectiveness -although not thoroughly studied- in some neuropathic pain disorder like pudendal neuralgia or post mastectomy pain syndrome. Method: A controlled intervention study: one group receiving golden standard therapy 'vestibulectomy' and one group receiving vestibular lipofilling.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Adipose derived stem cell transplantation via lipofilling | Liposuction of 60cc abdominal fat with its adipose derived stem cells which will be reinjected (10-20 cc) in the vestibular area after centrifugation for 3 minutes at 1000 rpm and decantation of oil and red blood cells. |
| PROCEDURE | Surgical excision | Excision of painful areas |
Timeline
- Start date
- 2018-04-17
- Primary completion
- 2021-05-14
- Completion
- 2023-05-31
- First posted
- 2018-02-13
- Last updated
- 2023-07-17
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT03431779. Inclusion in this directory is not an endorsement.