Peyronie Disease Clinical Trial
— IPPNANOFATOfficial title:
Novel Nanofat Regenerative Surgical Technique for Peyronies' Disease Treatment With Penile Lenght Conservation and Non-incisional Albuginea Preservation
Verified date | July 2022 |
Source | University of Roma La Sapienza |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Peyronies' disease (PD) is an acquired connective tissue disorder characterized with the growth of fibrous and/or calcified plaques in the tunica albuginea of the penis. The pathogenesis is still unclear, but the most accepted hypothesis is that in genetically prone individuals, trauma or repetitive microtraumas to the erect penis causes inflammation, and consequent growth of fibrous tissue due to degradation of the elastic fibers and fibrin deposition. The fibrous plaques in the tunica albuginea of the penis causes typical signs and symptoms: penile abnormal curvature, penile pain, erectile dysfunction, indentation, loss of girth, shortening of the penis, with significant distress experience and psychological bother. A lot of treatement have been proposed to date but with unsatisfactory results and the surgery results the definitive treatement but with possible risks. Autologous fat grafting was first described by Neuber in 1893 and since then it has developed over the next century. The initial goal of fat grafting was to treat volume losses created by disease or trauma. Further studies done by Zuk et al. in 2001 showed that lipoaspirate contains multipotent adipose stem cells (ADSCs) like in the bone marrow, thereby expanding opportunities in multiple fields. ADSCs have emerged as a key element of regenerative medicine surgery due to their ability to differentiate into a variety of different cell lineages. Moreover, their capacity of paracrine secretion of a broad selection of cytokines, chemokines, and growth factors make them highly clinically attractive. More specific, of particular interest are the anti-apoptotic, anti-inflammatory, proangiogenic, immunomodulatory, and anti-scarring effects that have been demonstrated for ADSCs, which effects on wound healing, soft-tissue restoration and scar remodelling. Nanofat firstly introduced by Tonnard in 2013, is an ultra-purified adipose tissue-derived product that is devoid of mature adipocytes but rich in ADSCs and with regenerative properties. The aim of the study is to investigate the use of nanofat grafting in the treatement of PD.
Status | Recruiting |
Enrollment | 35 |
Est. completion date | August 15, 2022 |
Est. primary completion date | July 15, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Presence of albuginea penile plaque due to Peyronies' disease associated with penile curvature and pain. Normal erectile function. Sexual activity. Exclusion Criteria: - Erectile dysfunction, no sexual activity. |
Country | Name | City | State |
---|---|---|---|
Italy | Antonio Luigi Pastore | Latina |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza |
Italy,
Osmonov D, Ragheb A, Ward S, Blecher G, Falcone M, Soave A, Dahlem R, van Renterghem K, Christopher N, Hatzichristodoulou G, Preto M, Garaffa G, Albersen M, Bettocchi C, Corona G, Reisman Y. ESSM Position Statement on Surgical Treatment of Peyronie's Dise — View Citation
Tonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Degree of curvature | Penile curvature assessment with in-office goniometric angle measurement of a pharmacologically induced erection | Change from Baseline Penile curvature at 6 months | |
Primary | PAIN assessment | Pain wil be assessed by VAT scale | Change from Baseline PAIN (VAS SCORE) at 6 months |
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