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IPPNANOFAT
Sponsor study identifier
interventional
35
1 country
1
Study Start
January 1, 2021
Actual (reported)Primary Completion
July 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2021
Actual (reported)March 20, 2022
Actual (reported)April 7, 2022
Actual (reported)July 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
PAIN assessment
Pain wil be assessed by VAT scale
Change from Baseline PAIN (VAS SCORE) at 6 months
Nanofat surgical grafting in albuginea penile tunica
NANOFAT REGENERATIVE SURGICAL GRAFTING IN PRNILE ALBUGIANEA OF PATIENTS AFFECTED BY PEYRONIES' DISEASE
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Antonio Luigi Pastore
Latina, 04100, Italy
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.
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 Disease. Sex Med. 2022 Feb;10(1):100459. doi: 10.1016/j.esxm.2021.100459. Epub 2021 Nov 22.
First Submitted
March 20, 2022
First Posted
April 7, 2022
Study Start
January 1, 2021
Actual (reported)Primary Completion
July 15, 2022
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 8, 2022
Record last verified: 2022-07
Outcomes
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Source: ClinicalTrials.gov.
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