Novel Nanofat Regenerative Surgical Technique for Peyronies' Disease Treatment

NCT05316714 | Unknown DMC

• 1 other identifier: IPP_2022_NanoFAT
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peyronie Disease

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

IPP Nanofat Grafting

EXPERIMENTAL

Nanofat surgical grafting in albuginea penile tunica

Procedure: Nanofat grafing

Interventions

Nanofat grafing PROCEDURE

NANOFAT REGENERATIVE SURGICAL GRAFTING IN PRNILE ALBUGIANEA OF PATIENTS AFFECTED BY PEYRONIES' DISEASE

IPP Nanofat Grafting

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of albuginea penile plaque due to Peyronies' disease associated with penile curvature and pain. Normal erectile function. Sexual activity.

You may not qualify if:

• Erectile dysfunction, no sexual activity.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Antonio Luigi Pastore

Latina, 04100, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 23783059 RESULT

• 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.

  PMID: 34823053 RESULT

MeSH Terms

Conditions

Penile Induration

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: April 7, 2022
• Study Start: January 1, 2021
• Primary Completion: July 15, 2022
• Study Completion: August 15, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)