Ignite Creation Date:
2024-05-06 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05316714
Status:
UNKNOWN
Last Update Posted:
2022-07-08
First Post:
2022-03-20
Brief Title:
Novel Nanofat Regenerative Surgical Technique for Peyronies Disease Treatment
Sponsor:
University of Roma La Sapienza
Organization:
University of Roma La Sapienza
Study Overview
Official Title:
Novel Nanofat Regenerative Surgical Technique for Peyronies Disease Treatment With Penile Lenght Conservation and Non-incisional Albuginea Preservation
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPPNANOFAT
Brief Summary:
Peyronies disease PD is an acquired connective tissue disorder characterized with the growth of fibrous andor 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
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
Detailed Description:
The etiology of PD remains uncertain but is well accepted that there is a chronic inflammation of tunica albuginea and this reflect perturbations in normal wound healing and aberrant deposition of extracellular matrix components in the soft tissue of the penis
There appears to be significant pathophysiologic and genetic overlap of PD with other superficial fibrosing disorders such as Dupuytren disease palmar fibromatosis and Ledderhose disease plantar fibromatosis but not with more diffuse conditions such as systemic sclerosis Since PD was discovered a lot of treatment were proposed In the acute stage of PD treatments aim to alleviate penile pain and minimise disease progression and treatement attempts to mitigate inflammation oral intralesional injection topical treatement were used but with few non significant results
In the chronic phase surgical treatments aims to correct the curvature but with not a few negative implications include penile shortening erectile dysfunction glans hypoaesthesia residual or recurrent curvature and palpable or uncomfortable suture knots below the skin
Recent findings on scar biology explain some factors that influence pro-fibrotic pathways Preventions and treatment strategies mainly focus on reducing inflammation and hypoxia Emerging therapies shows that Mesenchymal stem cells MSCs have immunomodulatory and antifibrotic effects by secreting paracrine growth factors
Zuk et al in 2001 and 2002 showed that lipoaspirate contains multipotent adipose stem cells ADSCs population comparable to that isolated from the bone marrow Because of its availability and accessibility white adipose tissue is considered a stem cell depot Nanofat grafting technique firstly reported by Tonnard is an ultra-purified adipose tissue-derived product that is devoid of mature adipocytes but contains rich in ADSCs microvascular fragments growth factors vascular endothelial growth factor VEGF platelet-derived growth factor PDGF hepatocyte growth factor HGF transforming growth factor-beta TGF-β basic fibroblast growth factor bFGF insulin-like growth factor 1 IGF-1 and granulocyte-macrophage colony-stimulating factor GM-CSF biological peptides lipoxins resolvins protectins neurotrophic factors angiogenin matrix metalloproteinase leukemia inhibitory factor and macrophage migration inhibitory factor and cytokines It is a liquefied autologous injectable product with the property of biological integration with adjacent cells and tissues due to its homogenous consistency At the site of injury these stromal cells initiate a site-specific reparative response comprised of remodeling of extracellular matrix enhanced and sustained angiogenesis immune system modulation and cellular turnover These properties of stromal cells provide a platform for the usage of cellular therapy in various diseases Peyronies plaque is a scarred tissue results from abnormal extracellular matrix production through upregulation of myofibroblast activity and tissue inhibitors of matrix metalloproteinases among other mechanisms The aim of the study is to investigate the possible therapeutic role of nanofat grafting in the treatement of PD
There appears to be significant pathophysiologic and genetic overlap of PD with other superficial fibrosing disorders such as Dupuytren disease palmar fibromatosis and Ledderhose disease plantar fibromatosis but not with more diffuse conditions such as systemic sclerosis Since PD was discovered a lot of treatment were proposed In the acute stage of PD treatments aim to alleviate penile pain and minimise disease progression and treatement attempts to mitigate inflammation oral intralesional injection topical treatement were used but with few non significant results
In the chronic phase surgical treatments aims to correct the curvature but with not a few negative implications include penile shortening erectile dysfunction glans hypoaesthesia residual or recurrent curvature and palpable or uncomfortable suture knots below the skin
Recent findings on scar biology explain some factors that influence pro-fibrotic pathways Preventions and treatment strategies mainly focus on reducing inflammation and hypoxia Emerging therapies shows that Mesenchymal stem cells MSCs have immunomodulatory and antifibrotic effects by secreting paracrine growth factors
Zuk et al in 2001 and 2002 showed that lipoaspirate contains multipotent adipose stem cells ADSCs population comparable to that isolated from the bone marrow Because of its availability and accessibility white adipose tissue is considered a stem cell depot Nanofat grafting technique firstly reported by Tonnard is an ultra-purified adipose tissue-derived product that is devoid of mature adipocytes but contains rich in ADSCs microvascular fragments growth factors vascular endothelial growth factor VEGF platelet-derived growth factor PDGF hepatocyte growth factor HGF transforming growth factor-beta TGF-β basic fibroblast growth factor bFGF insulin-like growth factor 1 IGF-1 and granulocyte-macrophage colony-stimulating factor GM-CSF biological peptides lipoxins resolvins protectins neurotrophic factors angiogenin matrix metalloproteinase leukemia inhibitory factor and macrophage migration inhibitory factor and cytokines It is a liquefied autologous injectable product with the property of biological integration with adjacent cells and tissues due to its homogenous consistency At the site of injury these stromal cells initiate a site-specific reparative response comprised of remodeling of extracellular matrix enhanced and sustained angiogenesis immune system modulation and cellular turnover These properties of stromal cells provide a platform for the usage of cellular therapy in various diseases Peyronies plaque is a scarred tissue results from abnormal extracellular matrix production through upregulation of myofibroblast activity and tissue inhibitors of matrix metalloproteinases among other mechanisms The aim of the study is to investigate the possible therapeutic role of nanofat grafting in the treatement of PD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None