Peyronie DiseaseIPPNANOFATNCT05316714
Novel Nanofat Regenerative Surgical Technique for Peyronies' Disease Treatment
A study testing Nanofat grafing in people with Peyronie Disease, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Peyronie Disease
- What is being tested?
- Nanofat grafing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 15 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of albuginea penile plaque due to Peyronies' disease associated with penile curvature and pain. Normal erectile function. Sexual activity.
Who cannot join
- Erectile dysfunction, no sexual activity.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Antonio Luigi Pastore
Latina, 04100
Antonio Luigi Pastore, Prof, MD, PhD, 3401138648 ext. 0039, antopast@hotmail.com
About this study
Official title: Novel Nanofat Regenerative Surgical Technique for Peyronies' Disease Treatment With Penile Lenght Conservation and Non-incisional Albuginea Preservation
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.
Read more
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.
Read the 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. Peyronie's "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.
- Conditions
- Peyronie Disease
- Being tested
- Nanofat grafing
- Medical subject headings
- Penile Induration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanofat grafingProcedure or surgery
NANOFAT REGENERATIVE SURGICAL GRAFTING IN PRNILE ALBUGIANEA OF PATIENTS AFFECTED BY PEYRONIES' DISEASE
| Study group | Role | What they receive |
|---|---|---|
| IPP Nanofat Grafting | Experimental | Nanofat surgical grafting in albuginea penile tunica Receives: Procedure: Nanofat grafing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of curvature
Penile curvature assessment with in-office goniometric angle measurement of a pharmacologically induced erection
Measured: Change from Baseline Penile curvature at 6 months
PAIN assessment
Pain wil be assessed by VAT scale
Measured: Change from Baseline PAIN (VAS SCORE) at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Jan 2021
- Primary completion15 Jul 2022 (estimated)
- Study completion15 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peyronie DiseaseStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Luigi Pastore, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316714
- Sponsor's protocol ID
- IPP_2022_NanoFAT
- Acronym
- IPPNANOFAT
- Status last verified
- Jul 2022
- First submitted
- 20 Mar 2022
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Outcomes
Publications
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.
PubMed 23783059Osmonov 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.
PubMed 34823053
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Nanofat Regenerative Surgical Technique for Peyronies' Disease Treatment With Penile Lenght Conservation and Non-incisional Albuginea Preservation
- ClinicalTrials.gov ID
- NCT05316714
- Acronym / sponsor ID
- IPPNANOFAT / IPP_2022_NanoFAT
- Conditions
- Peyronie Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 15 Aug 2022 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. Peyronie's "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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPP Nanofat Grafting | Experimental | Procedure: Nanofat grafingNanofat surgical grafting in albuginea penile tunica |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of albuginea penile plaque due to Peyronies' disease associated with penile curvature and pain. Normal erectile function. Sexual activity.
Key exclusion criteria (1 listed)
- Erectile dysfunction, no sexual activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanofat grafingNANOFAT REGENERATIVE SURGICAL GRAFTING IN PRNILE ALBUGIANEA OF PATIENTS AFFECTED BY PEYRONIES' DISEASE | Procedure or surgery | IPP Nanofat Grafting |
Primary outcome
Degree of curvature
Time frame: Change from Baseline Penile curvature at 6 months
Penile curvature assessment with in-office goniometric angle measurement of a pharmacologically induced erection
PAIN assessment
Time frame: Change from Baseline PAIN (VAS SCORE) at 6 months
Pain wil be assessed by VAT scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Results publication: PubMed 23783059Tonnard 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.
- Results publication: PubMed 34823053Osmonov 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.
- Individual participant dataSharing planned: No. Outcomes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanofat grafing in people with Peyronie Disease, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of curvature (time frame: Change from Baseline Penile curvature at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05316714, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.