Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04750499
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2021-02-08
Brief Title:
Treatment of Perianal Fistulas by Endorectal Advancement Flap Associated With Adipose Tissue Injection
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Treatment of Complex Perianal Fistulas in Patients Without Crohns Disease by Endorectal Advancement Flap Associated With Injection of Autologous and Micro-fragmented Adipose Tissue
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
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:
Fistula_CM1
Brief Summary:
The study aims to evaluate effectiveness of the association of endorectal advancement flap technique with local injection of autologous and micro-fragmented adipose tissue obtained with the Lipogems system in patients with complex Perianal Fistulas not related to Crohns Disease
Detailed Description:
Treatment of anal fistula pursues permanent healing and preservation of anal continence not always easy goals in complex anal fistulas
In patients with Crohns disease simple surgery ligation of the path and suturing of the internal orifice associated with injections of stem cells derived from autologous or allogeneic adipose tissue has been shown to cure up to 70 of the cases Similar results have been obtained in small series of patients with fistulas of cryptoglandular origin and also in rectourethral and rectovaginal fistulas of other etiologies Unfortunately this treatment is time consuming and extremely expensive
Fresh adipose tissue is an alternative source of mesenchymal stem cells MSC with regenerative capabilities immunomodulatory angiogenic and anti-inflammatory effects The injection of fresh adipose tissue obtained by liposuction from the same patient is currently a therapeutic alternative used in regenerative medicine plastic and orthopedic surgery indications as well in other fields Beneficial effects of fresh adipose tissue on anus fistulas and fecal incontinence have also been reported
The aim of the present study is to evaluate the effectiveness of the injection of autologous microfragmented and minimally manipulated adipose tissue associated with a surgical technique that obtains by itself up to 70 cure in order to add the benefits of surgery with those in regenerative medicine hoping that the beneficial effects of MSC will aid in the healing and repair process
A prospective study is proposed in 12 patients with non-Crohns-related complex anals fistulas Whenever possible the endorectal advancement flap technique will be applied in blind fistulas and special cases in which the flap is not indicated alternative techniques will be used In all cases autologous micro-fragmented and minimally manipulated adipose tissue obtained with a standardized procedure previously validated and authorized will be injected This procedure uses the Lipogems device Lipogems International SpA Milan Italy with which a well-characterized adipose tissue is obtained with the maximum safety guarantees
In patients with Crohns disease simple surgery ligation of the path and suturing of the internal orifice associated with injections of stem cells derived from autologous or allogeneic adipose tissue has been shown to cure up to 70 of the cases Similar results have been obtained in small series of patients with fistulas of cryptoglandular origin and also in rectourethral and rectovaginal fistulas of other etiologies Unfortunately this treatment is time consuming and extremely expensive
Fresh adipose tissue is an alternative source of mesenchymal stem cells MSC with regenerative capabilities immunomodulatory angiogenic and anti-inflammatory effects The injection of fresh adipose tissue obtained by liposuction from the same patient is currently a therapeutic alternative used in regenerative medicine plastic and orthopedic surgery indications as well in other fields Beneficial effects of fresh adipose tissue on anus fistulas and fecal incontinence have also been reported
The aim of the present study is to evaluate the effectiveness of the injection of autologous microfragmented and minimally manipulated adipose tissue associated with a surgical technique that obtains by itself up to 70 cure in order to add the benefits of surgery with those in regenerative medicine hoping that the beneficial effects of MSC will aid in the healing and repair process
A prospective study is proposed in 12 patients with non-Crohns-related complex anals fistulas Whenever possible the endorectal advancement flap technique will be applied in blind fistulas and special cases in which the flap is not indicated alternative techniques will be used In all cases autologous micro-fragmented and minimally manipulated adipose tissue obtained with a standardized procedure previously validated and authorized will be injected This procedure uses the Lipogems device Lipogems International SpA Milan Italy with which a well-characterized adipose tissue is obtained with the maximum safety guarantees
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