Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04670276
Status:
UNKNOWN
Last Update Posted:
2020-12-17
First Post:
2020-12-03
Brief Title:
Conservative Treatment of Gastrointestinal Fistulas by Endoscopic Injection of tSVFem
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Conservative Treatment of Gastrointestinal Fistulas by Endoscopic Injection of Emulsified Adipose Tissue Stromal Vascular Fraction tSVFem
Status:
UNKNOWN
Status Verified Date:
2020-12
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:
tSVFem
Brief Summary:
Gastrointestinal GI fistula is a complex condition with high mortality and requiring a multidisciplinary management
The aim of this study is to exploit the regenerative-tissue capacities of autologous emulsified adipose tissue-derived stromal vascular fraction tSVFem widely used in other medical fields - like plastic surgery -for different purposes harvested and delivered locally by endoscopy to close the GI fistula
The proposed technique for the treatment of GI fistulas with tSVFem requires a minimal inexpensive easily reproducible mechanical manipulation of autologous adipose tissue without necessity of any enzymatic digestion or cell expansion
The aim of this study is to exploit the regenerative-tissue capacities of autologous emulsified adipose tissue-derived stromal vascular fraction tSVFem widely used in other medical fields - like plastic surgery -for different purposes harvested and delivered locally by endoscopy to close the GI fistula
The proposed technique for the treatment of GI fistulas with tSVFem requires a minimal inexpensive easily reproducible mechanical manipulation of autologous adipose tissue without necessity of any enzymatic digestion or cell expansion
Detailed Description:
Gastrointestinal fistula may be a life-threatening condition caused by several types of injuries iatrogenic traumatic post-operative requiring complex and multidisciplinary management To date no clear guidelines have been drawn up for the treatment that may include a conservative minimally invasive or major surgical approach depending on the patients specific clinical characteristics Furthermore patients with fistulas are often fragile and surgical treatments are highly risky and invasive Less invasive treatments such as stenting endoluminal endoscopic vacuum therapy and suturing are widely employed but these treatments often require long hospitalization highly skilled operators without certain results and with high rates of complications
The aim of this study is to exploit the regenerative-tissue capacities of autologous emulsified adipose tissue-derived stromal vascular fraction tSVFem widely used in other medical fields - like plastic surgery -for different purposes harvested and delivered locally by endoscopy to close the GI fistula Indeed the anti-inflammatory and regenerative-tissue promoting effects of tSVFem may safely promote rapid and effective tissue healing as alternative and in this setting they were not investigated before Fistulas are often long-standing chronic conditions thus healing mechanisms are delayed and subverted in favor of inflammation and fibrosis resembling chronic inflammatory diseases Delivery of tSVFem is a promising new approach that promotes healing in virtue of its immunosuppressive immunomodulatory pro-angiogenic and regenerative potentials Since the grafted material used in this study is autologous there is no risk for rejection All the procedures are performed under general anesthesia with orotracheal intubation or laryngeal mask Approximately 30 cc of fat are harvested from the superficial layer of subcutaneous tissue by a 21 mm microcannula with 4 1-mm size holes arranged in a single raw to get the so-called microfat Twenty cc of the harvested microfat are mechanical emulsified by sequential passages through 24mm and 12mm filters and a 600400 μm disposable filtering device
Then the material is centrifuged at 3000 rounds for three minutes obtaining the tSVFem after removal of supernatant fraction and oil released upon mature adipocytes mechanical disruption
Subsequently an endoscopy is performed to inject 10 cc of microfat into the fistula through a 6-French catheter until it was completely filled Then with a 22 Gauge endoscopic needle a total of 1-2 cc of tSVFem were injected into the submucosa of the 4 quadrants of the fistula borders to obliterate it completely
A radiologic and endoscopic control at day-7 is done to evaluate complete healing of the fistula
The technique proposed by the investigators for the treatment of GI fistulas with tSVFem requires a minimal inexpensive easily reproducible mechanical manipulation of autologous adipose tissue without necessity of any enzymatic digestion or cell expansion
The aim of this study is to exploit the regenerative-tissue capacities of autologous emulsified adipose tissue-derived stromal vascular fraction tSVFem widely used in other medical fields - like plastic surgery -for different purposes harvested and delivered locally by endoscopy to close the GI fistula Indeed the anti-inflammatory and regenerative-tissue promoting effects of tSVFem may safely promote rapid and effective tissue healing as alternative and in this setting they were not investigated before Fistulas are often long-standing chronic conditions thus healing mechanisms are delayed and subverted in favor of inflammation and fibrosis resembling chronic inflammatory diseases Delivery of tSVFem is a promising new approach that promotes healing in virtue of its immunosuppressive immunomodulatory pro-angiogenic and regenerative potentials Since the grafted material used in this study is autologous there is no risk for rejection All the procedures are performed under general anesthesia with orotracheal intubation or laryngeal mask Approximately 30 cc of fat are harvested from the superficial layer of subcutaneous tissue by a 21 mm microcannula with 4 1-mm size holes arranged in a single raw to get the so-called microfat Twenty cc of the harvested microfat are mechanical emulsified by sequential passages through 24mm and 12mm filters and a 600400 μm disposable filtering device
Then the material is centrifuged at 3000 rounds for three minutes obtaining the tSVFem after removal of supernatant fraction and oil released upon mature adipocytes mechanical disruption
Subsequently an endoscopy is performed to inject 10 cc of microfat into the fistula through a 6-French catheter until it was completely filled Then with a 22 Gauge endoscopic needle a total of 1-2 cc of tSVFem were injected into the submucosa of the 4 quadrants of the fistula borders to obliterate it completely
A radiologic and endoscopic control at day-7 is done to evaluate complete healing of the fistula
The technique proposed by the investigators for the treatment of GI fistulas with tSVFem requires a minimal inexpensive easily reproducible mechanical manipulation of autologous adipose tissue without necessity of any enzymatic digestion or cell expansion
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