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The purpose of this extension is to investigate and confirm the long-term (6 months) safety and efficacy of the preceding FATT-1 trial [ClinicalTrials.gov identifier: NTC00475410], which studied patients with perianal fistula treated having received adipose-derived adult stem cell (ASC)and/or fibrin glue.
The biological properties of stem cells derived from adult tissues make them candidates for the treatment of pathologies requiring tissue regeneration or in diseases where the healing process is altered.
This study aims to evaluate the safety and efficacy of patients having participated within a preceding multicenter, placebo-controlled, phase 3 study [ClinicalTrials.gov identifier: NTC00475410]. The present extension aims to collect safety and efficacy data for up to 12 month from initial administration.
Fistula closure is defined as absence of suppuration through the external orifice with complete re-epithelization of the external orifice and absence of collections >2cm directly related to the fistula tract treated, as measured by MRI.
Time Perspective: Prospective
Complex Perianal Fistula
ASCs, Fibrin glue, ASCs
Hospital Mutua de Terrasa
Published on BioPortfolio: 2014-08-27T03:17:43-0400
This comparative, multicentre, randomised clinical trial is designed with two parallel groups that will follow a treatment either with an autologous implant of ASCs (Adipose Derived Stem C...
Anal fistula is defined as an abnormal communication between the anal canal and the perianal skin. Adipose-derived stem cells are a new therapy for the closure of these fistulas. This stud...
Crohn's disease is an immunologically mediated inflammatory bowel disease with a reported incidence of 4.0-7.0, 7.1, and 1.34 per 100,000 persons in Europe, the U.S., and Korea, respective...
Surgical treatment of perianal fistulas frequently affects fecal continence. Sphincter saving techniques like loose or cutting seton and fistulectomy with advancement of an endorectal flap...
This multicenter, randomized, controlled trial was conducted by the Groupe d'Etude Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID) to evaluate the efficacy and safet...
Recently, adipose-derived stem cells (ASCs), obtained from fresh human lipoaspirate, have shown promise as immunomodulatory agents having demonstrated immunosuppressive functionality both in vitro and...
Obese women diagnosed with breast cancer have an increased risk for metastasis, and the underlying mechanisms are not well established. Within the mammary gland, adipose-derived stromal cells (ASCs) a...
The research and application of regeneration medicine will require a reliable source of stem cells. Adipose tissue has proven to be an easily accessible and rich source of adult stem cells, termed adi...
Since the 1980s, adipose-derived stem cells (ASCs) have become a powerful and potential source for stem cell-based therapy, regenerative medicine, and even drug delivery in cancer treatment. The devel...
Vascular smooth muscle cells (VSMCs) play essential roles in regulating blood vessel form and function and they are required for vascular tissue regeneration. Multipotent adipose derived stromal cells...
An abnormal anatomical passage between the INTESTINE, and another segment of the intestine or other organs. External intestinal fistula is connected to the SKIN (enterocutaneous fistula). Internal intestinal fistula can be connected to a number of organs, such as STOMACH (gastrocolic fistula), the BILIARY TRACT (cholecystoduodenal fistula), or the URINARY BLADDER of the URINARY TRACT (colovesical fistula). Risk factors include inflammatory processes, cancer, radiation treatment, and surgical misadventures (MEDICAL ERRORS).
An abnormal anatomical passage that connects the VAGINA to other organs, such as the bladder (VESICOVAGINAL FISTULA) or the rectum (RECTOVAGINAL FISTULA).
Glycosylated proteins which are part of the salivary glue that Drosophila larvae secrete as a means of fixing themselves to an external substrate for the duration of the pre-pupal and pupal period.
A fistula between the maxillary sinus and the oral cavity.
Agents that affect the function of FIBRIN in BLOOD COAGULATION. They used as COAGULANTS for HEMORRHAGE or ANTICOAGULANTS for THROMBOSIS.
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...