Track topics on Twitter Track topics that are important to you
In a dose escalation study we will determine the safety and preliminary efficacy of allogeneic bone marrow mesenchymal stem cells (bmMSCs) in the induction of response for active fistulizing Crohn's Disease (CD).
Despite the introduction of anti-TNFa (tumor necrosis factor alpha) therapy, perianal disease still accounts for a high rate of morbidity in patients diagnosed with CD. Recently, a phase II multicenter randomized study was reported showing that expanded adipose tissue derived mesenchymal stem cells (atMSCs) in combination with fibrin glue was an effective and safe treatment for complex perianal fistula. However, dose escalation of allogeneic bone marrow (bm) MSCs for the local treatment of perianal fistulas has not been studied.
In this study, three escalating doses will be tested in a total of three cohorts. MSC implantation will be preceded by surgical localization, curettage of the fistulous tract and closure of the internal opening. Per cohort, patients will be randomized in a 5:2 fashion to receive either 10x10^6 (cohort 1), 30x10^6 (cohort 2) or 90x10^6 (cohort 3) bmMSCs or no cells (control group).
The primary endpoint will be assessed at week 12: i) the number of adverse and serious adverse events and ii) a reduction in the number of draining fistulas, which is defined as absence of discharge and absence of collections of ≥2 cm directly related to the treated fistulas tracts as measured by MRI.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Localization, curettage of the fistulous tract and closure of the internal opening without MSC injection., Localization, curettage of the fistulous tract and closure of the internal opening with local MSC injection.
Leiden University Medical Center (LUMC)
Leiden University Medical Center
Published on BioPortfolio: 2014-08-27T03:12:54-0400
We aim to assess the efficacy of the Curaseal anal plug in patients with idiopathic uncomplicated fistulous tracts. Healing of the fistula tract will be assessed both clinically and radiol...
The goal of this study is to assess whether wound closure with skin adhesive or running stitches combined with skin adhesive will be superior to standard wound sutures. This is a split-wou...
Investigator will examined the diagnostic effect of the endometrial washing by saline. Because this technique more less painful and easier compared to endometrial curettage. Participants w...
This study comprises a prospective study of 40 patients with transphincteric anal fistula. The patients were classified into two groups: Group I: Fistulectomy, closure of internal sphincte...
The main goal of this study is to describe the trends in the incidence rate of internal hernia presentation after different modifications of the mesenteric closure technique after primary ...
Recent studies described that in approximately 14% to 16% of cases of macular holes treated with the inverted internal limiting membrane flap technique, the hole was closed only by a thin layer of inv...
Rectovaginal fistula after rectal cancer resection is an uncommon complication. Complex approaches and different surgical techniques have been proposed to treat it. The technique we present here uses ...
To investigate the mechanism of macular hole (MH) closure following the inverted internal limiting membrane (ILM) technique.
Periplasmic Binding Proteins (PBPs) trap nutrients for their internalization into bacteria by ABC transporters. Ligand binding triggers PBP closure by bringing its two domains together like a Venus fl...
As the challenge for finding the best abdominal incision closure technique continues, surgeons are aiming to minimize postoperative wound complications such as wound dehiscence and hernia as an acute ...
Presence of air or gas within the intracranial cavity (e.g., epidural space, subdural space, intracerebral, etc.) which may result from traumatic injuries, fistulous tract formation, erosions of the skull from NEOPLASMS or infection, NEUROSURGICAL PROCEDURES, and other conditions.
The region of the STOMACH at the junction with the DUODENUM. It is marked by the thickening of circular muscle layers forming the pyloric sphincter to control the opening and closure of the lumen.
Compounds that either stimulate the opening or prevent closure of EPITHELIAL SODIUM ION CHANNELS.
A method of stopping internal bleeding or blood flow, or the closure of a wound or body cavity, achieved by applying pressure or introducing an absorbent liquid, gel, or tampon.
A scraping, usually of the interior of a cavity or tract, for removal of new growth or other abnormal tissue, or to obtain material for tissue diagnosis. It is performed with a curet (curette), a spoon-shaped instrument designed for that purpose. (From Stedman, 25th ed & Dorland, 27th ed)
Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...
Track and monitor developments in stem cell research and commercial development. Follow the tabs above to read the latest global news, research, clinical trials on stem cells and follow companies active in the stem cell industry. BioPort...