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...
This is a randomized, controlled, parallel study to compare the results of treatment for patients with transsphincteric fistulas-in-ano.
Guidelines for photodynamic therapy (PDT) of actinic keratosis recommend pretreatment with curettage. The impact of curettage on the treatment effect is, however, not known. The present st...
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...
Aortic valve insufficiency can be addressed during continuous-flow left ventricular assist device (CF-LVAD) implantation by performing aortic valve repair or replacement, or patch closure of the left ...
Plant hormones play important roles in regulating every aspect of growth, development, and metabolism of plants. We are interested in understanding hormonal regulation of floret opening and closure in...
This study compared the efficacy of a percutaneous transhepatic cholangioscopy (PTCS) catheter and a fully covered self-expandable metal stent (FCSEMS) for maintaining biliary tract patency after magn...
To determine the efficacy of a new surgical technique involving use of a contralateral autologous internal limiting membrane (ILM) free flap for closure of a refractory macular hole (MH).
Patients with Crohn disease-related anal fistulas are treated with debridement of fistulous tracts and the placement of noncutting setons (NCSs). However, to reduce the high recurrence rate, there is ...
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...