Track topics on Twitter Track topics that are important to you
Using scintigraphic imaging including planar scintigraphy and SPECT, this study will evaluate the utility of two different ex vivo 99mTc-HMPAO labelled mononuclear cell populations in order to select the optimal methodology (using PBMC or purified lymphocyte subpopulations) for future drug intervention studies in Crohn's disease.
Two parallel exploratory approaches will be investigated to enrich for lymphocyte populations expressing leukocyte trafficking inhibitors. In the first, whole blood will be fractionated on a ficoll gradient to purify a heterogeneous population of all the peripheral blood mononuclear cells (PBMC) for labelling. Secondly, further enrichment will be attempted using depletion of PBMC fractions of monocytes and B cells.
This study is based on the established technology of scintigraphic 'white cell scanning', in which the leukocytes in a limited volume of patient's blood are radiolabeled with indium-111 or technetium-99m, re-introduced into the circulation, and their subsequent trafficking and accumulation in areas of active inflammation is visualised by scintigraphic imaging. This methodology is routinely used for diagnosis of inflammatory conditions and pharmacodynamic changes have been documented in the literature. As it is intended that this technology could be used in future drug intervention studies.
However, because this sub-population labelling methodology remains exploratory, this study will investigate the utility of such techniques for use in future clinical trials in Crohn's patients.
Two parallel exploratory approaches will be investigated to enrich for lymphocyte populations expressing leukocyte trafficking inhibitors. In the first, whole blood will be fractionated on a ficoll gradient to purify a heterogeneous population of all the peripheral blood mononuclear cells (PBMC) for labelling. Secondly, T lymphocytes will be further enriched by depletion of monocytes and B cells from PBMC fractions. In part A one scintigraphy scan will be performed in healthy volunteers to confirm that the purification and labelling procedure does not show abnormal biodistribution compared to the known physiological distribution of labelled mononuclear cells [Bennink, 2008].
In part B, Crohn's disease patients will then be recruited to undergo two scintigraphy scans 48 hours apart to establish intra-patient variability and feasibility of the repeated procedure that will be used in subsequent studies for therapeutic intervention. Analysis of SPECT images will be performed using a standardized scoring system.
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
GSK Investigational Site
Published on BioPortfolio: 2014-08-27T03:16:33-0400
Crohn's disease (CD) is an autoimmune disorder which affects over 700,000 people in the U.S. The disease can vary in severity and multiple drug classes are available to the disease depend...
The purpose of this study will permit to determine the role of FDG PET/CT to diagnose Crohn Disease and recurrence of Crohn disease after having compared results of PET/CT's with results o...
Patients with moderately to severely active Crohn's disease will be treated with oral CP-461 200 mg (2 x 100 mg capsules) twice-daily for 8 weeks. The purpose of this study is to see if C...
Crohn's disease reduces fertility by inducing inflammation both directly and in the fallopian tubes and ovaries and indirectly through surgical interventions and tubal adhesions associated...
Crohn's disease is a chronic inflammatory disorder of the gastrointestinal tract. The origin of Crohn's disease remains unknown and there is no curative therapy, either medical or surgica...
Patients with Crohn's disease undergoing ileocolectomy and primary anastomosis are often at increased risk of anastomotic leak. We aimed to determine whether diverting ileostomy was protective against...
It is well known that Crohn's disease is a risk factor for the development of small bowel adenocarcinoma. However, the association between Crohn's disease-associated small bowel adenocarcinoma and sur...
Mucosal healing is important in Crohn's disease therapies. Epithelial homeostasis becomes dysregulated in Crohn's, with increased permeability, inflammation, and diarrhoea. MicroRNAs are small non-cod...
Systemic molecular mediators of inflammation differentiate between Crohn's disease and ulcerative colitis, implicating threshold levels of IL-10 and relative ratios of pro-inflammatory cytokines in therapy.
Faecal diversion is associated with improvements in Crohn's disease but not ulcerative colitis, indicating differing mechanisms mediate the diseases. This study aimed to investigate levels of systemic...
A chronic transmural inflammation that may involve any part of the DIGESTIVE TRACT from MOUTH to ANUS, mostly found in the ILEUM, the CECUM, and the COLON. In Crohn disease, the inflammation, extending through the intestinal wall from the MUCOSA to the serosa, is characteristically asymmetric and segmental. Epithelioid GRANULOMAS may be seen in some patients.
A condition characterized by persistent or recurrent labial enlargement, ORAL ULCER, and other orofacial manifestations in the absence of identifiable CROHN DISEASE; or SARCOIDOSIS. There is no consensus on whether orofacial granulomatosis is a distinct clinical disorder or an initial presentation of Crohn disease.
Techniques for labeling a substance with a stable or radioactive isotope. It is not used for articles involving labeled substances unless the methods of labeling are substantively discussed. Tracers that may be labeled include chemical substances, cells, or microorganisms.
Chronic, non-specific inflammation of the GASTROINTESTINAL TRACT. Etiology may be genetic or environmental. This term includes CROHN DISEASE and ULCERATIVE COLITIS.
A chimeric monoclonal antibody to TNF ALPHA that is used in the treatment of RHEUMATOID ARTHRITIS; ANKYLOSING SPONDYLITIS; PSORIATIC ARTHRITIS and CROHN'S DISEASE.
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Crohn's Disease (CD)
Crohn’s disease (CD) is a long-term condition that causes inflammation of the lining of the digestive system. Inflammation can affect any part of the digestive system, from the mouth to the back passage, but most commonly occurs in the last s...