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Autologous Hematopoietic Stem Cell Transplantation for Crohn’s Disease
Published in Richard K. Burt, Alberto M. Marmont, Stem Cell Therapy for Autoimmune Disease, 2019
Robert M. Craig, Richard K. Burt
One had so much abdominal pain that she required high doses of opiates. Each had a Crohn’s disease activity index (CDAI) greater that 250 (severe disease). Each had failed therapy with 5-ASA, corticosteroids, antibiotics, azathioprine or methotrexate, and infliximab. One had undergone resection of part of her ileum and colon. The stem cell administration was uneventful in each, and each is in remission in terms of the CDAI (<100 in each; remission < 150),off all medications, including narcotics.
Clinical Studies In Acute and Chronic Inflammation
Published in Siegfried Matzku, Rolf A. Stahel, Antibodies in Diagnosis and Therapy, 2019
Ten (10) patients with refractory Crohn’s disease were enrolled in an open label study of a single infusion of anti-TNF (cA2) (van Dullemen et al., 1995). Eight (8) of the 10 patients exhibited improvement in disease (Crohn’s Disease Activity Index score; colonoscopic evaluation of ulcerations) with the average response duration of 4 months. There were no adverse events related to anti-TNF therapy, however one patient had a “poor response” and one patient had a perforation related to the colonoscopy.
Inflammatory bowel disease
Published in Michael JG Farthing, Anne B Ballinger, Drug Therapy for Gastrointestinal and Liver Diseases, 2019
Elizabeth Carty, Anne B Ballinger
Assessment of disease activity in patients with CD is more difficult than in patients with UC because the clinical pattern and disease complications are more heterogeneous. In clinical trials, disease activity is usually assessed on the basis of symptoms, signs and laboratory markers of inflammatory disease; the most widely used index is the Crohn’s Disease Activity Index (CDAI). Most of these scoring systems are unsuitable for routine clinical use. The working definitions of the American College of Gastroenterology provide a useful guide for routine clinical practice (Table 5.5). There is a poor correlation between clinical activity and endoscopic findings.
Existing and emerging applications for the neuromodulation of nerve activity through targeted delivery of electric stimuli
Published in International Journal of Neuroscience, 2019
Claire Ginn, Bipin Patel, Robert Walker
A human proof-of-concept trial carried out by SetPoint Medical has shown particularly encouraging results. VNS when carried out four times daily was found to significantly reduced TNFα production for up to 84 days [42]. Based on the standard measures of clinical efficacy, including a physician’s assessment and levels of c-reactive protein, 12 of 17 patients demonstrated clinically significant improvements and several reached remission [42]. Treatment was well tolerated and no serious adverse events were reported during this study. SetPoint Medical is now conducting VNS trials in patients with moderate to severe Crohn’s disease, another inflammatory disease. Early reports show promise with six out of eight patients exhibiting a reduced Crohn’s disease activity index score by more than 70 points and an induced clinical and endoscopic improvement with complete remission observed in three patients [43]. This trial is still ongoing and additional patients will need to be studied.
Teduglutide for the treatment of short bowel syndrome – a safety evaluation
Published in Expert Opinion on Drug Safety, 2018
Bharati Kochar, Hans H. Herfarth
Teduglutide was studied in a pilot trial as a modality to treat moderate-to-severe Crohn’s disease [25]. This pilot trial randomized 100 subjects to one of three doses of teduglutide (0.05, 0.10, or 0.20 mg/kg/day) or placebo for 8 weeks. The primary outcome was a decrease in the Crohn’s Disease Activity Index (CDAI) >100 points. Overall, none of the 3 teduglutide dosing regimen met the primary outcome, but there was a trend to higher response and remission rates in the teduglutide arms compared to those on placebo. AEs were reported in 68% of those receiving teduglutide compared to 28% of those in the placebo arm. There were no SAEs. In the teduglutide arm, 21% experienced an AE resulting in drug discontinuation. The most frequently reported AEs were injection site reactions (35%), nausea/vomiting (29%), abdominal distention (19%), and constipation (15%).
The potential role of FDG PET-CT in the characterization of the activity of Crohn’s disease, staging follow-up and prognosis estimation: a pilot study
Published in Scandinavian Journal of Gastroenterology, 2018
Károly Palatka, Sándor Kacska, Szilvia Lovas, Ildikó Garai, József Varga, László Galuska
Crohn’s disease (CD) is a long lasting immune-mediated illness with uncertain etiology. CD is usually a segmental, transmural inflammation of small intestine and colon. The focal FDG accumulation is parallel with immunocell infiltration of bowel wall [1]. Rarely, extraintestinal manifestations, most commonly arthritis and occasionally eye involvement may appear. The initial diagnosis of CD and the assessment of disease activity are based on clinical symptoms, endoscopy with multiple biopsies and histologic investigation, laboratory tests, and imaging examinations [2]. Several laboratory markers may be helpful in the determination of disease activity. In the clinical practice, such inflammatory markers as C-reactive protein (CRP) may be used for characterizing the disease activity in noninvasive way, but specificity of these tests is not satisfactory. To quantify the disease activity, scoring systems such as Crohn’s disease activity index (CDAI) and simple endoscopic score for Crohn’s disease (SES-CD) have been introduced. Unfortunately, clinical and endoscopic scoring systems are indirect, subjective or invasive [3]. Hence objective, noninvasive methods would be necessary to evaluate the biological activity and extent of inflammation in this disease.