Crohn's Disease Stem Cell Transplantation
Crohn's DiseaseCrohn's disease (CD) is a chronic illness, immunologically mediated, probably induced by the exposure of the intestine to an antigen or antigens similar to the intestine, to which immunologic tolerance is lost or a dysregulated immunity ensues. The disease has a variable course, from a mild, intermittently active illness requiring only symptomatic therapy to a fulminant illness requiring potentially dangerous immunosuppressive therapy, surgery or both. The molecular defect causing CD has not been characterized, but probably involves aberrant T cell function. Although CD often responds to immunosuppressive medication including corticosteroids, azathioprine and 6-mercaptopurine, to anti inflammatory drugs such as 5 aminosalicylate (5 ASA), or to some antimicrobial agents, including metronidazole, no therapy has been curative. In patients with severe CD, who have been unresponsive to corticosteroids, azathioprine, 5 ASA, metronidazole, and infliximab, we propose to compare the efficacy of Crohn's disease non-myeloablative autologous hematopoietic stem cell transplantation (CDNST) to standard therapy. Subsequent disease activity will be followed by (1) Crohn's disease activity index (CDAI), (2) a more global severity index, the Crohn's Severity Index, (3) type and amount of therapy for CD, and (4) clinical, hematologic and biochemical studies.
Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator
Inflammatory Bowel DiseaseUlcerative Colitis1 moreThe immunogenicity of anti-tumor necrosis factor alpha (anti-TNF) therapy in inflammatory bowel disease (IBD) is an important cause of loss of response to therapy that may lead to escalation of dose or discontinuation of therapy. Antibodies may develop to infliximab (ATI) or to adalimumab (ATA) and cause this loss of response, also known as a secondary loss of response. An alternative approach is the addition of immunomodulator (IM) therapy to counteract the antibody response and regain efficacy of the biologic medication. The investigators' goal is to treat patients' who have lost response to adalimumab or infliximab with an immunomodulator with the goal of eliminating the circulating antibodies to the anti-TNF and restoring efficacy.
A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
Crohn's DiseaseThe purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study. The GED-0301-CD-003 trial was not initiated; see detailed description.
Corticosteroid Dosage for Crohn's Disease Flare
Crohn's DiseaseInflammatory Bowel DiseaseProspective randomized comparative effectiveness trial designed to compare fixed dosing and weight-based dosing of corticosteroids in patients with Crohn's disease flares.
The Impact of Vitamin D on Disease Activity in Crohn's Disease
Crohn DiseaseThe purpose for this study is to determine the effect of vitamin D supplementation on disease activity in Crohn's disease patients in Canada and Saudi Arabia
Mesenchymal Stem Cell Therapy for the Treatment of Severe or Refractory Inflammatory and/or Autoimmune...
Crohn's DiseaseThis project aims to assess safety and efficacy of allogeneic Mesenchymal stem Cell (MSC) in Crohn's disease refractory or intolerant to conventional therapies. Twenty patients with active refractory Crohn's disease defined by a Crohn's Disease Activity Index (CDAI) > 220 despite conventional treatment will be included over 4 years in this phase I-II trial. This will be a pilot open label trial. Patients will be treated with 2 successive injections of allogeneic MSC at baseline and 4 weeks later. Patients will be followed up at weeks 2, 4, 8 and 12.
Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate...
Crohn's DiseaseThe purpose of this study is to evaluate the efficacy and safety of ontamalimab as maintenance treatment in participants with moderate to severe Crohn's disease (CD).
The French E3N Prospective Cohort Study
Breast CancerColo-rectal Cancer12 moreThe French E3N cohort was initiated in 1990 to investigate the risk factors associated with cancer and other major non-communicable diseases in women. The participants were insured through a national health system that primarily covered teachers, and were enrolled from 1990 after returning baseline self-administered questionnaires and providing informed consent. The cohort comprised nearly 100 000 women with baseline ages ranging from 40 to 65 years. Follow-up questionnaires were sent approximately every 2-3 years after the baseline and addressed general and lifestyle characteristics together with medical events (cancer, cardiovascular diseases, diabetes, depression, fractures and asthma, among others). The follow-up questionnaire response rate remained stable at approximately 80%. A biological material bank was generated and included blood samples collected from 25 000 women and saliva samples from an additional 47 000 women. Ageing among the E3N cohort provided the opportunity to investigate factors related to agerelated diseases and conditions as well as disease survival.
Body Composition in Children With Inflammatory Bowel Disease
Crohn's DiseaseUlcerative ColitisBackground: Growth impairment is commonly seen in children diagnosed with inflammatory bowel diseases (IBD), mainly those with Crohn's disease (CD). There is general consensus in the literature that body composition, composed of fat mass and lean mass is altered in children with IBD compared with controls. Evidence regarding the effect of different therapeutic approaches on body composition in children with IBD is scarce and inconsistent. Furthermore, most studies used anthropometric measures and dual energy X-ray absorptiometry (DEXA) for body composition assessment, while information on the usefulness of air displacement plethysmography (ADP) for this assessment is lacking. Objectives: To assess body composition in children with IBD by ADP and DEXA at diagnosis and at various intervals during follow up. Design: A prospective cohort study. Setting: Pediatric gastroenterology institute, Schneider Children's Hospital. Participants: Children 6 year to 17 years who are diagnosed with either CD or ulcerative colitis (UC). Main outcome measures: Accuracy of ADP in comparison to DEXA and percentage of fat mass and lean mass at diagnosis and during treatment. Secondary outcome measures: Correlation of body composition to skin fold, mid arm circumference measurements, BMI, inflammatory markers, gender, disease activity and physical activity.
Efficacy of CROWN in Repair and Maintenance of the Intestinal Mucosa in Patients With CD Receiving...
Crohn's DiseaseThe purpose of this study is to evaluate CROWN's efficacy in supporting the repair and maintenance of the intestinal mucosa of patients with moderately to severely active Crohn's Disease receiving anti-Tumor Necrosis Factor (TNF) therapy (infliximab, adalimumab, certolizumab)