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National GMA Post-market Clinical Follow-up Study (GRACE)

Recruitingn/aAges 18 Years - anyAllAdacyte Therapeutics SL
NCT05636709 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Inflammatory bowel disease (IBD) encompasses several chronic diseases of which ulcerative colitis (UC) and Crohn's disease (CD) are the most representative. IBD is characterised by the presence of an inflammatory process that affects different segments of the digestive tract and has a chronic and relapsing course with flares of activity. Inflammatory activity in IBD is associated with an increase in peripheral blood activated granulocytes and monocyte-macrophages and intestinal infiltration by these inflammatory cells, which are largely responsible for tissue damage. In recent years, observational, prospective studies and meta-analyses of these studies have contributed to consider granulocytapheresis (GMA) as an effective and safe alternative in the treatment of UC. This apheresis technique is based on recirculation of the patient's blood through a circuit with cellulose acetate sphere

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. ≥18 years. 2. Established diagnosis of UC or CD according to ECCO criteria. 3. Patients in whom the physician in charge of treatment decides to start treatment with GMA and independently of their inclusion in the study. 4. Patients who understand and voluntarily sign informed consent. Exclusion Criteria: 1. Patient with any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to comply with the study procedures. 2. Patient who is participating in a clinical trial. NOTE: If the physician knows or suspects that the patient is unable to understand the implications of his/her participation in the study, the patient should not enter without the signature of his/her legal representative
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What it tests

  • Adacolumn
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Where

30 sites
H. Albacete
Albacete, Spain
H. General de Alicante
Alicante, Spain
H. Germans Trias i Pujol
Badalona, Spain
H. Vall d´hebron
Barcelona, Spain
H. Galdakao
Galdakao, Spain
H. General de Castellón
Castellon, Spain
H. Puerta del Mar
Cadiz, Spain
H. Reina Sofía
Córdoba, Spain

…and 22 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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