[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"systemic-sclerosis-pulmonary\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:systemic-sclerosis-pulmonary":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100572392","home-based-clinical-management-of-interstitial-lung-disease-in-systemic-rheumatic-diseases-100572392",false,"NCT06732674","Home Based Clinical Management of Interstitial Lung Disease in Systemic Rheumatic Diseases","A 54-week, Multi-centre, 2-arm, Randomised Controlled Trial to Assess Home Monitoring for Lung Function and Patient Reported Outcome Measurements Vs. Usual Care in RheuMatic Disease-associated Interstitial Lung Disease: the RMD-mILDer Trial","RMD-mILDer","Inclusion Criteria:\n\n* Systemic rheumatic disease (Systemic sclerosis (SSc), rheumatoid arthritis (RA), idiopathic inflammatory myopathies including antisynthetasis syndromes (IIM), mixed connective tissue disease (MCTD) or Sjøgrens disease (SjD)) classifiable by disease-specific classification criteria\n* Diagnosed interstitial lung disease (ILD) on high resolution computed tomography (HRCT) ≥ 1 year prior to randomization, not explained by other diseases or exposures\n* On stable standard of care treatment 6 months prior to randomization\n* Participants must be able to understand and follow trial procedures including completion of questionnaires regarding Patient Reported Outcome measures\n* Participants must have access to the internet, and experience in using smartphones or other electronic devices with internet access\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Severe heart failure with ejection fraction (EF) \\\u003C 30%\n* Chronic renal failure G4 or more (defined by KDIGO) with glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin using Cockroft-Gault formula.\n* End stage lung disease with forced vital capacity (FVC) \\\u003C 50% and\u002For diffusion capacity for carbon monoxide (DLCO) \\\u003C 40% or coexisting severe other lung diseases (e.g. chronic obstructive pulmonary disease, emphysema)\n* Airway obstruction (pre-bronchodilator FEV1\u002FFVC \\\u003C 0.7) (FEV1 is defined as forced expiratory volume in 1 sec)\n* In the opinion of the investigator, other clinically significant pulmonary abnormalities\n* Significant pulmonary hypertension defined by the following: Previous clinical or echocardiographic evidence of significant right heart failure OR history of right heart catheterization showing a cardiac index \\\u003C\u002F= 2 L\u002Fmin\u002Fm2 OR pulmonary hypertension requiring therapy with epoprostenol\u002Ftreprostinil\n* Active treatment for cancer or non-curable cancer\n* Relative contraindications to performing spirometry, as specified in ATS\u002FERS guidelines.\n* Ongoing Prednisolone ≥ 20 mg\u002Fday at inclusion\n* Unable to speak, write and read Norwegian, German or Romanian in the respective country of inclusion.\n* Unable to perform good quality measurements of FVC on the home-device comparable to results on an in-hospital device, after training.\n* Pregnancy or planned pregnancy","ALL","18 Years",{"count":20,"type":21},218,"ESTIMATED","INTERVENTIONAL",[24],"NA","The RMD-mILDer trial is a home monitoring strategy trial aiming to improve management of interstitial lung disease related to rheumatic diseases applying eHealth technology.\n\nIt is planned as a 2 arm 54 week multi-centre randomised controlled trial to assess outcome of home monitoring with bi-weekly serial forced vital capacity- and patient reported outcome-measurements compared to standard of care with fixed-interval hospital visits in adult patients with rheumatic disease associated interstitial lung diseases.",[27,28,29,30,31,32],"Interstitial Lung Disease with Progressive Fibrotic Phenotype in Diseases Classified Elsewhere","Systemic Sclerosis Pulmonary","Dermatomyositis","Rheumatoid Arthritis","Sjogren Syndrome with Lung Involvement","Connective Tissue Diseases",[34,35,36,37,38,39,29,40],"home monitoring","remote monitoring","interstitial lung disease","rheumatic disease","lung fibrosis","Systemic sclerosis","Sjøgren","RECRUITING","2024-12-16",{"date":44,"type":45},"2024-12-19","ACTUAL",{"date":42,"type":21},{"date":48,"type":21},"2028-02-28",{"name":50,"class":51},"Oslo University Hospital","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":60,"enrollmentInfo":4,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":75,"locationsCount":52},"100395703","infusion-of-allogeneic-mesenchymal-stem-cells-in-patients-with-diffuse-cutaneous-systemic-sclerosis-with-refractory-pulmonary-involvement-100395703","NCT04432545","Infusion of Allogeneic Mesenchymal Stem Cells in Patients With Diffuse Cutaneous Systemic Sclerosis With Refractory Pulmonary Involvement","Infusion of Allogeneic Stromal Mesenchymal Stem Cells From Wharton´s Jelly in Patients With Diffuse Cutaneous Systemic Sclerosis With Refractory Pulmonary Involvement to Treatment","Inclusion Criteria:\n\n* Age\\> 18 years and \\\u003C65 years.• Established diagnosis of systemic sclerosis according to the criteria of theAmerican College of Rheumatology• SSc of poor prognosis, involving life-threatening severe visceralinvolvement (cardiac or pulmonary hypertension ), lack of response toconventional immunosuppressive therapy used in severe forms of thedisease according to the European recommendations of EUSTAR and EBMT, relying on high doses of IV cyclophosphamide (either in monthlybolus for at least six months); or SSc with life-threatening pulmonaryhypertension. Patients may or may not have pulmonary fibrosis.• Signed informed consent.• Presence of a consenting MSC donor• Affiliation to social security\n\nExclusion Criteria:\n\n* Pregnancy or absence of appropriate contraception throughout the study.• Pulmonary artery systolic pressure (PASP) \\>75mmHg (onechocardiography or after right heart catheterization);- Theorical DLCO \\\u003C30%• Calculated creatinine clearance \\\u003C30 ml\u002Fmn\u002Fm2• Clinical sign of a congestive heart failure refractory ;• Left ventricular ejection fraction \\\u003C35% at myocardial scintigraphy orechocardiography;• Chronic atrial fibrillation requiring oral anticoagulant therapy;• Uncontrolled ventricular arrhythmia;• Pericardial effusion with hemodynamic compromise assessed byechocardiography.• Hepatic impairment defined as a persistent increase in transaminases orbilirubin to 3 times normal.• Psychiatric disorders, including drug taking and alcohol abuse.• Active neoplasia or concomitant myelodysplasia, antecedent of neoplasia.• Bone marrow failure defined by neutropenia \\\u003C0.5 x 109 \u002F L,thrombocytopenia \\\u003C50 x 109 \u002F L, anemia \\\u003C8 g \u002F dL, CD4 lymphopenia \\\u003C200x 106 \u002F L.• Uncontrolled systemic hypertension.• Uncontrolled acute or chronic infection, HIV1, 2 or HTLV-1, 2seropositivity.• Chronic hepatitis B or C active.• Significant exposure to bleomycin, toxic oils, vinyl chloride,trichloroethylene or silica; eosinophilia-myalgia syndrome, eosinophiliafasciitis.• Risk of poor patient compliance","65 Years","EXPANDED_ACCESS","Progressive SSc is an entity with limited therapeutic alternatives and with asurvival rate of less than 45% in the first 3 to 5 years. The disease causessevere limitation in quality of life ranging from functional limitation to depression. Up to 20% of patients will be refractory to conventional treatment with diseasemodifying anti-rheumatic drugs (DMARDs) and cyclophosphamide therapy.This favors the progression to visceral involvement including gastrointestinal,lung and pulmonary hypertension. The latter being a poor prognostic factor,increases mortality in this group of patients and drastically affects their qualityof life. For this reason, different therapeutic options have been considered including cell transplantation and Stem Cell use. Among the options that have been studied so far are stromal mesenchymal cells from Wharton ́s jelly. These have been used in intravenous infusion or direct application in different disease scenarios ranging from vascular involvement to interstitial lung involvement and cases of pulmonary hypertension, with promising results in terms of clinical progression,improvement in quality of life and prognostic indices. This therapy has proven to have a significant margin of safety at the time of administration and a low rate of adverse events, a self-limiting fever as the most frequent event. Based on the above and considering the possibility of offering patients without therapeutic alternatives to their disease in addition to palliative options, an intravenous infusion of stromal mesenchymal stem cells from Wharton ́s jellyis proposed for three patients with progressive SSc refractory to conventional therapy with pulmonary involvement due to pulmonary hypertension.\n\nUnder this premise the question posed in our work is; What are the effects of the infusion of allogeneic mesenchymal stromal cells from Wharton ́s jellyin patients with systemic sclerosis refractory to conventional treatment with Methotrexate or Cyclophosphamide in a population of three patients with severe pulmonary involvement due to pulmonary hypertension.",[28,64,65],"Pulmonary Hypertension","Pulmonary Fibrosis",[67,68,69,70],"Refractory systemic sclerosis","systemic sclerosis","pulmonary hypertension","mesenchymal stem cells","AVAILABLE","2024-04-04",{"date":74,"type":45},"2024-04-08",{"name":76,"class":51},"Universidad de la Sabana"]