[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615310":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":26,"responsibleParty":41,"collaborators":26,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":26,"enrollmentInfo":54,"targetDuration":26,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":71,"whyStopped":26,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":26},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mesenchymal Stem Cells","EXPERIMENTAL","Treatment with intraglandular injections in both submandibular glands with allogeneic adipose derived mesenchymal stem cells",[13],"Drug: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Treatment with intraglandular injections in both submandibular glands sterile isotonic saline water",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS","Suspended in 10% DMSO. Manufactured by OUH CELL BENCH in Odense, Denmark.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Sterile isotonic saline water",[15],[31],{"name":32,"affiliation":33,"role":34},"Christian von Buchwald, MD, Professor","Copenhagen University Hospital - Rigshospital","STUDY_CHAIR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Joachim Hansen, M.D","CONTACT","+4523312552","joachim.hansen.01@regionh.dk",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Christian von Buchwald","MD, DMSc, professor","100615310","phase-2-repeated-mesenchymal-stem-cell-therapy-for-radiation-induced-hyposalivation-and-xerostomia-in-head-and-neck-cancer-survivors-100615310",false,"NCT07290946","Repeated Mesenchymal Stem Cell Therapy for Radiation-Induced Hyposalivation and Xerostomia in Head and Neck Cancer Survivors","MESRIX-more","Inclusion Criteria:\n\n1. Former radiotherapy for squamous cell carcinoma, or adenocarcinoma, of the nasal sinus, larynx, pharynx, and oral cavity\n2. WHO Performance status 0-1\n3. Presence of xerostomia daily\n4. UWS of 0.05 mL\u002Fmin to 0.5 ml\u002Fmin\n5. Age above 18\n6. Informed consent\n7. 0.5 year follow-up of the cancers in 1. with no recurrence\n\nExclusion Criteria:\n\n1. Any malignant cancer diagnosis excluding head and neck cancers\n2. Xerogenic medications at inclusion\n3. Penicillin or streptomycin allergy assessed by health personnel\n4. Any other previous or active disease of the salivary glands (e.g. Sjögren's Disease, sialolothiasis)\n5. Previous submandibular surgery or biopsy\n6. Pregnancy or planned pregnancy until 4 months after second treatment\n7. Breastfeeding\n8. Smoking within the last 6 months\n9. Alcohol abuse within the last 6 months (consumption must not be above 10 units\u002Fweek (Danish National board health alcohol guidelines)","ALL","18 Years",{"count":55,"type":56},100,"ESTIMATED","INTERVENTIONAL",[59],"PHASE2","Dry mouth leads to debilitating symptoms 24\u002F7. The two primary causes for dry mouth are Sjögrens disease and after radiotherapy of a head and neck cancer. Former clinical trials have investigated mesenchymal stem cell treatment for dry mouth with promising results. However, few of the participants evolved normal salivary flow rate. Therefore, in this randomized clinical trial, two treatments of mesenchymal stem cells are administered, 4 months apart. This has not been done before.\n\nThe hypothesis is that two treatments of mesenchymal stem cells results in a higher salivary flow rate and ameliorate symptoms from dry mouth.",[62,63,64],"Xerostomia Due to Hyposecretion of Salivary Gland","Xerostomia Due to Radiotherapy","Sjögren´s Syndrome",[66,67,68,69,70],"Mesenchymal Stem Cell","Sjögren","Radiation","xerostomia","Head and Neck cancer","NOT_YET_RECRUITING","2025-12-04",{"date":74,"type":75},"2025-12-18","ACTUAL",{"date":77,"type":56},"2025-12",{"date":79,"type":56},"2028-12",{"name":43,"class":6}]