[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505131":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":27,"locations":21,"responsibleParty":37,"collaborators":21,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":41,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":21,"studyType":53,"phases":54,"briefSummary":57,"conditions":58,"keywords":21,"overallStatus":60,"whyStopped":21,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":21},{"fullName":5,"class":6},"Assistance Publique Hopitaux De Marseille","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Adult patients suffering from xerostomia and autoimmune disease","EXPERIMENTAL","Xerostomia treatment consist of 3 steps (including 2 surgical steps) in the Hospital de la Conception of Marseille, in the same ward :\n\n* The plastic\u002Fmaxillofacial surgeon : collects the adipose tissue, and transfers it to the cell therapy unit;\n* The cell therapy unit processes and controls the experimental product (adipose-derived stromal vascular fraction; AD-SVF) from the harvested adipose tissue. The AD-SVF batch is nominatively transported to the surgeon;\n* The maxillofacial surgeon injects the AD-SVF without delay under local anesthesia.",[13,14],"Procedure: lipoaspiration","Drug: Injection of the autologous adipose-derived stromal vascular fraction (AD-SVF)",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"PROCEDURE","lipoaspiration","Adipose tissue harvest will be conducted by a surgeon under under local and intra-veinous sedation anesthesia. Once the patient is asleep and just before the laying of the operating drapes, the skin will be thoroughly disinfected, in order to avoid bacteriological contamination. Each entry point will be disinfected with betadine before and regularly during the procedure and will receive local anesthesia.\n\nThe lipoaspiration sites will be infiltrated using a closed system, thanks to a Khoury canula. Adipose tissue will be harvested after waiting at least 5 minutes, in order to limit hematoma and excessive blood harvesting. A 3mm incision will be made then the tissue collection will be performed using a canula, manually, by gentle aspirations into a syringe then directly transferred into a connected sterile bag.\n\nThe incision will be closed with 1 stitch of 6-0 absorbable and a paraffin gauze dressing. Then, patient will be awaken and transported to the recovery room.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"DRUG","Injection of the autologous adipose-derived stromal vascular fraction (AD-SVF)","Autologous uncultured (AD-SVF) will be isolated by digestion and centrifugation of adipose tissue from lipoaspiration.\n\nThen, AD-SVF will be injected in 6 sites :\n\n* 2 for the accessory labial glands (0.5mL in the upper lip and 0.5mL in the lower lip)\n* 2 for the sublingual glands (0.5mL for each gland)\n* 2 for the inner face of cheeks (0.5mL for each side)\n\nThe volume of injection will be of 3 mL containing 30 millions of AD-SVF viable nucleated cells for the total safety dose.",[9],[28,33],{"name":29,"role":30,"phone":31,"phoneExt":21,"email":32},"Laurent Guyot, Pr","CONTACT","04 91 43 63 13","Laurent.guyot@ap-hm.fr",{"name":34,"role":30,"phone":35,"phoneExt":21,"email":36},"Alexandra Giuliani","0491382870","alexandra.giuliani@ap-hm.fr",{"type":38,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100505131","phase-1-safety-and-potential-effect-of-innovative-cell-based-therapy-using-adipose-derived-stromal-vascular-fraction-in-patients-with-autoimmune-xerostomia-100505131",false,"NCT05857358","Safety and Potential Effect of Innovative Cell-based Therapy Using Adipose-derived Stromal Vascular Fraction in Patients With Autoimmune Xerostomia","Safety and Potential Effect of Innovative Cell-based Therapy Using Adipose-derived Stromal Vascular Fraction in Patients With Autoimmune Xerostomia (XEROCELL)","XEROCELL","Inclusion Criteria:\n\n* Patients from 18 to 65 years.\n* Patients suffering from xerostomia and autoimmune disease including : Gougerot-Sjögren disease according to AC\u002FEULAR criteria and Secondary Gougerot-Sjögren syndrome related to systemic diseases (sclerodermia, rheumatoid arthritis, systemic lupus erythematosus...)\n* Xerostomia visual scale (6-item visual analogue scale questionnaire) for assessment of salivary dysfunction : score ≥ 30\u002F60\n* Informed consent to participate (with signature)\n* Negative β -HCG test and effective contraception for women being able to get pregnant\n* Affiliation to the social security system\n\nExclusion Criteria:\n\n* Medical history of head and neck neoplasia\n* Recent (\\\u003C3 months) medication inducing and aggravating xerostomia : Standard treatment with tricyclic antidepressant and\u002For antipsychotics\n* Body Mass Index \\\u003C 18\n* Active smoking (\\> 5 cigarettes a day)\n* Active infectious disease and\u002For active viral serologies (HIV, HCV, HBV, HTLV I\u002FII, TPHA\u002FVDRL)\n* Coagulation disorders including anticoagulant and antiplatelet treatment\n* Any temporary or definitive contraindication due to any medical or surgical unstable condition\n* Allergy to local anesthesia and\u002For albumin\n* Pregnant or breastfeeding women\n* Adult protected by the law (tutorship and curatorship)\n* Patients already enrolled in another study\n* Patients under 18 years of age\n* Person deprived of liberty\n* Patient non-affiliated to the social security","ALL","18 Years","65 Years",{"count":51,"type":52},18,"ESTIMATED","INTERVENTIONAL",[55,56],"PHASE1","PHASE2","The main objective of this study is to evaluate the tolerance and safety of autologous adipose-derived stromal vascular fraction injected in accessory salivary glands for treatment of autoimmune xerostomia in terms of adverse reactions through day 14 (D14).",[59],"Xerostomia","NOT_YET_RECRUITING","2023-11-16",{"date":63,"type":64},"2023-11-18","ACTUAL",{"date":66,"type":52},"2024-01",{"date":68,"type":52},"2027-08",{"name":5,"class":6}]