[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100172989":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":32,"centralContacts":27,"locations":37,"responsibleParty":51,"collaborators":27,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":27,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":27,"studyType":67,"phases":68,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":78,"whyStopped":27,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Pluristem Ltd.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"150M PLX-PAD","EXPERIMENTAL","Single course, multiple IM injections",[13],"Biological: 150M PLX-PAD",{"label":15,"type":10,"description":11,"interventionNames":16},"300M PLX-PAD",[17],"Biological: 300M PLX-PAD",{"label":19,"type":20,"description":11,"interventionNames":21},"Placebo","PLACEBO_COMPARATOR",[22],"Biological: Placebo",[24,28,30],{"type":25,"name":9,"description":11,"armGroupLabels":26,"otherNames":27},"BIOLOGICAL",[9],null,{"type":25,"name":15,"description":11,"armGroupLabels":29,"otherNames":27},[15],{"type":25,"name":19,"description":11,"armGroupLabels":31,"otherNames":27},[19],[33],{"name":34,"affiliation":35,"role":36},"Carsten Perka, MD","Charité Universitätsmedizin Berlin, Dept. Of Orthopedic Surgery, Charitéplatz 1, 10117 Berlin, Germany","PRINCIPAL_INVESTIGATOR",[38],{"facility":39,"status":27,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":27},"Charité Universitätsmedizin Berlin","Berlin","State of Berlin","10117","Germany","DE",{"type":46,"coordinates":47},"Point",[48,49],13.41053,52.52437,{"lat":49,"lon":48},{"type":52,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100172989","phase-1-safety-and-efficacy-of-im-injections-of-plx-pad-for-the-regeneration-of-injured-gluteal-musculature-after-total-hip-arthroplasty-100172989",true,"NCT01525667","Safety and Efficacy of IM Injections of PLX-PAD for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty","A Phase I\u002FII, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Intramuscular Injections of Allogeneic PLX-PAD Cells for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty","Inclusion Criteria:\n\n1. Male or female subjects between 50 to 75 years of age\n2. Scheduled THA\n3. ASA Score ≤ 3\n4. Signed written informed consent\n\nExclusion Criteria:\n\n1. Muscle diseases\n2. Severe neurological diseases\n3. Opioid long term medication\n4. Pain chronification \\> stadium II of Gerbershagen\n5. Immunosuppression due to illness or medication\n6. Ankylosing spondylitis\n7. History of ectopic bone formation of any localisation\n8. Exclusion criteria for MRI (pace maker, defibrillator, ferromagnetic intracerebral clips)\n9. Uncontrolled hypertension (defined as diastolic blood pressure \\> 100 mmHg or systolic blood pressure \\> 200 mmHg during screening)\n10. Life-threatening ventricular arrhythmia or unstable angina - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged\n11. ST segment elevation myocardial infarction and\u002For TIA\u002FCVA within three (3) months prior to enrollment. Subjects with severe congestive heart failure symptoms (i.e. NYHA Stage IV)\n12. Subject has malignancy undergoing treatment including chemotherapy, radiotherapy or immunotherapy\n13. Body Mass Index (BMI) of 35 Kg\u002Fm2 or greater\n14. Known allergies to protein products (horse or bovine serum, or porcine trypsin) used in the cell production process\n15. Known HIV, syphilis at time of screening\n16. Known active Hepatitis B, or Hepatitis C infection at the time of screening\n17. Pregnant or breast-feeding women or women of childbearing potential not protected by an effective contraceptive method of birth control (defined as pearl index \\\u003C 1)\n18. In the opinion of the investigator, the subject is unsuitable for cellular therapy\n19. Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s)\n20. Subjects who are legally detained in an official institute",false,"ALL","50 Years","75 Years",{"count":65,"type":66},20,"ACTUAL","INTERVENTIONAL",[69,70],"PHASE1","PHASE2","Local administration of PLX-PAD single dose, intra-muscular injection for the regeneration of injured gluteal musculature after Total Hip Arthroplasty (THA).",[73,74],"Total Hip Arthroplasty","Muscle Injury",[76,77],"THA","Muscle injury","COMPLETED","2015-09-07",{"date":81,"type":82},"2015-09-21","ESTIMATED",{"date":84,"type":27},"2012-11",{"date":86,"type":66},"2015-06",{"name":5,"class":6},1]