[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100354774":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":49,"centralContacts":53,"locations":58,"responsibleParty":60,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":58,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":58,"enrollmentInfo":72,"targetDuration":58,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":97,"overallStatus":106,"whyStopped":58,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":58},{"fullName":5,"class":6},"R3 Stem Cell","INDUSTRY",[8,14,18,22,26,30,34],{"label":9,"type":10,"description":11,"interventionNames":12},"Amniotic and Umbilical Cord Tissue for Autoimmune Conditions","EXPERIMENTAL","Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for autoimmune conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.",[13],"Biological: Amniotic and Umbilical Cord Tissue Procedure",{"label":15,"type":10,"description":16,"interventionNames":17},"Amniotic and Umbilical Cord Tissue for Orthopedic Conditions","Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for orthopedic conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Amniotic and Umbilical Cord Tissue for Neurologic Conditions","Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for neurologic conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Amniotic and Umbilical Cord Tissue for Urologic Conditions","Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for urologic conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Amniotic and Umbilical Cord Tissue for Cardiac Conditions","Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for cardiac conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Amniotic and Umbilical Cord Tissue for Renal Conditions","Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for renal conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.",[13],{"label":35,"type":10,"description":36,"interventionNames":37},"Amniotic and Umbilical Cord Tissue for Pulmonary Conditions","Purpose is to evaluate an amniotic and umbilical cord stem cell rich tissue substance for pulmonary conditions. Outcomes will be compared to the literature results of the current gold standard for several conditions.",[13],[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"BIOLOGICAL","Amniotic and Umbilical Cord Tissue Procedure","Amniotic and Umbilical Cord Cell Therapy with protocols dependent on the patient condition. Protocols include options for IV, Injection, Intranasal and\u002For Nebulizer.",[9,27,19,15,35,31,23],[45,46,47,48],"Amniotic and Umbilical Cord Tissue Infusion","Amniotic and Umbilical Cord Tissue Nebulizer","Amniotic and Umbilical Cord Tissue Injection","Amniotic and Umbilical Cord Tissue Intranasal",[50],{"name":51,"affiliation":5,"role":52},"David Greene, MD, MBA","STUDY_DIRECTOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":58,"email":59},"David L Greene, MD, MBA","CONTACT","(844) 438-7836",null,"info@r3stemcell.com",{"type":61,"investigatorFullName":58,"investigatorTitle":58,"investigatorAffiliation":58,"oldNameTitle":58,"oldOrganization":58},"SPONSOR","100354774","phase-1-safety-and-clinical-outcomes-with-amniotic-and-umbilical-cord-tissue-therapy-for-numerous-medical-conditions-100354774",false,"NCT03899298","Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions","Safety and Clinical Outcomes Study: Amniotic and Umbilical Cord Tissue Administration for Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions","Inclusion Criteria:\n\n1. Age 18 and over.\n2. Ability to attend follow up visits or at least converse on phone or complete email follow up forms.\n3. Competent to understand the study protocol and provide voluntary informed consent.\n4. Patients with any of the following conditions: Arthritis (Degenerative, Rheumatoid, Psoriatic, Lupus, Gout), Sports or Overuse Injuries (e.g. Rotator Cuff injury, Tennis Elbow), Chronic Kidney Disease (may be on dialysis), Back\u002FNeck Pain, Erectile Dysfunction, Peyronie's Disease, Alzheimer's Disease, Parkinson's Disease, Neuropathy, Post-Stroke, Post-Concussion Syndrome, COPD, Emphysema, Pulmonary Fibrosis, Post myocardial infarction (at least 6 months out), Cardiomyopathy, Congestive Heart Failure.\n\nExclusion Criteria:\n\n1. Active Cancer\n2. Pregnancy, Lactating\n3. Severe Clotting disorder\n4. Myocardial Infarction less than six months ago.",true,"ALL","18 Years",{"count":73,"type":74},5000,"ESTIMATED","INTERVENTIONAL",[77],"PHASE1","To determine the safety and efficacy of Amniotic and Umbilical Cord Tissue for the treatment of the following condition categories: Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions. The hypotheses are that the treatments are not only extremely safe, but also statistically beneficial for all conditions. Outcomes will be determined by numerous valid outcome instruments that compile general quality of life information along with condition-specific information as well.",[80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96],"Orthopedic Disorder","Neurologic Disorder","Urologic Diseases","Erectile Dysfunction","Autoimmune Diseases","Renal Failure","Renal Insufficiency","Kidney Diseases","Cardiac Event","Cardiomyopathies","CHF","Pulmonary Disease","COPD","Alzheimer Disease","Stroke","Neuropathy;Peripheral","Arthritis",[98,99,100,101,102,103,104,105],"stem cell therapy","umbilical stem cells","amniotic stem cells","stem cells","regenerative medicine","r3 stem cell","perinatal tissue","placenta stem cell","NOT_YET_RECRUITING","2019-08-20",{"date":109,"type":110},"2019-08-22","ACTUAL",{"date":112,"type":74},"2019-09-01",{"date":114,"type":74},"2029-03-20",{"name":5,"class":6}]