[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03011398":3,"trial-entities:NCT03011398":358,"trial-summary:NCT03011398":370},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":32,"secondary_outcomes":37,"sex":68,"minimum_age":22,"maximum_age":22,"healthy_volunteers":15,"eligibility_criteria":69,"std_ages":75,"locations":79,"central_contacts":321,"overall_officials":322,"references":327,"see_also_links":357},"NCT03011398","RSI2015-REG01","A Clinical Registry of Orthobiologics Procedures","Interventional Orthopedics Foundation Patient Registry Database-A Clinical Registry of Orthobiologics Procedures","ENROLLING_BY_INVITATION","2036-02","2025-04","2025-04-06","2016-02","Regenexx, LLC","INDUSTRY",false,"The purpose of the Registry study is to observe the improvement in subject-reported clinical outcomes for percutaneous orthopedic procedures for treatment of musculoskeletal disorders.","This Registry was designed to assure that the benefits and knowledge gained by studying clinical outcomes associated with the use of percutaneous orthopedic procedures outweigh the potential risks to the patients. The primary objective of this Registry is to observe the improvements in subject-reported clinical outcomes for these procedures used to treat musculoskeletal disorders. Secondary objectives include evaluating post-treatment complication, adverse events, re-injections, and surgical intervention. Patients receiving percutaneous orthopedic treatments are asked to enroll before receiving treatment and complete a set of baseline questionnaires regarding pain and functionality of the area of the body being treated (i.e. knee, shoulder, spine, etc). Follow-up outcomes are collected at 1 month, 3 months, 6 months, 12 months, 18 months, and annually 2-20 years post-injection. Subjects are withdrawn from the Registry prematurely if a surgical operation occurs.",[19],"Orthopedic Disorder",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},50000,"ESTIMATED",[28],{"type":29,"name":30,"description":31},"PROCEDURE","Orthobiologic Procedures","To observe the improvement in subject-reported clinical outcomes for percutaneous orthopedic procedures used to treat musculoskeletal disorders.",[33],{"measure":34,"description":35,"timeFrame":36},"Change in Percent Improvement","Mean improvement score, where -100=100% worse from baseline and 100=100% better or improved from baseline","1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment",[38,41,44,47,50,53,56,59,62,65],{"measure":39,"description":40,"timeFrame":36},"Pain Scale","Mean numeric pain score, where 0=no pain and 10=worst possible pain.",{"measure":42,"description":43,"timeFrame":36},"International Knee Documentation Committee form","Mean IKDC score, where 0=lowest level of knee function and 100=highest level of knee function.",{"measure":45,"description":46,"timeFrame":36},"Lower Extremity Function Scale","Means LEFS score, where 0=very low function of the lower extremity and 80=very high function of the lower extremity",{"measure":48,"description":49,"timeFrame":36},"Disabilities of the Arm, Shoulder and Hand form","Mean DASH score, where 0=no disability of the upper extremity and 100=most severe disability of the upper extremity.",{"measure":51,"description":52,"timeFrame":36},"Oxford Hip Score","Mean OHS score, where 42-48=excellent, 34-41=good, 27-33=fair, 0-26=poor for hip pain and function.",{"measure":54,"description":55,"timeFrame":36},"Functional Rating Index","Mean FRI score, where 0=no disability in function of the neck and back and 100=severe disability.",{"measure":57,"description":58,"timeFrame":36},"Complications","Description of any medical complication related to receiving a treatment procedure",{"measure":60,"description":61,"timeFrame":36},"Adverse Events","Description of adverse events occurring after treatment procedure",{"measure":63,"description":64,"timeFrame":36},"Number of Re-injections to treated area","number of additional injections to treated area such as platelet rich plasma or stem cell treatment",{"measure":66,"description":67,"timeFrame":36},"Number of Surgical Interventions to treated area","Number of surgical interventions to treated area after receiving treatment procedure","ALL",{"inclusion":70,"exclusion":72,"raw_text":74},[71],"Candidates must meet ALL of the following:",[73],"none","Inclusion Criteria:\n\n* Candidates must meet ALL of the following:\n\n  1. Voluntary signature of the IRB approved Informed Consents,\n  2. Treated with a Regenexx procedure\n  3. Have a musculoskeletal condition appropriate for the procedure such as osteoarthritis or internal joint derangement; ligament or tendon injury; intervertebral disc degeneration; protrusion, extrusion, or annular tear; muscle tear\n\nExclusion Criteria:\n\n* none",[76,77,78],"CHILD","ADULT","OLDER_ADULT",[80,89,97,103,109,116,123,131,135,143,151,158,166,174,182,190,198,206,213,220,227,235,242,250,258,266,273,280,288,296,304,313],{"facility":81,"city":82,"state":83,"zip":84,"country":85,"geoPoint":86},"Catalyst Pain Solutions","Phoenix","Arizona","85008","United States",{"lat":87,"lon":88},33.44838,-112.07404,{"facility":90,"city":91,"state":92,"zip":93,"country":85,"geoPoint":94},"Healthlink Center","Beverly Hills","California","90035",{"lat":95,"lon":96},34.07362,-118.40036,{"facility":90,"city":98,"state":92,"zip":99,"country":85,"geoPoint":100},"Oceanside","92056",{"lat":101,"lon":102},33.19587,-117.37948,{"facility":90,"city":104,"state":92,"zip":105,"country":85,"geoPoint":106},"San Rafael","94903",{"lat":107,"lon":108},37.97353,-122.53109,{"facility":110,"city":111,"state":92,"zip":112,"country":85,"geoPoint":113},"Southern California Orthopedic Institute","Thousand Oaks","91361",{"lat":114,"lon":115},34.17056,-118.83759,{"facility":117,"city":118,"state":92,"zip":119,"country":85,"geoPoint":120},"Southern California Orthopedic Institute-Van Nuys","Van Nuys","91405",{"lat":121,"lon":122},34.18667,-118.44897,{"facility":124,"city":125,"state":126,"zip":127,"country":85,"geoPoint":128},"Centeno-Schultz Clinic","Broomfield","Colorado","80021",{"lat":129,"lon":130},39.92054,-105.08665,{"facility":132,"city":125,"state":126,"zip":133,"country":85,"geoPoint":134},"Regenexx","80026",{"lat":129,"lon":130},{"facility":136,"city":137,"state":138,"zip":139,"country":85,"geoPoint":140},"New reGeneration Orthopedics","Sarasota","Florida","34243",{"lat":141,"lon":142},27.33643,-82.53065,{"facility":144,"city":145,"state":146,"zip":147,"country":85,"geoPoint":148},"Chicago Arthritis","Chicago","Illinois","60657",{"lat":149,"lon":150},41.85003,-87.65005,{"facility":152,"city":153,"state":146,"zip":154,"country":85,"geoPoint":155},"Orthopedic Stem Cell Resource","Des Plaines","60016",{"lat":156,"lon":157},42.03336,-87.8834,{"facility":159,"city":160,"state":161,"zip":162,"country":85,"geoPoint":163},"Harbor View Medical","Des Moines","Iowa","50321",{"lat":164,"lon":165},41.60054,-93.60911,{"facility":167,"city":168,"state":169,"zip":170,"country":85,"geoPoint":171},"Bodyworks Musculoskeletal Medicine","Louisville","Kentucky","40223",{"lat":172,"lon":173},38.25424,-85.75941,{"facility":175,"city":176,"state":177,"zip":178,"country":85,"geoPoint":179},"Total Care-LA","Lafayette","Louisiana","70503",{"lat":180,"lon":181},30.22409,-92.01984,{"facility":183,"city":184,"state":185,"zip":186,"country":85,"geoPoint":187},"Stem Cell ARTS-MD","Chevy Chase","Maryland","20815",{"lat":188,"lon":189},39.00287,-77.07115,{"facility":191,"city":192,"state":193,"zip":194,"country":85,"geoPoint":195},"RejuvMedical","Waite Park","Minnesota","56387",{"lat":196,"lon":197},45.55719,-94.22416,{"facility":199,"city":200,"state":201,"zip":202,"country":85,"geoPoint":203},"New Jersey Sports Medicine","Cedar Knolls","New Jersey","07927",{"lat":204,"lon":205},40.82204,-74.44876,{"facility":207,"city":208,"state":201,"zip":209,"country":85,"geoPoint":210},"Orthopedic Stem Cell Solutions","Oakhurst","07755",{"lat":211,"lon":212},40.27094,-74.01625,{"facility":214,"city":215,"state":201,"zip":216,"country":85,"geoPoint":217},"Rehabilitation Center of New Jersey","Wayne","07470",{"lat":218,"lon":219},40.92538,-74.27654,{"facility":221,"city":222,"state":222,"zip":223,"country":85,"geoPoint":224},"Rehabilitation Center of New York","New York","10001",{"lat":225,"lon":226},40.71427,-74.00597,{"facility":228,"city":229,"state":230,"zip":231,"country":85,"geoPoint":232},"Beacon Orthopaedics","Cincinnati","Ohio","45241",{"lat":233,"lon":234},39.12711,-84.51439,{"facility":236,"city":237,"state":230,"zip":238,"country":85,"geoPoint":239},"ProMedica","Toledo","43612",{"lat":240,"lon":241},41.66394,-83.55521,{"facility":243,"city":244,"state":245,"zip":246,"country":85,"geoPoint":247},"RegenOrthoSport","Tulsa","Oklahoma","74136",{"lat":248,"lon":249},36.15398,-95.99277,{"facility":251,"city":252,"state":253,"zip":254,"country":85,"geoPoint":255},"Columbia Pain Management","Hood River","Oregon","97031",{"lat":256,"lon":257},45.7054,-121.52146,{"facility":259,"city":260,"state":261,"zip":262,"country":85,"geoPoint":263},"Rehabilitation and Pain Specialists","Pittsburgh","Pennsylvania","15238",{"lat":264,"lon":265},40.44062,-79.99589,{"facility":267,"city":268,"state":261,"zip":269,"country":85,"geoPoint":270},"Center for Sports Medicine","Springfield","19064",{"lat":271,"lon":272},39.93067,-75.32019,{"facility":243,"city":274,"state":275,"zip":276,"country":85,"geoPoint":277},"Dallas","Texas","75230",{"lat":278,"lon":279},32.78306,-96.80667,{"facility":281,"city":282,"state":283,"zip":284,"country":85,"geoPoint":285},"Wasatch Pain Solutions","South Jordan","Utah","84095",{"lat":286,"lon":287},40.56217,-111.92966,{"facility":289,"city":290,"state":291,"zip":292,"country":85,"geoPoint":293},"Vermont Regenerative Medicine","Winooski","Vermont","05404",{"lat":294,"lon":295},44.49144,-73.18568,{"facility":297,"city":298,"state":299,"zip":300,"country":85,"geoPoint":301},"Stem Cell ARTS-VA","McLean","Virginia","22102",{"lat":302,"lon":303},38.93428,-77.17748,{"facility":305,"city":306,"state":307,"zip":308,"country":309,"geoPoint":310},"Nepean Specialist Sports Medicine","Kingswood","New South Wales","2747","Australia",{"lat":311,"lon":312},-33.75614,150.72346,{"facility":243,"city":314,"state":315,"zip":316,"country":317,"geoPoint":318},"Hyderabad","Telangana","500001","India",{"lat":319,"lon":320},17.38405,78.45636,[],[323],{"name":324,"affiliation":325,"role":326},"Christopher Centeno, MD","Regenerative Sciences, LLC and Centeno-Schultz Clinic","PRINCIPAL_INVESTIGATOR",[328,332,335,338,341,344,348,351,354],{"pmid":329,"type":330,"citation":331},"19951252","BACKGROUND","Centeno CJ, Schultz JR, Cheever M, Robinson B, Freeman M, Marasco W. Safety and complications reporting on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther. 2010 Mar;5(1):81-93. doi: 10.2174\u002F157488810790442796.",{"pmid":333,"type":330,"citation":334},"22023622","Centeno CJ, Schultz JR, Cheever M, Freeman M, Faulkner S, Robinson B, Hanson R. Safety and complications reporting update on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther. 2011 Dec;6(4):368-78. doi: 10.2174\u002F157488811797904371.",{"pmid":336,"type":330,"citation":337},"16956842","Bain BJ. Morbidity associated with bone marrow aspiration and trephine biopsy - a review of UK data for 2004. Haematologica. 2006 Sep;91(9):1293-4.",{"pmid":339,"type":330,"citation":340},"20392971","Nejadnik H, Hui JH, Feng Choong EP, Tai BC, Lee EH. Autologous bone marrow-derived mesenchymal stem cells versus autologous chondrocyte implantation: an observational cohort study. Am J Sports Med. 2010 Jun;38(6):1110-6. doi: 10.1177\u002F0363546509359067. Epub 2010 Apr 14.",{"pmid":342,"type":330,"citation":343},"20603892","Wakitani S, Okabe T, Horibe S, Mitsuoka T, Saito M, Koyama T, Nawata M, Tensho K, Kato H, Uematsu K, Kuroda R, Kurosaka M, Yoshiya S, Hattori K, Ohgushi H. Safety of autologous bone marrow-derived mesenchymal stem cell transplantation for cartilage repair in 41 patients with 45 joints followed for up to 11 years and 5 months. J Tissue Eng Regen Med. 2011 Feb;5(2):146-50. doi: 10.1002\u002Fterm.299.",{"pmid":345,"type":346,"citation":347},"35932306","DERIVED","Centeno CJ, Berger DR, Money BT, Dodson E, Urbanek CW, Steinmetz NJ. Percutaneous autologous bone marrow concentrate for knee osteoarthritis: patient-reported outcomes and progenitor cell content. Int Orthop. 2022 Oct;46(10):2219-2228. doi: 10.1007\u002Fs00264-022-05524-9. Epub 2022 Aug 6.",{"pmid":349,"type":346,"citation":350},"35844014","Centeno CJ, Money BT, Dodson E, Stemper I, Steinmetz NJ. The rate of venous thromboembolism after knee bone marrow concentrate procedures: should we anticoagulate? Int Orthop. 2022 Oct;46(10):2213-2218. doi: 10.1007\u002Fs00264-022-05500-3. Epub 2022 Jul 18.",{"pmid":352,"type":346,"citation":353},"30176875","Centeno C, Markle J, Dodson E, Stemper I, Williams C, Hyzy M, Ichim T, Freeman M. Symptomatic anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow concentrate and platelet products: a non-controlled registry study. J Transl Med. 2018 Sep 3;16(1):246. doi: 10.1186\u002Fs12967-018-1623-3.",{"pmid":355,"type":346,"citation":356},"28938891","Centeno C, Markle J, Dodson E, Stemper I, Williams CJ, Hyzy M, Ichim T, Freeman M. Treatment of lumbar degenerative disc disease-associated radicular pain with culture-expanded autologous mesenchymal stem cells: a pilot study on safety and efficacy. J Transl Med. 2017 Sep 22;15(1):197. doi: 10.1186\u002Fs12967-017-1300-y.",[],{"nct_id":4,"conditions":359,"biomarkers":369},[360,361,362,363,364,365,366,367,368],"Annular Tear","Derangement of knee","Displacement of intervertebral disc","Injury of tendon","Intervertebral Disc Degenerative Disorder","Ligament Injury","Musculoskeletal Disorder","Osteoarthritis","Rupture of muscle",[],{"nct_id":4,"found":15,"summary":22,"prompt_version":22}]