[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100380788":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":58,"locations":67,"responsibleParty":108,"collaborators":110,"id":115,"slug":34,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":116,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":34,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":139,"overallStatus":70,"whyStopped":34,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Healeon Medical Inc","INDUSTRY",[8,15,22],{"label":9,"type":10,"description":11,"interventionNames":12},"tSVF + PRP Arm1","EXPERIMENTAL","Tissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) Concentrate",[13,14],"Procedure: Tissue Stromal Vascular Fraction (tSVF) Arm 1","Biological: PRP Concentrate Arm 1",{"label":16,"type":10,"description":17,"interventionNames":18},"tSVF + PRP + cSVF Arm 2","Tissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) Concentrate + Cellular Stromal Vascular Fraction (cSVF)",[19,20,21],"Procedure: Tissue Stromal Vascular Fraction (tSVF) Arm 2","Biological: PRP Concentrate Arm 2","Procedure: Cellular Stromal Vascular Fraction (cSVF) Arm 2",{"label":23,"type":10,"description":24,"interventionNames":25},"Normal Saline IV + cSVF Arm 3","Cellular Stromal Vascular Fraction (cSVF); Sterile Normal Saline Intravenous (IV) Introduction",[26,27],"Procedure: Cellular Stromal Vascular Fraction (cSVF) Arm 3","Drug: Sterile Normal Saline (IV Solution)",[29,35,40,43,46,50,53],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"PROCEDURE","Tissue Stromal Vascular Fraction (tSVF) Arm 1","Harvesting subcutaneous tSVF with sterile, disposable microcannula system",[9],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":34},"BIOLOGICAL","PRP Concentrate Arm 1","Preparation of PRP Concentrate via sterile Terumo-Harvest System",[9],{"type":30,"name":41,"description":32,"armGroupLabels":42,"otherNames":34},"Tissue Stromal Vascular Fraction (tSVF) Arm 2",[16],{"type":36,"name":44,"description":38,"armGroupLabels":45,"otherNames":34},"PRP Concentrate Arm 2",[16],{"type":30,"name":47,"description":48,"armGroupLabels":49,"otherNames":34},"Cellular Stromal Vascular Fraction (cSVF) Arm 2","Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)",[16],{"type":30,"name":51,"description":48,"armGroupLabels":52,"otherNames":34},"Cellular Stromal Vascular Fraction (cSVF) Arm 3",[23],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":34},"DRUG","Sterile Normal Saline (IV Solution)","Suspension of cSVF in 500 cc Sterile Normal Saline (IV Solution)",[23],[59,64],{"name":60,"role":61,"phone":62,"phoneExt":34,"email":63},"Donna Alderman, DO","CONTACT","1 661 295 1110","hemwallcenter@prolotherapy.com",{"name":65,"role":61,"phone":62,"phoneExt":34,"email":66},"Kathy Cirricione, BS","hemwallcenter@gmail.com",[68,85],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Hemwall Center for Orthopedic Regenerative Medicine","RECRUITING","Valencia","California","91355","United States",{"type":76,"coordinates":77},"Point",[78,79],-118.60953,34.44361,{"lat":79,"lon":78},[82],{"name":83,"role":61,"phone":84,"phoneExt":34,"email":66},"Kelly Cirricone, BS","661-295-1110",{"facility":86,"status":87,"city":88,"state":89,"zip":90,"country":74,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Regenevita LLC","NOT_YET_RECRUITING","Stevensville","Montana","59870",{"type":76,"coordinates":92},[93,94],-114.09316,46.50992,{"lat":94,"lon":93},[97,101,105],{"name":98,"role":61,"phone":99,"phoneExt":34,"email":100},"Glenn C Terry, MD","706-566-9141","corky3444@gmail.com",{"name":102,"role":61,"phone":103,"phoneExt":34,"email":104},"Heather Terry","17065669141","info@garm.com.hn",{"name":106,"role":107,"phone":34,"phoneExt":34,"email":34},"Robert W Alexander, MD","SUB_INVESTIGATOR",{"type":109,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[111,113],{"name":60,"class":112},"UNKNOWN",{"name":114,"class":112},"Robert W. Alexander, MD","100380788",false,"NCT04238143","Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis","Adipose-Derived Biocellular Regenerative Therapy in Treatment of Osteoarthritis (OA) and Associated Connective Tissue Degeneration and Pain","GARM-MSK-ALD","Inclusion Criteria:\n\n* Documented osteoarthritic inflammatory and\u002For degenerative changes in the joint or connective tissues of the knee, hip, shoulder, Achilles tendon, Sacroiliac Joint, wrist\u002Fhand, foot\u002Fankle, or Plantar Fasciitis (PR);\n* No systemic disorders which, in opinion of principal investigator, would disqualify from safely being able to undergo the determined procedures;\n* Have the ability to understand and accept all items in Informed Consent Document;\n* Have adequate perivascular and extracellular matrix donor tissues available;\n* Mature enough to tolerate determined procedures and follow up instructions and complete post-treatment tracking responsibilities\n\nExclusion Criteria:\n\n* Systemic or psychological impairment which would preclude patient tolerance and understanding nature and extent of procedures and follow up tracking;\n* Known active cancer, chemotherapy, or radiation therapy;\n* Pregnancy;\n* Active infections which would increase risk of patient to undergo treatment;\n* High dose steroid users, or recipients of corticosteroids with a six month period before treatment date;\n* Medication or Opiate addition, or in active treatment for drug rehabilitation;\n* History of documented severe traumatic brain injuries;\n* In the opinion of the principal investigator\u002Fprovider, the patient's condition or medical issues which would not allow the individual to fully accomplish or complete the study requirements","ALL","18 Years","90 Years",{"count":126,"type":127},100,"ESTIMATED","INTERVENTIONAL",[130],"NA","Use of Biocellular and cellular approaches to treatment of Osteoarthritis (OA), musculoskeletal aging processes, pain, and degenerative changes are to be studied with minimally invasive protocols, and non-pharmaceutical means to relieve OA and its associated issues. Traditional surgical interventions have not yielded convincing long-term outcomes, including total joint replacement surgeries and medical management of the supportive structures.\n\nThis study is to use a person's own stem\u002Fstromal Cells (autologous) plus HD-PRP (important healing growth factors and signal molecules) in such cases of OA for long-term minimally invasive treatments. Baseline (existing) findings are documented, and thence tracked as to progress deemed to be result of the intervention.",[133,134,135,136,137,138],"Osteoarthritis","Osteo Arthritis Knee","Osteo Arthritis Shoulders","Osteoarthritis of Multiple Joints","Osteoarthritis, Hip","Osteoarthritis - Ankle\u002FFoot",[140,141,142,143],"Arthritis","Degenerative","Joint Disease","Rheumatoid Arthritis","2024-09-30",{"date":146,"type":147},"2024-10-01","ACTUAL",{"date":149,"type":147},"2020-01-10",{"date":151,"type":127},"2027-09-30",{"name":5,"class":6},2]