[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02844751":3,"trial-entities:NCT02844751":103,"trial-summary:NCT02844751":106},{"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":25,"interventions":28,"primary_outcomes":43,"secondary_outcomes":48,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":15,"eligibility_criteria":63,"std_ages":67,"locations":70,"central_contacts":92,"overall_officials":95,"references":98,"see_also_links":99},"NCT02844751","IRCM-2016-112","Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Knee","Safety and Effectiveness of Autologous Regenerative Cell Therapy on Pain and Inflammation Associated With Osteoarthritis of the Knee","RECRUITING","2026-08","2025-10","2025-10-14","2015-07","VivaTech International, Inc.","INDUSTRY",true,"This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the knee. Follow-up will consist of a larger sample including 4,000 patients.","This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the knee. Follow-up will consist of a larger sample including 4,000 patients.\n\nPatients will be treated for Osteoarthritis (OA) of the knee due to degeneration or chronic injury. They will be treated with autologous Stromed obtained by the Adipose Ultrasonic Cell Recovery Unit (AUCRU) and Platelet Rich Plasma (PRP) processed by RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints.\n\nCohort 1 will include PRP treatments at time of initial StroMed treatment plus at 1 week, 2 weeks and 1 month.\n\nCohort 2 will include PRP treatments at time of initial StroMed treatment plus at 1 month and 2 months.\n\nPatient outcomes will be tracked with a follow up MRI at various endpoints to 6 months, laboratory tests for inflammation markers, and knee injury and osteoarthritis outcome score (KOOS) questionnaires. SF-36 forms (a quality of life measure) and numerical rating scales (NRS) will also be used to assess safety and efficacy of treatment, as well as any reduction in patient medication and\u002For delay in pending knee replacement therapy.",[19],"Osteoarthritis",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},4000,"ESTIMATED",[29,36,40],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BIOLOGICAL","[StroMed + platelet rich plasma (PRP)]","\\[Day 0\\] - Because no enzymes or drugs are added with this mechanical process, the resulting cell concentrate still contains the extra-cellular matrix. In addition, the cells have not been altered by manipulation with enzymes or culturing. This autologous, cell concentrate is of minimal risk to the patient with no artificial ingredients added. Also Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product and by direct injection to the affected joint.",[34,35],"Cohort 1","Cohort 2",{"type":30,"name":37,"description":38,"armGroupLabels":39},"[PRP] platelet rich plasma","Additional treatments with Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product and by direct injection to the affected joint. Days 7,14 and 30",[34],{"type":30,"name":37,"description":41,"armGroupLabels":42},"Additional treatments with Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product and by direct injection to the affected joint. Days 30 and 60",[35],[44],{"measure":45,"description":46,"timeFrame":47},"Change is being assessed for the KOOS survey (Knee Osteoarthritis Outcome Score)","Knee osteoarthritis outcome score","0, 2, 6 months",[49,53,57],{"measure":50,"description":51,"timeFrame":52},"Change is being assessed by MRI of afflicted joint","Looking for cartilage regrowth via MRI","0 and (6 - 12 months optional)",{"measure":54,"description":55,"timeFrame":56},"Change is being assessed for the SF36 survey (Short Form Health Survey)","Short Form health Survey","0,2,6 months",{"measure":58,"description":59,"timeFrame":56},"Change is being assessed for the NRS survey (Numerical Rating Scale for Pain)","Numerical Rating Scale for pain","ALL","18 Years","90 Years",{"inclusion":64,"exclusion":65,"raw_text":66},[],[],"Inclusion Criteria:\n\n1. Patients with indication of Osteoarthritis, grade 2 or more. Can be from degeneration or chronic injury.\n2. Patients range from 18-90 years of age.\n3. Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.\n4. Patients with adequate renal function, Creatinine ≤ 1.5 mg\u002Fdl.\n5. Patients with adequate cardiac and respiratory function.\n6. Patients with adequate blood coagulation activity, PT(INR) \\\u003C 1.5, APTT\n7. Patients must have adequate immune system function, with no known immunodeficiency disease.\n8. Greater than 6 months knee pain on the index side (left or right knee).\n\nExclusion Criteria:\n\n1. Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision\n2. Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke).\n3. Diagnosis of a transient ischemic attack in the 6 months prior to screening.\n4. Patients infected with hepatitis B, C or HIV.\n5. Patients with Body Mass Index (BMI) \\> 40kg\u002Fm2\n6. Presence of active infection.\n7. Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study.\n8. Conditions\u002Ftherapies\u002Ffactors which could confound or interfere with the evaluation of pain\u002Fmobility including, but not limited to:\n\n   1. Knee instability.\n   2. A varus\u002Fvalgus deformity of more than 10o, a deformity requiring osteotomy or complex surgery.\n   3. Gout or pseudo gout\n   4. Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than knee osteoarthritis\n   5. Corticosteroid injection at treatment site within 1 month\n   6. Consistent use of NSAIDs within 48 hours of procedure.",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":13,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":89},"Grove City","Pennsylvania","16127","United States",[77,82,86],{"name":78,"role":79,"phone":80,"email":81},"Scott M Herkes, MBA","CONTACT","855-984-8287","scott.herkes@gmail.com",{"name":83,"role":79,"phone":84,"email":85},"Michael P Hutchinson, DVM","412-503-3788","drmike@vivatechusa.com",{"name":87,"role":88},"Mark LoDico, MD","PRINCIPAL_INVESTIGATOR",{"lat":90,"lon":91},41.15784,-80.08867,[93,94],{"name":78,"role":79,"phone":80,"email":81},{"name":83,"role":79,"phone":84,"email":85},[96],{"name":87,"affiliation":97,"role":88},"Advanced Regenerative Medicine",[],[100],{"label":101,"url":102},"website for VivaTech","http:\u002F\u002Fwww.vivatechusa.com",{"nct_id":4,"conditions":104,"biomarkers":105},[19],[],{"nct_id":4,"found":15,"summary":107,"prompt_version":117},{"design":108,"status":109,"heading":110,"summary":111,"follow_up":112,"word_count":113,"commitments":114,"compensation":115,"drugs_mentioned":116},"This is an open-label study, meaning both you and your doctors will know which treatment you are receiving. It will initially involve 50 patients, with a larger follow-up sample of 4,000 patients.","completed","Autologous Regenerative Cell Therapy for Knee Osteoarthritis","This study is looking at the safety and effectiveness of a treatment for knee osteoarthritis, a condition causing pain and inflammation in the knee joint. The treatment uses your own cells, specifically StroMed (a cell concentrate from your own fat tissue) and Platelet Rich Plasma (PRP), which are injected directly into the affected knee. Researchers want to see if this treatment can reduce pain and inflammation. You might be able to join if you are between 18 and 90 years old and have osteoarthritis in your knee (grade 2 or more). Success will be measured by changes in your knee pain and function, as reported through questionnaires like the KOOS (Knee Osteoarthritis Outcome Score). The study plans to enroll 4000 patients, but the current status of recruitment is unclear.","Your progress will be tracked for up to 6 months after treatment, using MRIs, lab tests, and questionnaires.",129,"You would receive injections of StroMed and PRP into your knee. You would also have laboratory tests, periodic interviews, and follow-up MRIs for up to 6 months.","Not stated in the trial record.",[],"v2"]