[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Unlimited Biotechnology LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":5},"100627068","phase-1-calm-af-ai-counteracting-age-related-loss-of-muscle-with-aav-follistatin-combined-with-angiogenesis-inducing-vegf-plasmid-gene-therapy-100627068",false,"NCT07443826","CALM-AF-AI: Counteracting Age-related Loss of Muscle With AAV-Follistatin Combined With Angiogenesis-Inducing VEGF Plasmid Gene Therapy","CALM-AF-AI","Inclusion Criteria:\n\n* Voluntary written informed consent obtained prior to any study-related procedures\n* Ability to read, understand, and sign the Informed Consent Form and reliably complete required study documents\n* Willingness to undergo medical intervention, including genetic therapy, and to comply with the visit schedule and all study procedures\n* Commitment to maintain a stable medication and supplement regimen throughout the study, with no initiation of new medications, supplements, or performance-enhancing substances unless approved by the Investigator\n* Men and women aged 35-75 years\n* Body mass index (BMI) between 18.0 and 35.0 kg\u002Fm² at screening\n* Active Prospera ZEDE eResidency or Physical Residency\n* Stable comorbid conditions for at least 3 months prior to screening\n* Postmenopausal status (women)\n* Willingness to use reliable contraception for 6 months following therapy\n* Low or undetectable antibody titers to AAV9 (≤1:100 by ELISA)\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding, or intent to become pregnant; premenopausal status (unless ≥12 months amenorrhea or FSH ≥30 IU\u002FL)\n* Subjects who have a history of alcohol or drug abuse within 1 year of study entry\n* Initiation of prohibited medications, supplements, or interventions during the study period that may confound efficacy or safety assessments\n* Active malignancy or ANY history of cancer\n* Strong family history of cancer in first-degree relatives (≥2 relatives with cancer diagnosed \\\u003C60 years) OR known hereditary cancer syndrome (BRCA1\u002F2, Lynch syndrome, Li-Fraumeni, FAP, HNPCC) without genetic counseling and enhanced surveillance clearance\n* Clinically significant cardiovascular disease, including:\n* Any history of stroke, transient ischemic attack (TIA), myocardial infarction (MI), or unstable angina (regardless of time since event)\n* Diagnosed coronary artery disease (CAD) documented by coronary angiography or stress testing\n* Significant atherosclerotic disease at any location (stenosis ≥50% in carotid, femoral, or other major arteries)\n* Prior coronary revascularization (percutaneous coronary intervention \\[PCI\\] or coronary artery bypass grafting \\[CABG\\])\n* Prior valvular repair or replacement\n* History or current diagnosis of heart failure\n* Uncontrolled hypertension (SBP \\>140 mmHg or DBP \\>85 mmHg despite treatment)\n* Left ventricular ejection fraction (LVEF) \\\u003C50%, QTc ≥480 ms, or severe valvular heart disease\n* Ventricular arrhythmias requiring chronic drug treatment or implantable cardioverter-defibrillator\n* Presence of pacemaker or persistent left bundle branch block (LBBB)\n* Known diagnosed cardiomyopathy of any etiology\n* Significant left ventricular hypertrophy, defined as maximal left ventricular wall thickness ≥15 mm in any segment at end-diastole (by echocardiography or cardiac MRI)\n* Known or suspected hypercoagulable state\u002Fthrombophilia, including any of the following:\n* Any history of venous thromboembolism (DVT, PE, or thrombosis at any site), particularly if:\n* Unprovoked, or\n* Associated with only minor provoking factors (e.g., minor surgery, combined oral contraceptives, short-term immobilization)\n* Recurrent thrombotic events, including recurrent superficial venous thrombosis\n* Thrombosis at unusual sites, including but not limited to:\n* Mesenteric, portal, or splenic vein thrombosis\n* Cerebral venous sinus thrombosis\n* Hepatic vein thrombosis (Budd-Chiari syndrome)\n* Renal vein thrombosis\n* Retinal vein thrombosis\n* Superior vena cava thrombosis not related to central venous catheterization\n* Strong family history of venous or arterial thrombosis at a young age in first-degree relatives\n* History of recurrent pregnancy loss or severe obstetric complications suggestive of a hypercoagulable state\n* High-degree myopia (≥ -6.0 diopters) or pathological myopia without ophthalmologic clearance\n* Any history of retinal detachment, vitreous hemorrhage, or retinal vascular disease (diabetic retinopathy, retinal vein occlusion, age-related macular degeneration with neovascularization)\n* Use of systemic anti-VEGF therapy (e.g., bevacizumab)\n* Current use of prohibited medications or supplements (see Section 4.3)\n* Fasting plasma glucose ≥7.0 mmol\u002FL (≥126 mg\u002FdL) at screening\n* HbA1c ≥6.5% (≥48 mmol\u002Fmol) at screening\n* Current diabetes mellitus (any type)\n* History of peptic ulcer disease within 12 months\n* Known osteoporosis (DXA T-score ≤ -2.5 at the hip or spine)\n* Severe pulmonary disease, including COPD or restrictive lung disease (FVC \\\u003C49% predicted)\n* Advanced renal disease (CKD stage 3-5, eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m²) or dialysis dependence\n* Chronic liver disease or hepatic impairment:\n* Any history of cirrhosis, chronic viral hepatitis (HBV, HCV), autoimmune hepatitis, or cholestatic liver disease\n* Active hepatitis or evidence of hepatic decompensation\n* ALT or AST \\>1.5× upper limit of normal (ULN)\n* Total bilirubin \\>1.5× ULN (unless due to Gilbert's syndrome)\n* Non-alcoholic steatohepatitis (NASH) and clinically significant liver fibrosis\n* Active cholecystitis, symptomatic gallbladder disease (e.g., biliary colic), or any other clinically significant hepatobiliary abnormality\n* Neurodegenerative, neuromuscular, psychiatric, or movement disorders associated with functional or cognitive impairment (e.g., dementia, Parkinson's disease)\n* History of drug-induced myopathy or rhabdomyolysis\n* Elevated creatine kinase (CK) at screening CK \\>1.0× ULN confirmed on two separate occasions at least 48 hours apart\n* Exception: Transient CK elevation within 72 hours of strenuous exercise, intramuscular injections, or trauma is permitted if CK normalizes (≤1.0× ULN) on repeat testing before baseline visit\n* Systemic connective tissue diseases (CTDs), including:\n* Systemic lupus erythematosus (SLE), SLE overlap syndromes, or drug-induced SLE\n* Mixed connective tissue disease (MCTD)\n* Systemic sclerosis (SSc, scleroderma): diffuse, limited, or sine scleroderma\n* Inflammatory myopathies: polymyositis (PM), dermatomyositis (DM), inclusion body myositis (IBM), immune-mediated necrotizing myopathy (IMNM), or overlap myositis\n* Primary Sjögren's syndrome requiring systemic immunosuppression (corticosteroids \\>10 mg\u002Fday prednisone equivalent, DMARDs, or biologics)\n* Rheumatoid arthritis with extra-articular manifestations or requiring biologic DMARDs\n* Undifferentiated connective tissue disease (UCTD) meeting ≥2 CTD classification criteria\n* Current or recent (within 3 months) use of immunosuppressive agents, including corticosteroids, cyclosporine, tacrolimus, methotrexate, cyclophosphamide, IVIG, or rituximab\n* Acute bacterial, fungal, or viral infection, fever, or receipt of live vaccines within 30 days prior to screening\n* Infectious disease exclusions, including:\n* Active hepatitis B infection or reactivation risk (HBsAg positive, HBV DNA detectable, or isolated anti-HBc without anti-HBs)\n* Hepatitis C infection (detectable HCV RNA or treatment within 6 months)\n* HIV infection\n* Active or latent tuberculosis (positive QuantiFERON-TB Gold Plus ≥0.35 IU\u002FmL)\n* Acute herpesvirus infection, defined as\n* Active HSV-1 or HSV-2 lesions (vesicles, ulcers, crusts) on clinical examination at screening\n* CMV or EBV IgM positive\n* Increased bleeding risk, including platelet count \\\u003C100 ×10⁹\u002FL, active anticoagulation (unless washout possible), or known coagulation disorders\n* Severe physical functional limitation (CFS\\>6)\n* Prior exposure to any AAV gene therapy product (any AAV serotype)\n* Prior exposure to any investigational drug within 90 days\n* Participation in another clinical trial within 90 days\n* Known hypersensitivity to investigational product components or immunosuppressive agents (e.g., prednisone, rapamycin)\n* Life expectancy \\\u003C6 months\n* Any condition that, in the Investigator's judgment, may pose undue risk, interfere with study outcomes, or impair study participation",true,"ALL","35 Years","75 Years",{"count":21,"type":22},12,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This Phase 1\u002F2a, open-label, non-randomized study is designed to evaluate the safety and tolerability of intramuscular AAV9-Follistatin gene therapy administered either as monotherapy or in combination with a VEGF-encoding plasmid. Secondary objectives include the assessment of preliminary signals of biological and functional activity, including changes in skeletal muscle mass and performance.",[29],"Age-related Muscle Decline",[31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61],"Sarcopenia","Muscle Atrophy","Skeletal Muscle","Muscle Weakness","Muscle Strength","Aging","Frailty","Follistatin","Myostatin","Viral Vectors","Adeno-Associated Viruses","Activins","Vascular Endothelial Growth Factor A","Angiogenesis Inducing Agents","Plasmids","Intramuscular Injections","Immunosuppression","Prednisolone","Sirolimus","Safety","Dual-Energy X-Ray Absorptiometry","Physical Endurance","Quality of Life","Adults","Middle Aged","Gene Therapy","Grip strength","Rapamycin","6MWT","VO2max","1RM","RECRUITING","2026-07-10",{"date":65,"type":66},"2026-07-13","ACTUAL",{"date":68,"type":66},"2026-06-01",{"date":70,"type":22},"2028-06-30",{"name":72,"class":73},"Unlimited Biotechnology LLC","INDUSTRY",""]