[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cellcolabs Clinical LTD.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100522840","phase-1-a-study-to-evaluate-mesenchymal-stem-cell-product-stromafortes-effect-on-cardiovascular-events-100522840",false,"NCT06087848","A Study to Evaluate Mesenchymal Stem Cell Product StromaForte's Effect on Cardiovascular Events","A Longitudinal Open-Label Multi-center Single-Arm Phase I\u002FIIa Study to Evaluate the Safety and Preventive Effect on Cardiovascular Events of Human Allogenic Bone-Marrow-Derived Mesenchymal Stromal Cell Product, StromaForte, in Study Participants.","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent and comply with all procedures required by the protocol.\n2. Aged ≥ 25 to 85 years at the time of signing the informed consent form.\n3. Subjects with pre-morbid or stable morbid medical conditions, not requiring significant changes to their current medical therapy for \\> 6 months prior to enrolling in this study, are eligible\n\nExclusion Criteria:\n\n1. Unwilling or unable to perform any of the assessments required by the protocol.\n2. Have end stage liver or renal disease.\n3. Have a clinical history of malignancy within 2.5 years (i.e., study participants with prior malignancy must be cancer free for 2.5 years) except curatively treated basal cell carcinoma, melanoma in situ, or cervical carcinoma.\n4. Have any condition that limits lifespan to \\\u003C 1 year according to the Principal Investigator's discretion.\n5. Hepatitis B virus positive\n6. Viraemic Hepatitis C virus, HIV-1\u002F2 or syphilis positive\n7. Have unstable angina pectoris, uncontrolled or severe peripheral artery disease within the previous 2 months.\n8. Have congestive heart failure defined by New York Heart Association (NYHA) Class IV, or an ejection fraction of \\\u003C25%.\n9. Uncontrolled hypertension (resting systolic blood pressure \\>220 mm Hg or diastolic blood pressure of \\> 150 mm Hg at screening)\n10. Have coronary artery bypass surgery, angioplasty, peripheral vascular disease revascularization, or a myocardial infarction within the previous month.\n11. Have acute exacerbation of chronic obstructive lung disease stage III or IV (Gold classification), Have cognitive or language barriers that prohibit obtaining informed consent or any study elements.\n12. Severe acute infection at time of screening and treatment with study drug\n13. Pregnant or Breastfeeding\n14. Currently participating (or participated within the previous 30 days of consent) in an investigational therapeutic or device trial.\n15. Have a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the study participant's participation for the full duration of the study.",true,"ALL","25 Years","85 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The goal of this phase I\u002FII clinical trial is to evaluate the safety and preventive effect of intravenous infusion of human allogeneic bone-marrow-derived mesenchymal stromal cell product StromaForte in study participants. The main questions it aims to answer are:\n\nTo assess the safety and tolerability after 28 days of injection by reporting the number of adverse events assessed by Common Terminology Criteria For Adverse Events (CTCAE) To evaluate the effects of Mesenchymal stem cells on Prevention of Cardiovascular Events by following the reported incidence of cardiovascular events amongst study participants up to five year post-injection Participants will receive 100 x 106 allogeneic bone marrow (BM)-derived Mesenchymal Stromal Cell (MSC) formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion 100 million cells in approximately 30 min",[29],"Cardiovascular Diseases","RECRUITING","2024-04-17",{"date":33,"type":34},"2024-04-19","ACTUAL",{"date":36,"type":34},"2023-10-07",{"date":38,"type":22},"2029-10-06",{"name":40,"class":41},"Cellcolabs Clinical LTD.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":42},"100521837","phase-1-a-study-of-human-allogeneic-bone-marrow-derived-mesenchymal-stromal-cell-product-stromaforte-in-patients-with-musculoskeletal-injuries-andor-degeneration-100521837","NCT06074783","A Study of Human Allogeneic Bone-marrow Derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Musculoskeletal Injuries and\u002For Degeneration","A Patient Sponsored Ongoing Open-label Single-arm, Safety and Efficacy, Phase I\u002FIIb Study of Cellcolabs´ Human Allogeneic Bone-marrow Derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Musculoskeletal Injuries and\u002For Degeneration","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent and comply with all procedures required by the protocol.\n2. Aged ≥ 18 years at the time of signing the informed consent form and has any diagnosed musculoskeletal injury and\u002For degenerative conditions.\n\nExclusion Criteria:\n\n1. Unwilling or unable to perform any of the assessments required by the protocol.\n2. Have an injury that is expected to selfheal within 14 days without remaining sequel.\n3. Have an injury for which there is solid scientific evidence that the study compound will have no effect.\n4. Have traumatic head injury or skull, teeth or jaw injury as diagnosis for inclusion in trial.\n5. Have an injury that require an orthopaedic surgery that has not been addressed by local\u002Fhome surgeon.\n6. Have end stage liver or renal disease.\n7. Have a clinical history of malignancy within 2.5 years (i.e., patients with prior malignancy must be cancer free for 2.5 years) except curatively treated basal cell carcinoma, melanoma in situ, or cervical carcinoma.\n8. Have any condition that limits lifespan to \\\u003C 1 year according to the Principal Investigator's discretion.\n9. Hepatitis B virus positive\n10. Viraemic Hepatitis C virus, HIV-1\u002F2 or syphilis positive\n11. Have unstable angina pectoris, uncontrolled or severe peripheral artery disease within the previous 2 months.\n12. Have congestive heart failure defined by New York Heart Association (NYHA) Class IV, or an ejection fraction of \\\u003C25%.\n13. Uncontrolled hypertension (resting systolic blood pressure \\>220 mm Hg or diastolic blood pressure of \\> 150 mm Hg at screening) .\n14. Have coronary artery bypass surgery, angioplasty, peripheral vascular disease revascularization, or a myocardial infarction within the previous month.\n15. Have acute exacerbation of chronic obstructive lung disease stage III or IV (Gold classification), Have cognitive or language barriers that prohibit obtaining informed consent or any study elements.\n16. Severe acute infection at time of screening and treatment with study drug\n17. Pregnant or Breastfeeding\n18. Currently participating (or participated within the previous 30 days of consent) in an investigational therapeutic or device trial.\n19. Have a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the patient's participation for the full duration of the study.","18 Years",{"count":52,"type":22},30,[25,26],"The goal of this ongoing open-label, single-arm, phase I\u002FIIa study in patients is designed to assess the safety of human allogeneic BM-derived MSCs product StromaForte for musculoskeletal injury or\u002Fand degeneration. Any male or female with any musculoskeletal injury and\u002For degeneration above 18 years will be enrolledThe main questions it aims to answer are:\n\nTo assess the safety after 28±10, 84±10, 168±10 and 349±10 days of injection by reporting the number of adverse events or severe adverse event assessed by Common Terminology Criteria\n\nChange from baseline in subjective pain assessment in each injured and\u002For degenerated area (if multiple injury is reported, each area to be followed up separately)\n\nEligible patients will receive 50 x 106 allogeneic bone marrow (BM)-derived MSC formulated in 4 ml infusion solution of sodium chloride supplemented with human serum albumin to be given locally under ultrasound guidance along with or without 100 x 106 allogeneic BM-derived MSCs formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion in approximately 30 min. Systemic treatment alone is used when local injection at site of injury is not feasible. Additional dose can be administered.",[56],"Musculoskeletal Injury",{"date":33,"type":34},{"date":59,"type":34},"2023-10-20",{"date":61,"type":22},"2028-10-19",{"name":40,"class":41},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":16,"sex":70,"minAge":71,"maxAge":19,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":42},"100521510","phase-1-a-study-of-human-allogeneic-bone-marrow-derived-mesenchymal-stromal-cell-product-stromaforte-in-patients-with-aging-frailty-100521510","NCT06070532","A Study of Human Allogeneic Bone-marrow-derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Aging Frailty","A Patient Sponsored Ongoing Open-label Single-arm, Safety and Efficacy, Phase I\u002FIIa Clinical Study of Cellcolabs' Human Allogeneic Bone-marrow-derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Aging Frailty","Inclusion Criteria:\n\n* Willing and able to provide written informed consent and comply with all procedures required by the protocol\n* Aged \\> 60 and \\\u003C 85 years at the time of signing the informed consent form\n* Have a Canadian Study on Health and Aging (CSHA) Clinical Frailty Scale score of 5 \"mildly frail\" or 6 \"moderately frail\"\n* Have a 6-minute walk distance of \\> 200m and \\\u003C 400 m\n* Have a serum TNF-alpha level \\>2.5 pg\u002Fm\n\nExclusion Criteria:\n\n1. Unwilling or unable to perform any of the assessments required by the protocol\n2. Have a diagnosis of any disabling neurologic disorder, including, but not limited to, Parkinson's disease, Amyotrophic Lateral Sclerosis, multiple sclerosis, cerebrovascular accident with residual deficits (e.g., muscle weakness or gait disorder), or diagnosis of dementia\n3. Have a score of 24 or lower on the Mini Mental State Examination (MMSE)\n4. Have poorly controlled blood glucose levels (HbA1c \\>8.0%).\n5. Have a clinical history of malignancy within 2.5 years (i.e., patients with prior malignancy must be cancer free for 2.5 years) except curatively treated basal cell carcinoma, melanoma in situ, or cervical carcinoma.\n6. Have any condition that limits lifespan to \\\u003C 1 year according to the Principal Investigator's discretion\n7. Have autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus).\n8. Undergoes chronic immunosuppressant therapy such as high-dose corticosteroids or TNF-alpha antagonists (prednisone use at doses of \\\u003C 5 mg daily is allowed)\n9. Hepatitis B virus positive\n10. Viraemic Hepatitis C virus, HIV-1\u002F2 or syphilis positive\n11. Have a resting blood oxygen saturation of \\\u003C93% (measured by pulse oximetry).\n12. Known or suspected alcohol or drug abuse within three years preceding Screening\n13. Have a known hypersensitivity to dimethyl sulfoxide (DMSO).\n14. An organ transplant recipient (other than transplantation for corneal).\n15. Actively listed (or expected future listing) for transplant of any organ (other than corneal transplant).\n16. Have any clinically important abnormal screening laboratory values, including, but not limited to: i. Haemoglobin \\\u003C10.0 g\u002FdL, ii. White blood cell \\\u003C2,500\u002Ful, or platelet count \\\u003C100,000\u002Ful iii. Liver dysfunction evidenced by enzymes (AST and ALT) \\> 3 times the upper limit of normal (ULN)\n17. Coagulopathy with an international normalized ratio (INR) \\>1.3 is not due to a reversible cause (e.g., warfarin and\u002For Factor Xa inhibitors).\n18. Uncontrolled hypertension (resting systolic blood pressure \\>180 mm Hg or diastolic blood pressure of \\> 110 mm Hg at screening)\n19. Have unstable angina pectoris, uncontrolled or severe peripheral artery disease within the previous 3 months.\n20. Have congestive heart failure defined by New York Heart Association (NYHA) Class III or IV, or an ejection fraction of \\\u003C25%.\n21. Have a coronary artery bypass surgery, angioplasty, peripheral vascular disease revascularization, or a myocardial infarction within the previous 3 months\n22. Have severe pulmonary dysfunction: acute exacerbation of chronic obstructive lung disease stage III or IV (Gold classification), and\u002For PaO2 levels \\\u003C60 mmHg.\n23. Have a partial ileal gastric bypass or other significant intestinal malabsorption.\n24. Have advanced liver or renal disease\n25. Have cognitive or language barriers that prohibit obtaining informed consent or any study elements.\n26. Currently hospitalized or living in an assisted living facility or a long-term care facility.\n27. Currently participating (or participated within the previous 30 days of consent) in an investigational therapeutic or device trial.\n28. Have a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the patient's participation for the full duration of the study","MALE","60 Years",{"count":73,"type":22},12,[25,26],"The goal of this phase I\u002FII clinical trial is to evaluate the safety and tolerability of intravenous infusion of human allogeneic bone-marrow-derived mesenchymal stromal cell product StromaForte in patients with aging frailty. The main questions it aims to answer are:\n\nTo assess the safety and tolerability after 28 days of injection by reporting the number of adverse events assessed by Common Terminology Criteria For Adverse Events (CTCAE)\n\nObserve the change in inflammatory markers from baseline to 6 months (baseline to 28, 84, and 168 days post-infusion.)\n\nParticipants will receive 100 x 106 allogeneic bone marrow (BM)-derived Mesenchymal Stromal Cell (MSC) formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion 100 million cells in approximately 30 min",[77],"Frailty","NOT_YET_RECRUITING",{"date":80,"type":34},"2024-04-18",{"date":82,"type":22},"2025-01-01",{"date":84,"type":22},"2027-01-10",{"name":40,"class":41},""]