[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hope Biosciences Research Foundation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100598919","phase-2-hb-admscs-for-the-treatment-of-crohns-disease-100598919",false,"NCT07077746","HB-adMSCs for the Treatment of Crohn's Disease","A Randomized, Double-Blind, Phase 2, Efficacy and Safety Study of Allogeneic HB-adMSCs vs Placebo for the Treatment of Crohn's Disease","Inclusion Criteria:\n\n1. Male and female subjects who are ≥ 18 years old and ≤ 65 years old.\n2. Must be diagnosed with Crohn's Disease at least 6 months prior to the screening visit, as verified by one or more of the following diagnostic criteria present in the participant's medical records:\n\n   1. Clinical presentation of symptoms such as diarrhea, abdominal pain, weight loss, fever, and fatigue\n   2. Radiologic Findings within 3 years of screening date: Imaging studies like CT scans or MRI scans of the abdomen and pelvis that indicate bowel wall thickening, strictures, fistulas, and abscesses characteristic of Crohn's disease\n   3. Histologic Findings within 3 years of screening date: Microscopic examination of tissue biopsies that indicate transmural inflammation with lymphoid infiltrates\n   4. Exclusion of other conditions: Differential diagnoses, such as ulcerative colitis, infectious enterocolitis, and drug-induced colitis, must be excluded through appropriate evaluation\n3. Must have CDAI scores at the screening visit of ≥ 150 to ≤ 450, indicating Mild or Moderate Crohn's Disease.\n4. Subjects without a current established treatment for Crohn's Disease, or if being treated, subjects who are on a stable dose of Crohn's Disease therapy regimen for ≥3 months prior to screening.\n5. Subjects must be willing to maintain their established treatment for Crohn's Disease (or lack thereof) for the duration of the study. Subjects must acknowledge that they may be removed from participation in the study for failure to maintain their established treatment for Crohn's Disease (or lack thereof).\n6. Subjects must have an elevated CRP value at the screening visit of ≥1 mg\u002FL and\u002For an abnormal ESR value at the screening visit of \\> 15 mm\u002Fhr. for male subjects or \\> 20 mm\u002Fhr. for female subjects.\n7. Subjects must be able to provide the latest (specifically, within 3 years of screening date) diagnostic imaging records for their Crohn's Disease (including but not limited to endoscopy, colonoscopy, MRI scans, ultrasounds, etc.)\n8. Female study subjects of childbearing potential should not be pregnant or plan to become pregnant during study participation and for 6 months after the last investigational product administration. Female study subjects of childbearing potential must confirm usage of one of the following contraceptive measures:\n\n   1. Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).\n   2. Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).\n   3. Barrier contraceptive methods (condoms, diaphragm, etc.). OR Male subjects if their sexual partners can become pregnant should ensure the use one of the following methods of contraception during study participation and for 6 months after the last administration of the investigated product:.\n\n   \u003C!-- -->\n\n   1. Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).\n   2. Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).\n   3. Barrier contraceptive methods (condoms, diaphragm, etc.).\n9. Study subjects are able and willing to comply with the requirements of this clinical trial.\n10. Voluntarily signed informed consent from study subject or legally authorized representative obtained before any clinical-trial related procedures are performed.\n\nExclusion Criteria:\n\n1. Study subject has any of the following laboratory results at the screening visit:\n\n   1. WBC: \\<3000 cells\u002FμL OR \\>15000 cells\u002FμL (\\<3 K cells\u002FμL or \\>15 K cells\u002FμL)\n   2. Absolute Neutrophil Count: \\<1500 cells\u002FμL\n   3. Sodium: \\<120 mEq\u002FL OR \\>150 mEq\u002FL\n   4. Glucose: \\>150 mg\u002FdL (for fasting subjects)\n   5. Potassium: \\<3.5 mEq\u002FL OR \\>6 mEq\u002FL\n   6. BUN: \\>25 mg\u002FdL\n   7. Creatinine: \\>2 mg\u002FdL\n   8. BUN\u002FCreatinine ratio: \\>50\n2. Study subject has CDAI scores of \\< 150 or \\> 450 at the screening visit.\n3. Study participant has any vital sign abnormalities at the screening visit as determined by the investigator.\n4. Study subject has any of the following cardiovascular issues:\n\n   1. Severe heart failure (e.g., NYHA Class III\u002FIV)\n   2. Uncontrolled arrhythmias\n   3. Recent myocardial infarction (\\<6 months from screening visit)\n   4. Uncontrolled hypertension\n5. Study Subject has any of the following pulmonary diseases:\n\n   1. Severe COPD\n   2. Pulmonary fibrosis\n   3. History of recent (\\<6 months from screening visit) pulmonary embolism or DVT\n6. Study subject has 1 or more significant uncontrolled concurrent medical conditions (verified by medical records), including the following:\n\n   1. Diabetes Mellitus\n   2. Rheumatoid Arthritis\n   3. Lupus\n   4. Multiple Sclerosis\n7. Study subject has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma.\n8. Study subject has a history of cancer within 5 years of screening visit (unless curatively treated and without recurrence)\n9. Study subject has known alcoholic addiction or dependency or has current substance use or abuse.\n10. Receiving any investigational therapy or any approved therapy for investigational use within 1 year prior first dose of the investigational product other than COVID-19 vaccines.\n11. Study subject has any other laboratory abnormality or medical condition which, in the opinion of the investigator, poses a safety risk or will prevent the subject from completing the study.\n12. Study subject unable to understand and provide signed informed consent.\n13. Study subject unlikely to complete the study or adhere to the study procedures.\n14. Study subject with known concurrent acute or chronic viral hepatis B or C or human immunodeficiency virus (HIV) infection.\n15. Study subject with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product.\n16. Female subjects who plan to donate eggs or undergo in vitro fertilization treatment during the study within 6 months after the last infusion. OR Male subjects who plan to donate sperm during the study within 6 months after the last infusion.","ALL","18 Years","65 Years",{"count":20,"type":21},46,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Methodology: Randomized, double-blind, efficacy and safety study of allogeneic HB-adMSCs vs placebo for the treatment of Crohn's Disease with a 16-week treatment period and a safety and efficacy follow up period for 52 weeks post first treatment.\n\nTreatment Duration: 16 weeks\n\nGeneral Objectives: To assess the efficacy and safety of multiple intravenous infusions of allogeneic HB-adMSCs by improving signs and symptoms of Crohn's Disease in this subject population.\n\nNumber of Subjects: 46 (23 in each treatment arm)\n\nIndication: Crohn's Disease",[27],"Crohn Disease (CD)",[29,30,31,32,33,34,35,36],"Crohn's","Crohn's Disease","Autoimmune","CD","IBD","Inflammatory bowel disease","biologic","stem cell","RECRUITING","2026-06-15",{"date":40,"type":41},"2026-06-17","ACTUAL",{"date":43,"type":21},"2026-07",{"date":45,"type":21},"2027-12",{"name":47,"class":48},"Hope Biosciences Research Foundation","INDUSTRY",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":4,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":67,"locationsCount":49},"100605589","intermediate-size-patient-population-expanded-access-protocol-to-evaluate-hb-admscs-for-the-treatment-of-patients-with-traumatic-or-nontraumatic-brain-injury-100605589","NCT07164482","Intermediate Size Patient Population Expanded Access Protocol to Evaluate HB-adMSCs for the Treatment of Patients With Traumatic or Nontraumatic Brain Injury","\"An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Allogeneic HB-adMSCs for the Treatment of Patients With Traumatic or Nontraumatic Brain Injury\"","Inclusion Criteria:\n\n1. Male and female patients 14 - 78 years of age\n2. Patient should provide evidence of TBI or non -TBI as evidenced by documentation in their medical records and imaging that was done within the past 3 years.\n3. Female participants of childbearing potential should not be pregnant or plan to become pregnant during protocol participation and for 6 months after the last investigational product administration. Female participants of childbearing potential should confirm the use of one of the following contraceptive measures:\n\n   * Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).\n   * Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).\n   * Barrier contraceptive methods (condoms, diaphragm, etc.).\n   * Surgery (occlusion bilateral tubal ligation, hysterectomy, vasectomized partner).\n\n   OR\n\n   Male participants if their sexual partners can become pregnant should ensure the use one of the following methods of contraception during protocol participation and for 6 months after the last administration of the investigated product:\n   * Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).\n   * Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).\n   * Barrier contraceptive methods (condoms, diaphragm, etc.).\n   * Surgery (vasectomy, occlusion bilateral tubal ligation (partner), hysterectomy (partner)).\n4. Patient\u002FLAR should be able to read, understand, and to provide voluntary consent.\n\nExclusion Criteria:\n\n1. Women who are currently pregnant or lactating.\n2. The patient has any active infection requiring medications per PI's discretion.\n3. The patient has any clinical signs or symptoms of infection per PI's discretion.\n4. The patient has hyperthermia or hypothermia.\n5. The patient has any known recent (within the last 6 months) coagulation anomalies that are not being medically treated and are not stable per PI's discretion.\n6. The patient has any abnormal laboratory values at the screening visit which the Investigator determines to be clinically significant and make the patient unsuitable for participation.\n7. The Investigator determines the patient to be unsuitable for participation for other reasons, such as, but not limited to deep vein thrombosis (DVT), pulmonary embolus, cardiac arrhythmia, or those who have a prothrombotic condition, or who require persistent oxygen supplementation.","14 Years","78 Years","EXPANDED_ACCESS","This expanded access protocol is part of IND 031942 to evaluate efficacy and safety of multiple intravenous administrations of allogeneic HB-adMSCs for the treatment of nontraumatic or traumatic brain injury for up to 8 patients who passed pre-screening, completed screening, and were not randomized into the treatment group for the HBBI01 clinical study protocol entitled, \"An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Allogeneic HB-adMSCs for the Treatment of Patients with Traumatic or Nontraumatic Brain Injury.\" under IND 027396.",[62],"Brain Injury","AVAILABLE","2026-05-15",{"date":66,"type":41},"2026-05-19",{"name":47,"class":48},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":4,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":86,"locationsCount":49},"100611244","an-intermediate-size-patient-population-expanded-access-protocol-to-evaluate-the-safety-and-efficacy-of-allogeneic-hb-admscs-hope-biosciences---adipose-derived-mesenchymal-stem-cells-for-the-treatment-of-multiple-system-atrophy-100611244","NCT07238062","\"An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Allogeneic HB-adMSCs (Hope Biosciences - Adipose Derived Mesenchymal Stem Cells) for the Treatment of Multiple System Atrophy.\"","\"An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Allogeneic HB-adMSCs for the Treatment of Multiple System Atrophy.\"","Inclusion Criteria:\n\n1. Male and female participants 18-85 years of age\n2. Participants must have a diagnosis of \"Clinically Established\" or \"Clinically Probable\" MSA.\n3. Participants must have at least one brain MRI marker suggestive of MSA.\n4. Participants must have both autonomic failure and either poorly L-dopa-responsive parkinsonism or cerebellar ataxia.\n5. Female participants of childbearing potential should not be pregnant or plan to become pregnant during protocol participation and for 6 months after the last investigational product administration. Female participants of childbearing potential should confirm the use of one of the following contraceptive measures:\n\n   * Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).\n   * Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).\n   * Barrier contraceptive methods (condoms, diaphragm, etc.).\n   * Surgery (occlusion bilateral tubal ligation, hysterectomy, vasectomized partner).\n\n   OR\n   * Male participants if their sexual partners can become pregnant should ensure the use one of the following methods of contraception during protocol participation and for 6 months after the last administration of the investigated product:\n   * Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).\n   * Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).\n   * Barrier contraceptive methods (condoms, diaphragm, etc.).\n   * Surgery (vasectomy, occlusion bilateral tubal ligation (partner), hysterectomy (partner)).\n6. Participants should be able to read, understand, and to provide voluntary consent.\n\nExclusion Criteria:\n\n1. Women who are currently pregnant or lactating.\n2. The participant has any active infection requiring medications per PI's discretion.\n3. The participant has any clinical signs or symptoms of infection per PI's discretion.\n4. The participant has hyperthermia or hypothermia.\n5. The participant has any known recent (within the last 6 months) coagulation anomalies that are not being medically treated and are not stable per PI's discretion.\n6. The participant has any abnormal laboratory values at the screening visit which the Investigator determines to be clinically significant and make the patient unsuitable for participation.\n7. The Investigator determines the patient to be unsuitable for participation for other reasons, such as, but not limited to deep vein thrombosis (DVT), pulmonary embolus, cardiac arrhythmia, or those who have a prothrombotic condition, or who require persistent oxygen supplementation.\n8. The participant has a substantial and persistent response to dopaminergic medications.\n9. The participant has unexplained anosmia.\n10. The participant has fluctuating cognition, early dementia, or hallucinations.\n11. The participant has certain eye movement abnormalities.\n12. The participant has any MRI findings that suggest an alternative diagnosis.","85 Years","This expanded access protocol is part of IND 32226 to evaluate efficacy and safety of multiple intravenous administrations of allogeneic HB-adMSCs for the treatment of Multiple System Atrophy for up to 7 adult patients who pass pre-screening and a completed screening. The subjects will receive 12 intravenous infusions of HB-adMSCs and 6 intrathecal injections of HB-adMSCs over the course of 44 weeks (1 infusion each month and 1 injection every other month).",[78],"Multiple System Atrophy",[80,81,82],"msa","stem cells","MSCs","2026-04-14",{"date":85,"type":41},"2026-04-17",{"name":47,"class":48},""]