[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cytori Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":80},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100620683","safety-and-efficacy-of-adipose-derived-regenerative-cells-adrcs-for-improving-hand-dysfunction-in-systemic-sclerosis-100620683",false,"NCT07360808","Safety and Efficacy of Adipose-Derived Regenerative Cells (ADRCs) for Improving Hand Dysfunction in Systemic Sclerosis","Safety and Efficacy of Autologous Adipose-Derived Regenerative Cells (ADRCs) for Improving Hand Dysfunction in Systemic Sclerosis: A Prospective, Randomized, Multicenter Superiority Trial","AEGIS","Inclusion Criteria:\n\n1. Age 18-70 years old (inclusive), gender not restricted;\n2. According to the 2013 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) systemic sclerosis (SSc) diagnostic criteria, diagnosed as diffuse cutaneous type or localized cutaneous type;\n3. Thickened hand skin, modified Rodnan skin score ≥ 8 points and ≤ 35 points;\n4. Cochin Hand Function Scale (CHFS) ≥ 20 (total score 90), with or without skin ulcers;\n5. Capable of safely undergoing liposuction to obtain sufficient adipose tissue (the preferred fat extraction sites are the abdomen, followed by the lateral abdomen, inner and outer thighs, posterior thighs, and anterior thighs; multiple sites can be selected for liposuction to obtain sufficient adipose tissue);\n6. Voluntary participation in this clinical trial and signing the informed consent form by the subject.\n\nExclusion Criteria:\n\n1. Subject's body mass index (BMI) \\\u003C 17 kg\u002Fm\\^2;\n2. Hand skin lesions are in the atrophic stage, and the investigator determines that they are not suitable for hand drug injection;\n3. Any finger contracture or injection site ulcer that makes it unsafe to complete the injection;\n4. Any proximal to distal interphalangeal joint amputation of any finger, or amputation of more than one finger;\n5. Concurrent other rheumatic immune diseases, such as RA, SLE, dermatomyositis, etc. (existing rheumatic immune diseases that do not affect the safety and efficacy evaluation of the hand and do not affect the safety of the hand and efficacy evaluation, excluding Sjögren's syndrome);\n6. Active infectious diseases or patients who have used antibiotics within 3 months before the screening visit due to active infectious diseases;\n7. Patients with unstable systemic sclerosis who have received cell therapy before the screening visit;\n8. Patients who have undergone chemotherapy or resection of malignant cancer within 5 years before the screening visit;\n9. Abnormal tumor markers detected during the screening period, and the investigator determines that there is a tumor risk;\n10. Patients who have received CD20 monoclonal antibody treatment within 1 year before the screening visit, or have used other biologic drugs or taken small molecule targeted drugs within 3 months before the screening visit (excluding those who have maintained a stable dose of ≥ 3 months at the time of enrollment for systemic sclerosis treatment);\n11. Have received hand cell injection therapy before, or are intolerant to cell therapy, or have received systemic cell injection therapy within 6 months before the screening visit;\n12. Patients with positive human immunodeficiency virus antibody (anti-HIV-Ab) test results, active syphilis, active hepatitis C (HCV-RNA positive, and hepatitis C antibody positive), hepatitis B (HBsAg positive and HBV-DNA positive) during the screening period;\n13. There is evidence indicating that the subject currently has possible safety-related diseases in the digestive system, urinary system, cardiovascular system, hematological system, nervous system, mental state, and metabolism, such as poorly controlled diabetes, poorly controlled hypertension, etc.;\n14. Any of the following laboratory test results during the screening period: ① Abnormal blood routine: hemoglobin \\\u003C 80 g\u002FL; white blood cell count \\\u003C 3.0 × 10\\^9\u002FL; absolute neutrophil count \\\u003C 1.2 × 10\\^9\u002FL; platelet count \\\u003C 100 × 10\\^9\u002FL; ② Abnormal liver and kidney function: aspartate transaminase (AST), alanine aminotransferase (ALT), activated partial thromboplastin time (APTT) prolonged \\> 1.5 times the upper limit of the reference value; ③ Coagulation dysfunction: prothrombin time (PT) and partial thromboplastin time (APTT) prolonged \\> 1.8 times the upper limit of the reference value, or international normalized ratio (INR) \\> 2;\n15. Allergic to any component of human albumin, anesthetic drugs, or human adipose-derived mesenchymal stem cell injection solution, or the investigator determines that the subject is not suitable for enrollment due to a severe allergy history;\n16. Patients whose screening visit is within 3 months before the general anesthesia surgery planned during the study period;\n17. Patients who have participated in other clinical studies within 3 months before the screening visit, or are currently participating in other clinical studies;\n18. Pregnant women, lactating women, those with positive pregnancy test results, or those who do not agree to use effective contraceptive measures during the study period and within 6 months after the trial;\n19. Patients judged by the investigator to be unsuitable to participate in this study.","ALL","18 Years","70 Years",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"NA","This prospective, randomized, blinded, multicenter clinical study aims to evaluate the safety and efficacy of autologous adipose-derived regenerative cells (ADRCs) in improving hand dysfunction in patients with systemic sclerosis (SSc). The study plans to enroll 48 eligible patients, randomly assigned to two groups. The experimental group will receive ADRCs, prepared from the Celution system, which is injected into specific sites on each finger of both hands. The control group will receive standard care according to established treatment guidelines. The primary endpoint is the change from baseline in the Cochin Hand Function Scale (CHFS) score at 24 weeks. Secondary endpoints include assessments of skin thickness, Raynaud phenomenon, hand strength, quality of life, pain, and other measures at various time points. Safety and device performance will be monitored throughout the study. This investigation seeks to explore a new potential therapeutic direction for managing hand dysfunction in systemic sclerosis.",[28,29],"Systemic Sclerosis (SSc)","Hand Dysfunction",[31,32,33,34],"Adipose-Derived Regenerative Cells (ADRCs)","Systemic Sclerosis","Hand Function","Raynaud Condition","RECRUITING","2026-01-17",{"date":38,"type":39},"2026-01-22","ACTUAL",{"date":41,"type":39},"2025-12-31",{"date":43,"type":22},"2027-12-31",{"name":45,"class":46},"Cytori Therapeutics","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100601990","safety-and-efficacy-of-autologous-adipose-derived-regenerative-cells-adrcs-injection-for-improving-diminished-ovarian-reserve-100601990","NCT07117682","Safety and Efficacy of Autologous Adipose-Derived Regenerative Cells (ADRCs) Injection for Improving Diminished Ovarian Reserve","Safety and Efficacy of Autologous Adipose-Derived Regenerative Cells (ADRCs) Injection for Improving Diminished Ovarian Reserve (ARISE) - A Single-arm Self-controlled Study","ARISE-01","Inclusion Criteria:\n\n1. Female patients aged 20-39 years.\n2. Diagnosed with DOR, defined as AFC \\\u003C 7 and\u002For AMH ≤ 1.1 ng\u002FmL.\n3. FSH ≤ 40 U\u002FL.\n4. Have signed informed consent for the clinical trial.\n5. In good general health and able to tolerate local anesthesia, liposuction, oocyte retrieval, as well as pregnancy and childbirth.\n6. Without relative contraindications to fertility such as hereditary tumor-related diseases.\n\nExclusion Criteria:\n\n1. Presence of thyroid disorders.\n2. Body Mass Index (BMI) \\\u003C 18 kg\u002Fm².\n3. Confirmed pregnancy (positive β-hCG with ultrasound confirmation of embryo implantation).\n4. History of autoimmune diseases.\n5. Family history of ovarian tumors.\n6. Prior pelvic or systemic radiotherapy for cancer treatment.\n7. Positive serology\u002Fvirology results for human immunodeficiency virus (HIV), Hepatitis C, Hepatitis B, Syphilis, human papillomavirus (HPV), or abnormal ThinPrep cytology (TCT).\n8. DOR caused by genetic disorders.\n9. Reproductive system pathologies including polycystic ovary syndrome (PCOS), adenomyosis, uterine fibroids ≥ 5 cm, endometrial carcinoma, or uterine malformations.\n10. Contraindications to liposuction.\n11. Abnormal semen analysis of the male partner precluding natural conception or conception via assisted reproductive technology (ART).\n12. Malignancy-related conditions such as active malignancy without complete remission or chemotherapy administration within the past 6 months.","FEMALE","40 Years",{"count":58,"type":22},25,[25],"Diminished Ovarian Reserve (DOR) poses significant challenges to fertility and hormonal health, with limited effective treatments. This prospective, self-controlled clinical study evaluates the safety and efficacy of intraovarian injection of autologous Adipose-Derived Regenerative Cells (ADRCs) to improve ovarian function in reproductive-aged women with DOR.\n\nThe ARISE trail enrolled 25 women aged \\\u003C40 years meeting clinical criteria for DOR, excluding those with severe comorbidities. Autologous adipose tissue was harvested via liposuction, and ADRCs were isolated using the Celution® system before bilateral ovarian medulla injection. Participants underwent follow-up at multiple time points up to 12 months post-procedure.\n\nPrimary outcomes included cumulative clinical pregnancy rates (natural or via ART) within 12 months and 1-, 2-, 3-, 6-month changes in ovarian reserve markers (FSH, AMH, antral follicle count) in non-pregnant patients. Secondary outcomes encompassed ovarian reserve markers at 12 months, as well as menstrual pattern recovery and ovarian volume changes at 1, 2, 3, 6, 12 months. Adverse events (AEs) will be monitored at each time point.\n\nStatistical analyses followed standard principles, including mixed models for repeated measures and appropriate tests for subgroup comparisons. Sample size was determined based on feasibility and prior effect size estimates to ensure adequate power.\n\nThis study provides novel insights into regenerative therapies for DOR, emphasizing safety and functional restoration.",[62,63,64],"Diminished Ovarian Reserve (DOR)","Primary Ovarian Insufficiency (Poi)","Ovarian Failure, Premature",[66,67,68,69,70],"Diminished Ovarian Reserve","Adipose-Derived Regenerative Cells","anti-Müllerian hormone","follicle-stimulating hormone","antral follicle count","NOT_YET_RECRUITING","2025-08-05",{"date":74,"type":39},"2025-08-12",{"date":76,"type":22},"2025-08-25",{"date":78,"type":22},"2027-08-01",{"name":45,"class":46},""]