Umbilical Cord Mesenchymal Stem Cell Therapy and Secretome as Immunotherapy in Polycystic Ovary Syndrome (PCOS) Patients with Insulin Resistance
Tahapan Penelitian : Complete
Sponsor:
PT. Prodia StemCell Indonesia
Mitra Pelaksana:
Gatot Soebroto Army Hospital
No Registry
INA-6XRFEC60
Tanggal Input Registry : 31-01-2025
Tracking Information | |
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Tanggal Antisipasi Studi | 15-09-2022 |
Outcome Primer | Improving insulin resistance in PCOS patients, leading to improvements in menstrual cycles and fertility |
Outcome Skunder | |
Descriptive Information | |
Judul Penelitian Popular | Umbilical Cord Mesenchymal Stem Cell Therapy and Secretome as Immunotherapy in Polycystic Ovary Syndrome (PCOS) Patients with Insulin Resistance |
Judul Penelitian Ilmiah | Umbilical Cord Mesenchymal Stem Cell Therapy and Secretome as Immunotherapy in Polycystic Ovary Syndrome (PCOS) Patients with Insulin Resistance |
Jenis Penelitian | Interventional |
Intervensi | Umbilical Cor Mesenshymal Stem Cell (UCMSC) and Conditioned Medium Umbilical Cor Mesenshymal Stem Cell (CM-UCMSC) |
Jumlah Subyek Penelitian | 40 |
Recruitment Information | |
Eligibility Criteria | Inclusion Criteria: PCOS patients with insulin resistance are diagnosed based on the Rotterdam Consensus criteria, which include menstrual disturbances (oligomenorrhea/amenorrhea),clinical and laboratory evidence of hyperandrogenemia, Free Androgen Index (FAI) > 4, and polycystic ovaries observed through transvaginal ultrasound, HOMA IR score > 1.Exclusion Criteria: Patient is allergic to one of the components of UC-MSC or its secretome, not undergoing hormone treatment or other insulin resistance treatments, refuses or does not comply with some/all of the study process, diagnosed positive for hepatitis A, B, C, and HIV. |
Administrative Information | |
Nomor Persetujuan Etik | 54/KEPK/III/2024 |
Nomor Persetujuan Material Transfer Agreement | Not applicable |
Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
Other Study ID Numbers | |
Contact Person | Rima Haifa,S,Si.,M.Farm-Klin |