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-5AXHF2RP
Tanggal Input Registry : 31-01-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 15-01-2022 |
| Outcome Primer | Improving insulin resistance in PCOS patients resulting in 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 Cord Mesenchymal StemCell (UC-MSC) and Conditioned Medium Umbilical Cord Mesenchymal StemCell (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 > 1.7.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 HI |
| Administrative Information | |
| Nomor Persetujuan Etik | 54/III/KEPK/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 |