Mesenchymal Stem Cell Therapy (MSCs) and Conditioned Medium Therapy for Osteoartrithis (OA)
Tahapan Penelitian : Recruit
Sponsor:
PT. Prodia StemCell Indonesia
Mitra Pelaksana:
Gatot Soebroto Army Hospital
No Registry
INA-2FYRN804
Tanggal Input Registry : 31-01-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 28-09-2022 |
| Outcome Primer | Reduced pain during rehabilitation and joint inflammation, with differences in knee joint functional scores and inflammatory enzyme levels after therapy with UC-MSCs and CM UC-MSCs. |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | Mesenchymal Stem Cell Therapy (MSCs) and Conditioned Medium Therapy for Osteoartrithis (OA) |
| Judul Penelitian Ilmiah | Mesenchymal Stem Cell Therapy (MSCs) and Conditioned Medium Therapy for Osteoartrithis (OA) |
| Jenis Penelitian | Interventional |
| Intervensi | BIOLOGICAL: Arthroscopy with MSC + Secretome + Secretome BIOLOGICAL: Arthroscopy with Secretome + MSC + Secretome BIOLOGICAL: Non Arthroscopy with MSC + Secretome + Secretome BIOLOGICAL: Non Arthroscopy with Secretome + MSC + Secretome BIOLOGICAL: Arthroscopy with Placebo BIOLOGICAL: Non Arthroscopy with Placebo |
| Jumlah Subyek Penelitian | 30 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: OA patients with Grade 2-3 OA were identified by two different observers according to the Kellgren-Lawrence research scale.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 | 105/VIII/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 |