The Use of Umbilical Cord-Derived Mesenchymal Stem Cells as an Adjuvant Therapy for Group E COPD Patients Undergoing Standard Treatment
Tahapan Penelitian : Recruit
Sponsor:
PT Prodia StemCell Indonesia
Mitra Pelaksana:
RSUP Persahabatan
No Registry
INA-78XT32DH
Tanggal Input Registry : 04-03-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 17-01-2025 |
| Outcome Primer | UC-MSCs can enhance quality of life, augment lung function, and refine radiological imaging. |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | The Use of Umbilical Cord-Derived Mesenchymal Stem Cells as an Adjuvant Therapy for Group E COPD Patients Undergoing Standard Treatment |
| Judul Penelitian Ilmiah | The Use of Umbilical Cord-Derived Mesenchymal Stem Cells as an Adjuvant Therapy for Group E COPD Patients Undergoing Standard Treatment |
| Jenis Penelitian | Interventional |
| Intervensi | Umbilical Cord Mesenchymal StemCell (UC-MSC) Group and Controlled Group |
| Jumlah Subyek Penelitian | 20 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: - Male or female - Aged 40–75 years - Diagnosed with Group C or D COPD according to GOLD 2021 - In a stable condition for at least the last two weeks before study enrollmentExclusion Criteria: - Smokes or quit 2× upper limit) - HIV-positive - Severe renal failure (creatinine >1.5× upper limit) - Pregnant or breastfeeding - Serious comorbidities (diabetes HbA1C >7%, MI, unstable angina, cirrhosis, glomerulonephritis) - Leukopenia or agranulocytosis - Mental disorders, suicide risk, epilepsy, or CNS disorders - History of alcohol or drug abuse - Participated in another clinical trial |
| Administrative Information | |
| Nomor Persetujuan Etik | 126/KEPK-RSUPP/09-2023 |
| 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 |