The Effectiveness of Umbilical-derived Mesenchymal Stem Cell Secretome Administration for Traumatic Brain Injury
Tahapan Penelitian : Recruit
Sponsor:
PT. Prodia StemCell Indonesia
Mitra Pelaksana:
Central Army Hospital Gatot Soebroto
No Registry
INA-981PW2KB
Tanggal Input Registry : 21-03-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 02-08-2024 |
| Outcome Primer | Changes in biomarker serum (Brain Derived Nerve Factor (BDNF), Vascular Endothelial Growth Factor (VEGF), Interleukin-6 (IL-6), and Tumor Necrosis Factor-Alfa (TNF-Alfa) and S100B serum) |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | The Effectiveness of Umbilical-derived Mesenchymal Stem Cell Secretome Administration for Traumatic Brain Injury |
| Judul Penelitian Ilmiah | The Effectiveness of Umbilical-derived Mesenchymal Stem Cell Secretome Administration for Traumatic Brain Injury |
| Jenis Penelitian | Interventional |
| Intervensi | Conditioned Medium Umbilical Cord Mesenchymal StemCell (CM-UCMSC) |
| Jumlah Subyek Penelitian | 30 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Male or female aged < 60 years at the time of TBI diagnosis, type of trauma: blunt and closed head injury, the patient or accompanying person has received detailed informed consent regarding the research protocol and agrees to participate in the study, the patient has a moderate GCS score between 9-12, no severe trauma to other organs, the accompanying person is able to understand the research explanation by signing a written informed consent, the accompanying person is willing to return for follow-up examinations as per the scheduled appointments.Exclusion Criteria: Participation in similar studies using CM and/or UC-MSC, patients with immunocompromised conditions and/or those receiving immunosuppressive therapy, patients who cannot undergo CT or MRI examinations due to any condition, history of previous head injury, presence of hemodynamic instability that cannot be corrected during screening, and presence of severe coagulation disorders that cannot be corrected during screening. |
| Administrative Information | |
| Nomor Persetujuan Etik | 63/IV/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 |