Neurogenesis Induction with a Combination of Conditioned Medium and UCMSC as a New Strategy for Ischemic Stroke
Tahapan Penelitian : Recruit
Sponsor:
PT. Prodia StemCell Indonesia
Mitra Pelaksana:
Gatot Soebroto Army Hospital
No Registry
INA-8LHBKOCM
Tanggal Input Registry : 17-02-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 30-05-2022 |
| Outcome Primer | The administration of Conditioned Medium (CM) and transplantation of Umbilical Cord Mesenchymal Stem Cells (UCMSC) can improve clinical outcomes as observed in the improvement of NIHSS scores, mRS, increased levels of the biomarker BDNF (Brain Derived Neurotrophic Factor), enhanced formation of new capillaries in the infarct area, as indicated by the increased biomarker VEGF (Vascular Endothelial Growth Factor), and reduced inflammation in the infarct area, as seen in the decreased serum levels of IL-6 and TNF-alpha. |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | Neurogenesis Induction with a Combination of Conditioned Medium and UCMSC as a New Strategy for Ischemic Stroke |
| Judul Penelitian Ilmiah | Neurogenesis Induction with a Combination of Conditioned Medium and UCMSC as a New Strategy for Ischemic Stroke |
| Jenis Penelitian | Interventional |
| Intervensi | Group 1: Umbilical Cord Mesenchymal Stem Cells (UCMSC) Group 2: Umbilical Cord Mesenchymal Stem Cells(UCMSC) + Conditioned Medium Umbilical Cord Mesenchymal Stem Cells (CM-UCMSC) Group 3: No treatment (control) |
| Jumlah Subyek Penelitian | 15 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Male or female aged 25-65 years diagnosed with acute or subacute ischemic stroke, the patient has undergone a CT scan/MRI of the brain to assess the ischemic territory, the patient must have an NIH Stroke score of 8-20, the patient or their legal guardian has received detailed informed consent regarding the research protocol and agrees to participate in the study, the patient has a GCS score > 8, and the patient has a Pt-APTT value within normal limitsExclusion Criteria: Patients with recurrent stroke within 6 months prior to the current stroke episode, CT or MRI findings showing midline shift and hemorrhagic transformation, participating in a similar study using CM and/or UC-MSC, patients with immunocompromised conditions and/or those receiving immunosuppressive therapy, patients who cannot undergo CT or MRI examination due to any condition, patients with kidney and liver dysfunction after the onset of ischemic stroke: SGOT and SGPT >5 times the upper limit of normal, and significant increase in urea-creatinine levels, and patients with a history of malignant tumors or other severe neurocognitive diseases. |
| Administrative Information | |
| Nomor Persetujuan Etik | 34/VI/KEPK/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 |