Long-term Safety of UC-MSC Transplantation in Patients With Retinitis Pigmentosa
Tahapan Penelitian : Initial
Sponsor:
PT Prodia StemCell Indonesia
Mitra Pelaksana:
Dr. Sardjito General Hospital
No Registry
INA-4BPPPEEP
Tanggal Input Registry : 12-02-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 01-03-2025 |
| Outcome Primer | Improve retinal function |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | Long-term Safety of UC-MSC Transplantation in Patients With Retinitis Pigmentosa |
| Judul Penelitian Ilmiah | Long-term Safety of UC-MSC Transplantation in Patients With Retinitis Pigmentosa |
| Jenis Penelitian | Observational |
| Intervensi | |
| Jumlah Subyek Penelitian | 18 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Visual field defects at the initial examination with Humphrey perimetry are between 25% to 50%, Willing to sign informed consent as research subjects, Willing to do the peribulbar injection with mesenchymal stem cells isolated from umbilical cord tissue, Willing to do visual field checks with Humphrey's perimetry, vision tests with Snellen boards; Optical Coherent Tomography (OCT) examinations; electroretinogram examinations; and fill out a quality of life questionnaireExclusion Criteria: Pregnant or nursing women, Positive result of HIV test, Have a history of eye tumors, In the immunosuppressive treatment or other drugs that can affect the growth of transplanted stem cells, Have another eye disease such as diabetic retinopathy; uveitis; cataract; and glaucoma, Do not come to control according to the schedule determined by the researcher (loss to follow up) |
| Administrative Information | |
| Nomor Persetujuan Etik | KE/FK/0168/EC/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 |