Role of Umbilical Cord-derived Stem Cell Transplantation and Conditioned Medium to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II

Tahapan Penelitian : Initial
Sponsor:
Mitra Pelaksana:
Dr. Sardjito General Hospital
No Registry
INA-90Z3YBWW
Tanggal Input Registry : 12-02-2025

01-06-2025
Improve retinal function
Patients Quality of Life
 
Role of Umbilical Cord-derived Stem Cell Transplantation and Conditioned Medium to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II
Role of Umbilical Cord-derived Stem Cell Transplantation and Conditioned Medium to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II
Interventional
EyeSTEM 001-X (1 million Umbilical cord-derived mesenchymal stem cells) EyeSTEM 001-XF (5 million Umbilical cord-derived mesenchymal stem cells)
60
 

Inclusion Criteria:

Visus more than 20/100, Have more than 0.68 uV on conical receptor cell amplitude checked by ERG Visual field equivalent diameter more than 10o, 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 questionnaire

Exclusion Criteria:

Pregnant or nursing women, Positive result of HIV test, Have a history of eye tumors, Under 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)
 
KE/FK/0247/EC/2023
Not applicable
Not applicable
Rima Haifa, S.Si, M. Farm-Klin