Role of UC-MSC and CM to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II

Launched by PT. PRODIA STEM CELL INDONESIA · Jun 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for Retinitis Pigmentosa, a condition that can lead to vision loss. Researchers are testing two different doses of stem cells taken from umbilical cord tissue to see if they can help preserve vision. There are two groups in the study: one group will receive 1.5 million cells, and the other group will receive 5 million cells. Both groups will have 30 participants and will receive injections near their eyes. Everyone will be monitored for six months to see how well the treatment works.

To participate, individuals should have a certain level of vision and specific measurements of their eye function. Eligible participants must be willing to undergo several eye tests and sign consent forms. However, pregnant or nursing women, those with certain medical conditions or eye diseases, and individuals taking certain medications cannot take part in this trial. Overall, this study aims to explore a potential new way to help people with Retinitis Pigmentosa, and participants will play an important role in this research.

Gender

ALL

Eligibility criteria

• 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)