NCT05909488

Role of UC-MSC and CM 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

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: PT. Prodia Stem Cell Indonesia · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study will perform UC-MSCs and CM transplantation. There are two groups with different dosages. The first group will be transplanted with 1.5 million cells, meanwhile, the second group is 5 million cells. Each group consists of 30 subjects. All groups will be transplanted via the peribulbar route. All groups will be observed until six months.

Detailed description

The eyes we will give the transplant should be given an aseptic and antiseptic technique to prevent contamination from the inside and outside. Sterile cover attached to other parts of the face except for the eyes. 1.8 ml Umbilical Cord-derived Mesenchymal Stem Cell (UC-MSC) preparations are suspended in Conditioned Medium (CM) until it reaches a 2 ml volume of cell suspension. Two dosages will be prepared, 1.5 million and 5 million of UC-MSC. Stem cell suspension will be injected by peribulbar, and patients will be given a quinolone antibiotic if the injection is done. On day 1st and day 7th after therapy, patients will be observed the presence of infection, inflammation, and increased eye pressure. On day 7th, day 30th, and day 90th after therapy, patients will do a visual field test, visual acuity test, electroretinography, funduscopy, and Optical Coherence Tomography examination. The observations will be written in the table and analyzed by a statistic.

Conditions

• Retinitis Pigmentosa

Interventions

Type	Name	Description
BIOLOGICAL	1.5 x 10^6 UC-MSC + CM	1.5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)
BIOLOGICAL	5 x 10^6 UC-MSC + CM	5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-07-01
• Completion: 2027-09-01
• First posted: 2023-06-18
• Last updated: 2026-02-25

Locations

1 site across 1 country: Indonesia