NCT04315025

Safety Issues of Peribulbar Injection of UC-MSC in Patients With Retinitis Pigmentosa

Safety Issues of Peribulbar Injection of Umbilical Cord Mesenchymal Stem Cell (UC-MSC) in Patients With Retinitis Pigmentosa

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• 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. The first group will be injected by UCMSC+NaCl. the 2nd group will be injected by UC-MSC+CM. the 3rd group will be injected by CM. Each group consists of 6 subjects. all groups will be transplanted via peribulbar route. the dosage of UC-MSC is 1 million cells for each subject. All groups will be observed until 6 months.

Detailed description

The eyes which will give the transplant should be given an aseptic and antiseptic technique to prevent the contamination from the inside and outside. Sterile cover attached to other parts of the face except for the eyes. 1.8 ml cell preparations are suspended in physiological NaCl until it reaches a total of 2 ml volume of cell suspension (for UC-MSC + NaCl group). Stem cell suspension will be injected by peribulbar and if the injection was done, patients will be given a quinolone antibiotic. On day 1st and day 7th after therapy, patients will be observed the presence of infection, inflammation, and increasing of 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 observation results will be written in the observation table and analyzed by a statistic. After the data was completed, then make a discussion, conclusion, and suggestion of the study.

Conditions

• Retinitis Pigmentosa

Interventions

Type	Name	Description
BIOLOGICAL	Umbilical Cord Mesenchymal Stem Cell (UC-MSC)	Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar
BIOLOGICAL	Conditioned Medium (CM)	Conditioned Medium (CM) injected by peribulbar

Timeline

• Start date: 2018-10-07
• Primary completion: 2019-06-20
• Completion: 2019-09-20
• First posted: 2020-03-19
• Last updated: 2020-06-04

Locations

2 sites across 1 country: Indonesia