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drugset / Trial / NCT04315025

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

NCT04315025 ↗

Phase 1/2 Completed 18 enrolled PT. Prodia Stem Cell Indonesia
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2018-10-07
Primary completion
2019-06-20
Completion
2019-09-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Secretome Other / unclassified 2 ml Other
Comparator Umbilical Cord Mesenchymal Stem Cell Cell therapy 1e+06 cells Other

Indications

retinitis pigmentosa