Status:

UNKNOWN

The Effect of Stem Cells and Stem Cell Exosomes on Visual Functions in Patients With Retinitis Pigmentosa

Lead Sponsor:

TC Erciyes University

Conditions:

Retinitis Pigmentosa

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

PHASE3

Brief Summary

This clinical trial aims to study the efficacy of umbilical cord-derived mesenchymal stem cells and their exosomes in the treatment of retinitis pigmentosa. The participants will be randomized into 3 ...

Detailed Description

Retinitis pigmentosa (RP) is one of the leading causes of vision loss and irreversible blindness. It is stated that 1.4 million people are affected in the world and its prevalence is 1:4000. Stem cell...

Eligibility Criteria

Inclusion

  • 18 years and over,
  • Diagnosis of retinitis pigmentosa: by clinical history, fundus examination, visual field (GA), electroretinogram (ERG), and genetic analysis
  • Visual field loss
  • The best corrected visual acuity of 0.05 on the Snellen chart
  • The MD (mean deviation) value in the visual field is between 33.0 and -5.0 dB
  • Intraocular pressure value below 22 mmHg

Exclusion

  • Presence of cataracts or other media opacities that may affect imaging and tests
  • Diagnosis of glaucoma
  • History of ocular surgery or injection in the last 6 months
  • Visual level too low for examinations (0.05 and below)
  • Diagnosis of any systemic disease (such as diabetes, uncontrolled hypertension, neurological disease)
  • Smoking and substance abuse

Key Trial Info

Start Date :

August 5 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 15 2023

Estimated Enrollment :

135 Patients enrolled

Trial Details

Trial ID

NCT05413148

Start Date

August 5 2022

End Date

December 15 2023

Last Update

September 7 2022

Active Locations (1)

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1

Erciyes University, Faculty of Medicine

Kayseri, Turkey (Türkiye), 38039