Safety and Efficacy of Stem Cell Small Extracellular Vesicles in Patients With Retinitis Pigmentosa

Launched by MAHIDOL UNIVERSITY · Feb 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a new treatment for patients with Retinitis Pigmentosa (RP), a condition that affects vision. Researchers are testing a type of treatment called stem cell-derived small extracellular vesicles (sEVs), which are tiny particles that may help improve vision when injected directly into the eye. The trial is currently recruiting participants aged 18 and older who have been diagnosed with RP and have certain vision limitations, such as a very narrow central visual field and specific levels of visual acuity.

To participate, individuals must be willing to give their consent and should not have any serious health issues that could put them at risk during the study. As part of the trial, participants will receive the treatment and will be monitored closely for safety and any changes in their vision. This trial is an important step in exploring new options for people living with RP, and participants will contribute to advancing our understanding of potential therapies for this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 years or above
• • Clinically diagnosed with RP by experienced ophthalmologists or having documented mutations in the genes responsible for RP
• • Central visual field in the better eye less than or equal to 20 degrees
• • Best corrected visual acuity (BCVA) in the worse eye 6/18 (logMAR 0.48) to 6/120 (logMAR 1.3) by Snellen visual acuity chart
• • Electroretinogram in the worse eye nonrecordable or the amplitudes were less than 25% of normal
• • Willing and able to give informed consent for participation in the study
• Exclusion Criteria:
• • Intolerance and/or contraindication to local anesthesia and other substances used during the procedure
• • Pregnant or lactating woman
• • Having blood-borne infections, i.e. Human immunodeficiency virus (HIV), hepatitis B or C, Human T-lymphotropic viruses (HTLV)
• • Having any other significant ocular or non-ocular disease/disorder which may either put the subjects at risk because of participation in the study, or may influence the results of the study, or the subjects ability to participate in the study. This includes
• • 1. Inherited or acquired bleeding disorders, including the use of anticoagulant medications that cannot be stopped prior the procedure
• • 2. Autoimmune diseases, i.e., systemic lupus erythematosus, multiple sclerosis, fibromyalgia, Guillain-Barre syndrome
• • 3. Severe/uncontrolled chronic/metabolic diseases, e.g., diabetes mellitus, cardiovascular disease, chronic kidney disease, transient ischemic attack (TIA)/stroke
• • Unable to complete the full course of the study or failed to return for follow up