Safety and Efficacy Evaluation of Intravitreal Injection of GMP-compliant Bone Marrow Mesenchymal Stem Cell-derived Small Extracellular Vesicles in Patients With Retinitis Pigmentosa
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
The aim of this clinical trials is to evaluate the safety and efficacy of intravitreal injection of GMP-compliant BM-MSC-derived sEVs in patients with retinitis pigmentosa.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Thailand
Siriraj Hospital
RECRUITING
Bangkok Noi
Contact Information
Primary
Laongsri Atchaneeyasakul, Professor
atchanee@hotmail.com
+66 893138367
Time Frame
Start Date: 2024-05-23
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 15
Treatments
Experimental: Bone marrow-mesenchymal stem cell-derived small extracellular vesicles
Single intravitreal injection of Good Manufacturing Practice (GMP) compliant bone marrow (BM)-mesenchymal stem cell (MSC)-derived small extracellular vesicles (sEVs) (50 μg) for single eye
Related Therapeutic Areas
Sponsors
Leads: Mahidol University