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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

May 23, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Retinitis Pigmentosa
Interventions
BIOLOGICAL

GMP compliant-BM-MSC derived sEVs

The procedure will be performed under topical anesthesia (0.5% tetracaine hydrochloride ophthalmic solution). The intravitreal injection will be performed by the retina specialist. Topical antiseptic (5% povidone iodine solution) will be applied on the periorbital and ocular surface. Eyelid speculum will be inserted to expose the injection area. It will include an intravitreal injection at the superotemporal quadrant (right eye) and superonasal quadrant (left eye), 3.5 to 4 mm posterior to the limbus. A 30-gauge needle will be used to deliver a 0.05 to 0.1 ml sEV suspension into the vitreous cavity. Indirect ophthalmoscopy will be performed immediately after the procedure to ensure no occlusion of the central retinal artery. The eye will be rinsed thoroughly by normal saline to wash out remaining antiseptic. The total duration for an intravitreal injection will be approximately 30 minutes.

Trial Locations (1)

10700

RECRUITING

Siriraj Hospital, Bangkok Noi

All Listed Sponsors
lead

Mahidol University

OTHER