Actively Recruiting
Safety and Efficacy of Stem Cell Small Extracellular Vesicles in Patients With Retinitis Pigmentosa
Led by Mahidol University · Updated on 2025-05-15
15
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Stem Cell Small Extracellular Vesicles in Patients With Retinitis Pigmentosa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or above
- Clinically diagnosed with retinitis pigmentosa by experienced ophthalmologists or confirmed gene mutations causing RP
- Central visual field in the better eye is 20 degrees or less
- Best corrected visual acuity in the worse eye between 6/18 (logMAR 0.48) and 6/120 (logMAR 1.3) using Snellen chart
- Electroretinogram in the worse eye is nonrecordable or less than 25% of normal amplitude
- Willing and able to provide informed consent to participate
You will not qualify if you...
- Intolerance or contraindication to local anesthesia or substances used during the procedure
- Pregnant or lactating women
- Presence of blood-borne infections such as HIV, hepatitis B or C, or HTLV
- Significant ocular or other diseases that pose risk or affect study participation or results, including:
- Bleeding disorders or use of anticoagulants that cannot be stopped before procedure
- Autoimmune diseases like lupus, multiple sclerosis, fibromyalgia, Guillain-Barre syndrome
- Severe or uncontrolled chronic or metabolic diseases such as diabetes, cardiovascular disease, chronic kidney disease, or recent stroke/TIA
- Inability to complete the full study or attend follow-up visits
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Siriraj Hospital
Bangkok Noi, Bangkok, Thailand, 10700
Actively Recruiting
Research Team
L
Laongsri Atchaneeyasakul, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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