Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06242379

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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:
  1. Bleeding disorders or use of anticoagulants that cannot be stopped before procedure
  2. Autoimmune diseases like lupus, multiple sclerosis, fibromyalgia, Guillain-Barre syndrome
  3. 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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Siriraj Hospital

Bangkok Noi, Bangkok, Thailand, 10700

Actively Recruiting

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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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