Using stem cell-derived vesicles to treat retinitis pigmentosa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of intravitreal injections of small extracellular vesicles derived from bone marrow mesenchymal stem cells in patients with retinitis pigmentosa. The study builds on previous research that indicated potential benefits from stem cell treatments for inherited retinal diseases. Participants will be monitored for safety and visual acuity improvements following the treatment. The trial aims to minimize adverse effects while maintaining therapeutic benefits through a cell-free approach.

Why it matters

Who can join: the full rules

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

Where it's running

• Siriraj Hospital
  Bangkok Noi, Bangkok, Thailand Recruiting

Study contacts

• Principal investigator: Laongsri Atchaneeyasakul, Professor — Mahidol University
• Study coordinator: Laongsri Atchaneeyasakul, Professor
• Email: atchanee@hotmail.com
• Phone: +66 893138367

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• OCT-980 oral treatment for rhodopsin-associated autosomal dominant retinitis pigmentosa

  This program will test whether the oral drug OCT-980 is safe, well tolerated, and shows signs of benefit in adults with RHO-associated autosomal dominant retinitis pigmentosa and in healthy volunteers.

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• Course of EYS-associated retinitis pigmentosa in adults from Russia and former CIS

  We will follow adults with pathogenic EYS gene variants from Russia and former CIS for four years to try to find reliable vision and retinal measures for future treatments.

  Recruiting Sensor Technology for Deafblind · Moscow · NCT07228793

• ZVS203e eye gene-editing therapy for a specific RHO-related retinitis pigmentosa

  This trial tests a single subretinal injection of ZVS203e to see if it’s safe and can help a specific RP caused by an RHO mutation.

  Recruiting Phase 1/2 Chigenovo Co., Ltd · Beijing, Beijing Municipality · NCT06952842

• Testing IGT001 for treating Retinitis Pigmentosa

  This study is testing a new treatment called IGT001 for people with retinitis pigmentosa to see if it can help improve their vision and how safe it is to use.

  Recruiting Phase 1 Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Shanghai · NCT06936787

• Safety of a one-time DSP-3077 retinal sheet injection in adults with retinitis pigmentosa

  This will test whether a single subretinal injection of DSP-3077 retinal sheets is safe and well tolerated in adults with retinitis pigmentosa.

  Recruiting at 2 sites Phase 1/2 Sumitomo Pharma America, Inc. · Boston, Massachusetts and 1 other locations · NCT06891885

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.