NCT06242379RecruitingPhase 1/2
Safety and Efficacy of Stem Cell Small Extracellular Vesicles in Patients With Retinitis Pigmentosa
Safety and Efficacy Evaluation of Intravitreal Injection of GMP-compliant Bone Marrow Mesenchymal Stem Cell-derived Small Extracellular Vesicles in Patients With Retinitis Pigmentosa
Source: ClinicalTrials.gov · Last updated 15 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 12 Jan 2024
- Start date
- 23 May 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Mahidol University
- Diseases
- Retinitis pigmentosa
- NCT number
- NCT06242379
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 15
- From 23 May 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Inherited or acquired bleeding disorders, including the use of anticoagulant medications that cannot be stopped prior the procedure
- Autoimmune diseases, i.e., systemic lupus erythematosus, multiple sclerosis, fibromyalgia, Guillain-Barre syndrome
- Severe/uncontrolled chronic/metabolic diseases, e.g., diabetes mellitus, cardiovascular disease, chronic kidney disease, transient ischemic attack (TIA)/stroke
Other illness
- Having blood-borne infections, i.e. Human immunodeficiency virus (HIV), hepatitis B or C, Human T-lymphotropic viruses (HTLV)
Other
- Intolerance and/or contraindication to local anesthesia and other substances used during the procedure
- Pregnant or lactating woman
- Unable to complete the full course of the study or failed to return for follow up
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Siriraj Hospital Coordinator of this site? Confirm its status | Bangkok Noi | Thailand | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.