NCT06242379 Safety and Efficacy of Stem Cell Small Extracellular Vesicles in Patients With Retinitis Pigmentosa
| NCT ID | NCT06242379 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Mahidol University |
| Condition | Retinitis Pigmentosa |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-05-23 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2024-05-23 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Laongsri Atchaneeyasakul, Professor
PRINCIPAL INVESTIGATOR
Mahidol University
Frequently Asked Questions
Who can join the NCT06242379 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Retinitis Pigmentosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06242379 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06242379 currently recruiting?
Yes, NCT06242379 is actively recruiting participants. Contact the research team at atchanee@hotmail.com for enrollment information.
Where is the NCT06242379 trial being conducted?
This trial is being conducted at Bangkok Noi, Thailand.
Who is sponsoring the NCT06242379 clinical trial?
NCT06242379 is sponsored by Mahidol University. The principal investigator is Laongsri Atchaneeyasakul, Professor at Mahidol University. The trial plans to enroll 15 participants.