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Tests treatment safety and results for Retinitis Pigmentosa
Official title Safety and Efficacy of Stem Cell Small Extracellular Vesicles in Patients With Retinitis Pigmentosa
ClinicalTrials.gov ID: NCT06242379
What this study is testing
What is GMP compliant-BM-MSC derived sEVs?
GMP compliant-BM-MSC derived sEVs is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for retinitis pigmentosa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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 people at risk because of participation in the study, or...
- 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
See the full eligibility 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
- 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 people at risk because of participation in the study, or may influence the results of the study, or the people ability to...
- 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
- Unable to complete the full course of the study or failed to return for follow up
The study team makes the final eligibility decision.
Where it's taking place
- Bangkok Noi, Bangkok, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bangkok Noi, Bangkok, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.