Using stem cells to prevent vision loss in Retinitis Pigmentosa
Role of Umbilical Cord-derived Stem Cell Transplantation and Conditioned Medium to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II
This study is testing whether injecting different amounts of stem cells from umbilical cords can help prevent vision loss in people with Retinitis Pigmentosa.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | PT. Prodia Stem Cell Indonesia Industry-sponsored |
| Locations | 1 site (Yogyakarta, DI Yogyakarta) |
| Trial ID | NCT05909488 on ClinicalTrials.gov |
What this trial studies
This study investigates the transplantation of umbilical cord-derived mesenchymal stem cells (UC-MSC) and conditioned medium (CM) to inhibit vision loss in patients with Retinitis Pigmentosa. Participants will be divided into two groups receiving different dosages of UC-MSC, either 1.5 million or 5 million cells, administered via a peribulbar injection. The study will monitor patients for six months, assessing visual function and potential complications through various eye examinations. The aim is to evaluate the safety and efficacy of this innovative treatment approach.
Who should consider this trial
Good fit: Ideal candidates are individuals with Retinitis Pigmentosa who have a visual acuity better than 20/100 and meet specific electrophysiological criteria.
Not a fit: Patients with other eye diseases, a history of eye tumors, or those undergoing immunosuppressive treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly slow or prevent vision loss in patients with Retinitis Pigmentosa.
How similar studies have performed: While the use of stem cells in ophthalmology is an emerging field, this specific approach has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Visus more than 20/100 * Have more than 0.68 uV on conical receptor cell amplitude checked by ERG * Visual field equivalent diameter more than 10o * Willing to sign informed consent as research subjects * Willing to do the peribulbar injection with mesenchymal stem cells isolated from umbilical cord tissue * Willing to do visual field checks with Humphrey's perimetry, vision tests with Snellen boards, Optical Coherent Tomography (OCT) examinations, electroretinogram examinations, and fill out a quality of life questionnaire Exclusion Criteria: * Pregnant or nursing women * Positive result of HIV test * Have a history of eye tumors * Under immunosuppressive treatment or other drugs that can affect the growth of transplanted stem cells * Have another eye disease such as diabetic retinopathy, uveitis, cataract, and glaucoma * Do not come to control according to the schedule determined by the researcher (loss to follow up)
Where this trial is running
Yogyakarta, DI Yogyakarta
- RSUP Dr. Sardjito — Yogyakarta, DI Yogyakarta, Indonesia (Recruiting)
Study contacts
- Principal investigator: dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD — Gadjah Mada University, Faculty of Medicine
- Study coordinator: dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD
- Email: mb.sasongko@ugm.ac.id
- Phone: +62811293476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.