Retinitis Pigmentosa Clinical Trial
— WJ-MSCOfficial title:
Management of Retinitis Pigmentosa by Wharton's Jelly Derived Mesenchymal Stem Cells: Preliminary Clinical Results
Verified date | January 2020 |
Source | Ankara Universitesi Teknokent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to determine if umbilical cord Wharton's jelly derived mesenchymal stem cells implanted in sub-tenon space have beneficial effects on visual functions in retinitis pigmentosa patients by reactivating the degenerated photoreceptors in dormant phase.
Status | Completed |
Enrollment | 32 |
Est. completion date | January 1, 2020 |
Est. primary completion date | October 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - • 18 years of age or older; - Diagnosis of any phenotypic or genotypic variation of RP, confirmed by clinical history, fundus appearance, visual field (VF), electroretinogram (ERG) and genetic mutation analysis; - Having experienced various degrees of VF loss; - BCVA from 50 letters to 110 letters in the ETDRS chart testing (Topcon CC-100 XP, Japan); - Mean deviation (MD) values ranging between -33.0 and -5.0 dB with Compass visual field analysis (threshold 24-2, Sita Standard, Stimulus 3-white); - Intraocular pressure (IOP) of <22 mmHg. Exclusion Criteria: - • The presence of cataracts or other media opacity that might affect the VF, MD, or ERG recordings; - The presence of glaucoma, which causes visual field and optic disc changes; - The presence of any systemic disorder (e.g.,diabetes, neurological disease, or uncontrolled systemic hypertension) that may affect visual function; - The habit of smoking. |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara University Biotechnology Institute | Ankara | Türkiye |
Turkey | Umut Arslan | Ankara | Türkiye |
Lead Sponsor | Collaborator |
---|---|
Ankara Universitesi Teknokent |
Turkey,
Canto-Soler V, Flores-Bellver M, Vergara MN. Stem Cell Sources and Their Potential for the Treatment of Retinal Degenerations. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(5):ORSFd1-9. doi: 10.1167/iovs.16-19127. Review. — View Citation
Garg A, Yang J, Lee W, Tsang SH. Stem Cell Therapies in Retinal Disorders. Cells. 2017 Feb 2;6(1). pii: E4. doi: 10.3390/cells6010004. Review. — View Citation
Leow SN, Luu CD, Hairul Nizam MH, Mok PL, Ruhaslizan R, Wong HS, Wan Abdul Halim WH, Ng MH, Ruszymah BH, Chowdhury SR, Bastion ML, Then KY. Safety and Efficacy of Human Wharton's Jelly-Derived Mesenchymal Stem Cells Therapy for Retinal Degeneration. PLoS — View Citation
Limoli PG, Vingolo EM, Limoli C, Scalinci SZ, Nebbioso M. Regenerative Therapy by Suprachoroidal Cell Autograft in Dry Age-related Macular Degeneration: Preliminary In Vivo Report. J Vis Exp. 2018 Feb 12;(132). doi: 10.3791/56469. — View Citation
Mohamed EM, Abdelrahman SA, Hussein S, Shalaby SM, Mosaad H, Awad AM. Effect of human umbilical cord blood mesenchymal stem cells administered by intravenous or intravitreal routes on cryo-induced retinal injury. IUBMB Life. 2017 Mar;69(3):188-201. doi: 1 — View Citation
Musial-Wysocka A, Kot M, Sulkowski M, Badyra B, Majka M. Molecular and Functional Verification of Wharton's Jelly Mesenchymal Stem Cells (WJ-MSCs) Pluripotency. Int J Mol Sci. 2019 Apr 12;20(8). pii: E1807. doi: 10.3390/ijms20081807. — View Citation
Rani S, Ryan AE, Griffin MD, Ritter T. Mesenchymal Stem Cell-derived Extracellular Vesicles: Toward Cell-free Therapeutic Applications. Mol Ther. 2015 May;23(5):812-823. doi: 10.1038/mt.2015.44. Epub 2015 Mar 19. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ETDRS visual acuity | The visual acuity scores obtained from the baseline testing and the final examination were analyzed and compared statistically to determine effectiveness. | Change from baseline visual acuity at 6 months | |
Secondary | Outer retinal thickness | This is the thickness from the outer plexiform layer to the Bruch membrane in the 3x3 mm area of the fovea measured (and recorded automatically) by the multimodal imaging OCTA device. | Change from baseline outer retinal thickness at 6 months |
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