Spheroidal Mesenchymal Stem Cells in Retinitis Pigmentosa
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05712148 |
Recruitment Status :
Completed
First Posted : February 3, 2023
Last Update Posted : February 3, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Purpose: This prospective clinical case series aimed to evaluate the effect of suprachoroidal implantation of mesenchymal stem cells (MSCs) in the form of spheroids as a stem cell therapy for retinitis pigmentosa (RP) patients with relatively good visual acuity.
Methods: Fifteen eyes of 15 patients with RP who received suprachoroidal implantation of MSCs in the form of spheroids were included. Best corrected visual acuity (BCVA), 10-2 and 30-2 visual field examination and multifocal electroretinography (mfERG) recordings were recorded at baseline, postoperative first, third- and sixth-months during follow-up.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Retinitis Pigmentosa Stem Cell Transplant | Biological: Stem cell implantation | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Suprachoroidal Spheroidal Mesenchymal Stem Cell Implantation in Retinitis Pigmentosa: Clinical Results of 6 Months Follow-up |
Actual Study Start Date : | October 11, 2019 |
Actual Primary Completion Date : | January 30, 2022 |
Actual Study Completion Date : | June 14, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Retinitis Pigmentosa patients
Suprachoroidal mesenchymal stem cell implanted Retinitis pigmentosa patients
|
Biological: Stem cell implantation
Suprachoridal mesenchymal spheroidal stem cell implantation |
- Change in visual acuity after stem cell implantation in Retinitis Pigmentosa [ Time Frame: 3 years ]Pre-implantation and post-implantation BCVA was converted to the logarithm of the minimal angle of resolution (logMAR) equivalent.
- Change in microperimetric evaluation after stem cell implantation in Retinitis Pigmentosa [ Time Frame: 3 years ]MD (mean deviation) and PSD (pattern standard deviation) parameters of 10-2 and 30-2 visual field (VF) testing strategies with a Humphrey Field Analyzer model 750I (Carl Zeiss Meditec, Dublin, CA, USA) were obtained.
- Change in electrophysiological testing after stem cell implantation in Retinitis Pigmentosa [ Time Frame: 3 years ]The electrophysiological function was assessed with mfERG evaluation (Monpack 3, Metrovision, France) according to the International Society for Clinical Electrophysiology of Vision (ISCEV) guidelines.After 30 minutes of dark adaptation and pupil dilatation with the application of one drop of tropicamide 1% (Tropamid, Bilim ˙Ilaç, Turkey), phenylephrine 2.5% (Mydfrin, Alcon), and proparacaine hydrochloride 0.5% (Alcaine, Alcon), ERG jet electrodes were placed. Multifocal electroretinographies were recorded after pupil dilatation. The concentric rings were analyzed according to International Society for Clinical Electrophysiology of Vision standards. The amplitude and latencies of P1, N1, and N2 components were recorded for every ring. The mean signal amplitudes (MSAs) of multifocal electroretinography (mfERG) in the macula (central 0°-2°) and the peripheral (2°-5°,5°-10°, 10°-15°, and >15°) signal amplitude changes were evaluated separately.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1) Clinical and genetic diagnosis of Retinitis Pigmentosa
Exclusion Criteria:
- Coexisting ocular pathology that may affect visual acuity, visual field and retinal morphology such as glaucoma, uveitis, previous vitreoretinal surgery,
- Coexisting cataract that may affect mfERG, visual field and/or ocular imaging,
- Refractive error that may affect measurements higher than +6.00D, lower than -6.00D
- Coexisting systemic diseases that may affect visual function such as diabetes, vasculitis, rheumatological diseases and chronic immunosuppressive use,
- Periocular injection of platelet-rich blood and transcorneal electrical stimulation in previous 6 months and 6) previous ocular surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05712148
Turkey | |
Acıbadem University | |
Istanbul, Turkey |
Principal Investigator: | Berna Özkan, Professor | Acibadem University | |
Study Chair: | Ercüment Ovalı, Professor | Acıbadem LabCell Cellular Therapy Center |
Responsible Party: | Berna Özkan, Professor, Acibadem University |
ClinicalTrials.gov Identifier: | NCT05712148 |
Other Study ID Numbers: |
56733164/203 E.3858 |
First Posted: | February 3, 2023 Key Record Dates |
Last Update Posted: | February 3, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Retinitis pigmentosa Mesenchymal stem cells Spheroids Suprachoroidal implantation |
Retinitis Retinitis Pigmentosa Retinal Diseases Eye Diseases |
Eye Diseases, Hereditary Retinal Dystrophies Retinal Degeneration Genetic Diseases, Inborn |