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Spheroidal Mesenchymal Stem Cells in Retinitis Pigmentosa

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ClinicalTrials.gov Identifier: NCT05712148
Recruitment Status : Completed
First Posted : February 3, 2023
Last Update Posted : February 3, 2023
Sponsor:
Information provided by (Responsible Party):
Berna Özkan, Acibadem University

Brief Summary:

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

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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

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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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1) Clinical and genetic diagnosis of Retinitis Pigmentosa

Exclusion Criteria:

  1. Coexisting ocular pathology that may affect visual acuity, visual field and retinal morphology such as glaucoma, uveitis, previous vitreoretinal surgery,
  2. Coexisting cataract that may affect mfERG, visual field and/or ocular imaging,
  3. Refractive error that may affect measurements higher than +6.00D, lower than -6.00D
  4. Coexisting systemic diseases that may affect visual function such as diabetes, vasculitis, rheumatological diseases and chronic immunosuppressive use,
  5. Periocular injection of platelet-rich blood and transcorneal electrical stimulation in previous 6 months and 6) previous ocular surgery

Information from the National Library of Medicine

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


Locations
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Turkey
Acıbadem University
Istanbul, Turkey
Sponsors and Collaborators
Acibadem University
Investigators
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Principal Investigator: Berna Özkan, Professor Acibadem University
Study Chair: Ercüment Ovalı, Professor Acıbadem LabCell Cellular Therapy Center
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Berna Özkan, Acibadem University:
Retinitis pigmentosa
Mesenchymal stem cells
Spheroids
Suprachoroidal implantation
Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn