NCT05712148

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
Last Updated

February 3, 2023

Status Verified

January 1, 2023

Enrollment Period

2.3 years

First QC Date

January 16, 2023

Last Update Submit

January 25, 2023

Conditions

Retinitis PigmentosaStem Cell Transplant

Keywords

Retinitis pigmentosaMesenchymal stem cellsSpheroidsSuprachoroidal implantation

Outcome Measures

Primary Outcomes (3)

  • Change in visual acuity after stem cell implantation in Retinitis Pigmentosa

    Pre-implantation and post-implantation BCVA was converted to the logarithm of the minimal angle of resolution (logMAR) equivalent.

    3 years

  • Change in microperimetric evaluation after stem cell implantation in Retinitis Pigmentosa

    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 years

  • Change in electrophysiological testing after stem cell implantation in Retinitis Pigmentosa

    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.

    3 years

Study Arms (1)

Retinitis Pigmentosa patients

EXPERIMENTAL

Suprachoroidal mesenchymal stem cell implanted Retinitis pigmentosa patients

Biological: Stem cell implantation

Interventions

Stem cell implantationBIOLOGICAL

Suprachoridal mesenchymal spheroidal stem cell implantation

Retinitis Pigmentosa patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \) Clinical and genetic diagnosis of Retinitis Pigmentosa

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Berna Özkan, Professor

    Acibadem University

    PRINCIPAL INVESTIGATOR

  • Ercüment Ovalı, Professor

    Acıbadem LabCell Cellular Therapy Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 16, 2023

First Posted

February 3, 2023

Study Start

October 11, 2019

Primary Completion

January 30, 2022

Study Completion

June 14, 2022

Last Updated

February 3, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)