NCT05800301

Management of Retinitis Pigmentosa Via Combination of Wharton's Jelly-derived Mesenchymal Stem Cells and Magnovision

Completed Phase 3 Last updated 5 April 2023

What this trial tests

Phase 3 trial testing Wharton's jelly derived mesenchymal stemcells in Retinitis Pigmentosa in 80 participants. Completed in 31 December 2022.

Timeline

1 January 2019

Primary endpoint
31 December 2021

31 December 2022

Quick facts

Lead sponsor	Ankara Universitesi Teknokent
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	80
Start date	1 January 2019
Primary completion	31 December 2021
Estimated completion	31 December 2022
Sites	3 locations across Turkey (Türkiye)

Drugs / interventions tested

• Wharton's jelly derived mesenchymal stemcells — full drug profile →
• Magnovision

Conditions studied

• Retinitis Pigmentosa — all drugs for Retinitis Pigmentosa →

Sponsor

Ankara Universitesi Teknokent — full company profile →

Who can join

18 and older, any sex, with Retinitis Pigmentosa. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Purpose To investigate whether the natural progression rate of retinitis pigmentosa (RP) can be decreased with subtenon umbilical cord Wharton's jelly derived mesenchymal stemcell (WJ-MSC) application alone or combination with retinal electromagnetic stimulation (rEMS).

Material and methods The study included prospective analysis of 130 eyes of 80 retinitis pigmentosa patients with a 36-month follow-up duration. Patients constitute 4 groups with similar demographic characteristics. The subtenon WJ-MSC only group consisted of 34 eyes of 32 RP patients as Group1; The rEMS only group consisted of 32 eyes of 16 RP patients as Group2; The combined management group consisted of 32 eyes of 16 RP patients who received combined WJ-MSC and rEMS as Group3; The natural course (control) group consisted of 32 eyes of 16 RP patients who did not receive any treatment were classified as Group4. Fundus autofluorescence surface area (FAF-field), horizontal and vertical ellipsoid zone width (EZW), fundus perimetry deviation index (FPDI), full field electroretinography magnitude (ERG-m) and best corrected visual acuity (BCVA) changes were compared within and between groups after 36 month follow up period.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Induced Pluripotent (iPSC) and Mesenchymal (MSC) Stem Cells for In Vitro Disease Modeling and Regenerative Medicine.
   Panferov E, Dodina M, Reshetnikov V, Ryapolova A, et al · · 2025 · cited 8× · PMID 40565081 · DOI 10.3390/ijms26125617
2. Management of Retinitis Pigmentosa Via Wharton's Jelly-Derived Mesenchymal Stem Cells or Combination With Magnovision: 3-Year Prospective Results.
   Ozmert E, Arslan U. · · 2023 · cited 8× · PMID 37713598 · DOI 10.1093/stcltm/szad051
3. Evaluation of mesenchymal stem cells as an <i>in vitro</i> model for inherited retinal diseases.
   Dodina M, Gurtsieva D, Karabelsky A, Minskaia E. · · 2024 · cited 2× · PMID 39620144 · DOI 10.3389/fcell.2024.1455140
4. Therapeutic potential of mesenchymal stem cells in ocular degenerative disorders.
   Xiang Y, Zuo G, He X, Wang K, et al · · 2026 · PMID 41736120 · DOI 10.1186/s12967-026-07878-9
5. Decoding retinitis pigmentosa: molecular targets and therapy with focus on pre-mRNA splicing.
   Banik P, Staněk D. · · 2025 · PMID 41315142 · DOI 10.1007/s00018-025-05987-0