NCT05413148

The Effect of Stem Cells and Stem Cell Exosomes on Visual Functions in Patients With Retinitis Pigmentosa

Status unknown Phase 2, PHASE3 Last updated 7 September 2022

What this trial tests

Phase 2, PHASE3 trial testing Subtenon injection of Wharton jelly derived mesenchymal stem cells in Retinitis Pigmentosa in 135 participants. Status unknown.

Timeline

5 August 2022

Primary endpoint
1 July 2023

15 December 2023

Quick facts

Lead sponsor	TC Erciyes University
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	135
Start date	5 August 2022
Primary completion	1 July 2023
Estimated completion	15 December 2023
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Subtenon injection of Wharton jelly derived mesenchymal stem cells — full drug profile →
• Subtenon injection of Wharton jelly derived mesenchymal stem cell exosomes — full drug profile →
• Placebo

Conditions studied

• Retinitis Pigmentosa — all drugs for Retinitis Pigmentosa →

Sponsor

TC Erciyes University

Who can join

Adults 18 to 70, any sex, with Retinitis Pigmentosa. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This clinical trial aims to study the efficacy of umbilical cord-derived mesenchymal stem cells and their exosomes in the treatment of retinitis pigmentosa. The participants will be randomized into 3 groups. Functional and structural parameters will be compared before and after the injections and also will be compared among the groups to reveal whether stem cell and their exosomes are more effective than placebo.

Publications & conference data

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

1. Clinical applications of stem cell-derived exosomes.
   Tan F, Li X, Wang Z, Li J, et al · · 2024 · cited 390× · PMID 38212307 · DOI 10.1038/s41392-023-01704-0
2. The potential use of mesenchymal stem cells-derived exosomes as microRNAs delivery systems in different diseases.
   Oveili E, Vafaei S, Bazavar H, Eslami Y, et al · · 2023 · cited 81× · PMID 36690996 · DOI 10.1186/s12964-022-01017-9
3. Extracellular Vesicles as Therapeutic Resources in the Clinical Environment.
   Sanz-Ros J, Mas-Bargues C, Romero-García N, Huete-Acevedo J, et al · · 2023 · cited 53× · PMID 36768664 · DOI 10.3390/ijms24032344
4. Insight into the Functional Dynamics and Challenges of Exosomes in Pharmaceutical Innovation and Precision Medicine.
   Sharma A, Yadav A, Nandy A, Ghatak S. · · 2024 · cited 40× · PMID 38931833 · DOI 10.3390/pharmaceutics16060709
5. The Potential of MSC-Based Cell-Free Therapy in Wound Healing-A Thorough Literature Review.
   Ma H, Siu WS, Leung PC. · · 2023 · cited 39× · PMID 37298306 · DOI 10.3390/ijms24119356
6. Understanding molecular characteristics of extracellular vesicles derived from different types of mesenchymal stem cells for therapeutic translation.
   Ding Z, Greenberg ZF, Serafim MF, Ali S, et al · · 2024 · cited 34× · PMID 38957857 · DOI 10.1016/j.vesic.2024.100034
7. Bone Marrow Mesenchymal Stromal/Stem Cell-Derived Extracellular Vesicles Promote Corneal Wound Repair by Regulating Inflammation and Angiogenesis.
   Saccu G, Menchise V, Gai C, Bertolin M, et al · · 2022 · cited 34× · PMID 36497151 · DOI 10.3390/cells11233892
8. Stem Cell-Based Acellular Therapy: Insight into Biogenesis, Bioengineering and Therapeutic Applications of Exosomes.
   Choudhery MS, Arif T, Mahmood R, Harris DT. · · 2024 · cited 26× · PMID 39062506 · DOI 10.3390/biom14070792