NCT03237442

Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn

Status unknown Phase 1, PHASE2 Last updated 2 August 2017

What this trial tests

Phase 1, PHASE2 trial testing human umbilical cord mesenchymal stem cells in Ocular Corneal Burn in 100 participants. Status unknown.

Timeline

1 January 2018

Primary endpoint
30 December 2018

30 June 2019

Quick facts

Lead sponsor	Guangzhou Saliai Stem Cell Science and Technology Co. Ltd.
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	100
Start date	1 January 2018
Primary completion	30 December 2018
Estimated completion	30 June 2019
Sites	1 location across China

Drugs / interventions tested

• human umbilical cord mesenchymal stem cells
• placebo

Conditions studied

• Ocular Corneal Burn — all drugs for Ocular Corneal Burn →

Sponsor

Guangzhou Saliai Stem Cell Science and Technology Co. Ltd.

Who can join

Adults 18 to 60, any sex, with Ocular Corneal Burn. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Ocular chemical burn is one of the causes of vision loss in China, and there are no satisfactory treatment. Human umbilical cord mesenchymal stem cells(UC-MSCs) have the biological characteristics of self-renewal, immune regulation, multidirectional differentiation and tissue repair. Our preliminary research showed that in corneal alkali injury rabbits, the UC-MSCs can accelerated the cornea repair, inhibited angiogenesis. The aim of this study is to access the efficacy and safety of UC-MSCs in the treatment of corneal burn in human.

Publications & conference data

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

1. Subconjunctival injection of mesenchymal stem cells for corneal failure due to limbal stem cell deficiency: state of the art.
   Galindo S, de la Mata A, López-Paniagua M, Herreras JM, et al · · 2021 · cited 51× · PMID 33441175 · DOI 10.1186/s13287-020-02129-0
2. Therapeutic Properties of Mesenchymal Stem Cell on Organ Ischemia-Reperfusion Injury.
   Oliva J. · · 2019 · cited 34× · PMID 31694240 · DOI 10.3390/ijms20215511
3. Human Umbilical Cord-Derived Mesenchymal Stem Cells Promote Corneal Epithelial Repair In Vitro.
   Kacham S, Bhure TS, Eswaramoorthy SD, Naik G, et al · · 2021 · cited 28× · PMID 34069578 · DOI 10.3390/cells10051254
4. Applications of mesenchymal stem cells in ocular surface diseases: sources and routes of delivery.
   Soleimani M, Masoumi A, Momenaei B, Cheraqpour K, et al · · 2023 · cited 27× · PMID 36719365 · DOI 10.1080/14712598.2023.2175605
5. Goals and Challenges of Stem Cell-Based Therapy for Corneal Blindness Due to Limbal Deficiency.
   Calonge M, Nieto-Miguel T, de la Mata A, Galindo S, et al · · 2021 · cited 24× · PMID 34575560 · DOI 10.3390/pharmaceutics13091483
6. Biomedical Application of MSCs in Corneal Regeneration and Repair.
   De Miguel MP, Cadenas-Martin M, Stokking M, Martin-Gonzalez AI. · · 2025 · cited 7× · PMID 39859409 · DOI 10.3390/ijms26020695
7. The Myofibroblast Fate of Therapeutic Mesenchymal Stromal Cells: Regeneration, Repair, or Despair?
   Younesi FS, Hinz B. · · 2024 · cited 7× · PMID 39201399 · DOI 10.3390/ijms25168712
8. Derivation of Limbal Stem Cells from Human Adult Mesenchymal Stem Cells for the Treatment of Limbal Stem Cell Deficiency.
   Cadenas-Martin M, Arnalich-Montiel F, Miguel MP. · · 2023 · cited 4× · PMID 36768672 · DOI 10.3390/ijms24032350