MSC-Exos Promote Healing of MHs — MSCs  

Macular Holes Clinical Trial

Official title: Mesenchymal Stem Cells Derived Exosomes Promote Healing of Large and Refractory Macular Holes

Status Active, not recruiting

Clinical Trial Summary

Purpose: To assess the safety and efficacy of mesenchymal stem cells (MSCs) and MSC-derived exosomes (MSC-Exos) for promoting healing of large and refractory macular holes (MHs).

Hypothesis: MSC and MSC-Exo therapy may promote functional and anatomic recovery from MH. MSC-Exo therapy may be a useful and safe method for improving visual outcomes of surgery for refractory MHs.

Clinical Trial Description

Based on the purpose and hypothesis,the participants with large and longstanding idiopathic MHs underwent vitrectomy, internal limiting membrane peeling, MSC or MSC-Exo intravitreal injection, and heavy silicon oil, air, 20% SF6, or 14% C3F8 tamponade. MSCs were isolated from human umbilical cord, and MSC-Exos were isolated from supernatants of MSCs via sequential ultracentrifugation. At the time of study enrollment, as well as physical examinations, best-corrected visual acuity (BCVA) and intraocular pressure will be measured and fundoscopy be performed. All diagnoses of MH are going to confirmed via spectral-domain optical coherence tomography (OCT), and the minimum linear diameter (MLD) of each MH will be measured parallel to the retinal pigment epithelium.The participants are going to be followed up for at least 6 months via BCVA measurement, fundoscopy, OCT, and physical examinations. ;

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

• NCT number: NCT03437759
• Study type: Interventional
• Source: Tianjin Medical University
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: March 1, 2017
• Completion date: December 30, 2021