An Early Phase 1 interventional study of exosomes derived from mesenchymal stem cells (MSC-Exo) in Macular Holes, sponsored by Tianjin Medical University. Status unknown at 1 site in China. Open to participants aged Up to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-06.
Sponsored by Tianjin Medical University · Early Phase 1, Interventional, and Treatment
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.
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.
1.Clinical diagnosis of idiopathic macular hole whose diameter is greater than 400 microns
Exclusion Criteria:
Our intervention is to add treatment of exosomes derived from mesenchymal stem cells (MSC-Exo) after pars plana vitrectomy(PPV) and ILM peeling.
Biological: exosomes derived from mesenchymal stem cells (MSC-Exo)
Control group that receives treatment of only pars plana vitrectomy(PPV) and ILM peeling.
After air-liquid exchange, 50μg or 20μg MSC-Exo in 10μl PBS was dripped into vitreous cavity around MH, leaving 20% SF6 or air as tamponade .
Macular holes closure
Minimum linear diameter (MLD) of the hole measured by OCT
Time frame: baseline to 24 weeks post-surgery
Best corrected visual acuity(BCVA)
BCVA using a Landolt C acuity chart method
Time frame: baseline to 24 weeks post-surgery
Plan to share: No
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Tianjin Medical University