MSC-Exos Promote Healing of MHs (MSCs)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03437759|
Recruitment Status : Active, not recruiting
First Posted : February 19, 2018
Last Update Posted : April 6, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Macular Holes||Biological: exosomes derived from mesenchymal stem cells (MSC-Exo)||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Mesenchymal Stem Cells Derived Exosomes Promote Healing of Large and Refractory Macular Holes|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||May 30, 2018|
|Estimated Study Completion Date :||December 30, 2021|
Experimental: Experimental group
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)
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 .
No Intervention: Control group
Control group that receives treatment of only pars plana vitrectomy(PPV) and ILM peeling.
- Macular holes closure [ Time Frame: baseline to 24 weeks post-surgery ]Minimum linear diameter (MLD) of the hole measured by OCT
- Best corrected visual acuity(BCVA) [ Time Frame: baseline to 24 weeks post-surgery ]BCVA using a Landolt C acuity chart method
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437759
|Tianjin Medical University Hospital|
|Principal Investigator:||Rong X Li, MD,PhD||Tianjin Medical University Eye Hospital|