Mesenchymal Stem Cells Derived Exosomes Promote Healing of Large and Refractory Macular Holes
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Macular Holes
- Sponsor
- Tianjin Medical University
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Macular holes closure
- Last Updated
- 5 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Xiaomin Zhang
Principal Investigator
Tianjin Medical University Eye Hospital
Eligibility Criteria
Inclusion Criteria
- •1.Clinical diagnosis of idiopathic macular hole whose diameter is greater than 400 microns
Exclusion Criteria
- •Only one functional eye
- •In other clinical trials.
- •Other diseases which can affect visual acuity, such as cataract, diabetic retinopathy, glaucoma, corneal diseases, etc.
- •Eye had undergone vitrectomy or scleral buckling, cataract surgery, Nd:YAG laser less than one month ago.
- •Contralateral eye has poor prognosis than the study eye.
- •Idiopathic or autoimmune uveitis history.
- •Aphakic eye
- •Physical condition is poor that can not keep prone position.
- •Secondary macular lesions
- •The equivalent spherical diopter of the study eye before any refractive correction or cataract surgery, which is greater than 6.0d or above 26mm of the ocular axis of the study eye.
Outcomes
Primary Outcomes
Macular holes closure
Time Frame: baseline to 24 weeks post-surgery
Minimum linear diameter (MLD) of the hole measured by OCT
Secondary Outcomes
- Best corrected visual acuity(BCVA)(baseline to 24 weeks post-surgery)