Trials / Unknown
UnknownNCT03437759
MSC-Exos Promote Healing of MHs
Mesenchymal Stem Cells Derived Exosomes Promote Healing of Large and Refractory Macular Holes
- Status
- Unknown
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- Sponsor
- Tianjin Medical University · Academic / Other
- Sex
- All
- Age
- 80 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 . |
Timeline
- Start date
- 2017-03-01
- Primary completion
- 2018-05-30
- Completion
- 2021-12-30
- First posted
- 2018-02-19
- Last updated
- 2021-04-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03437759. Inclusion in this directory is not an endorsement.