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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03437759
Other study ID # 2015KY-05
Secondary ID
Status Active, not recruiting
Phase Early Phase 1
First received
Last updated
Start date March 1, 2017
Est. completion date December 30, 2021

Study information

Verified date April 2021
Source Tianjin Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


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Study Design


Related Conditions & MeSH terms


Intervention

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 .

Locations

Country Name City State
China Tianjin Medical University Hospital Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Tianjin Medical University

Country where clinical trial is conducted

China, 

References & Publications (38)

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Outcome

Type Measure Description Time frame Safety issue
Primary Macular holes closure Minimum linear diameter (MLD) of the hole measured by OCT baseline to 24 weeks post-surgery
Secondary Best corrected visual acuity(BCVA) BCVA using a Landolt C acuity chart method baseline to 24 weeks post-surgery
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