Status:
UNKNOWN
MSC-Exos Promote Healing of MHs
Lead Sponsor:
Tianjin Medical University
Conditions:
Macular Holes
Eligibility:
All Genders
Up to 80 years
Phase:
EARLY_PHASE1
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 ...
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 hea...
Eligibility Criteria
Inclusion
- Clinical diagnosis of idiopathic macular hole whose diameter is greater than 400 microns
Exclusion
- 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.
- Intraocular pressure is higher than 25mmHg
- Within ocular inflammation, such as eye blepharitis, scleritis, keratitis and conjunctivitis.
- Systemic condition is poor, such as the poor control of diabetes and hypertension, myocardial infarction, cerebrovascular accident, renal failure and so on,and the researchers assessed those who are unable to complete the trail.
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03437759
Start Date
March 1 2017
End Date
December 30 2021
Last Update
April 6 2021
Active Locations (1)
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1
Tianjin Medical University Hospital
Tianjin, China