Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
EARLY_PHASE1
Total Enrollment
44 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-03-01
Study Completion Date
2021-12-30
Brief Summary
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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.
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.
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Detailed Description
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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
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Macular Holes
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Study Groups
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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.
Group Type
EXPERIMENTAL
exosomes derived from mesenchymal stem cells (MSC-Exo)
Intervention Type
BIOLOGICAL
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 .
Control group
Control group that receives treatment of only pars plana vitrectomy(PPV) and ILM peeling.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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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 .
Intervention Type
BIOLOGICAL
Eligibility Criteria
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Inclusion Criteria
1.Clinical diagnosis of idiopathic macular hole whose diameter is greater than 400 microns
Exclusion Criteria
1. Only one functional eye
2. In other clinical trials.
3. Other diseases which can affect visual acuity, such as cataract, diabetic retinopathy, glaucoma, corneal diseases, etc.
4. Eye had undergone vitrectomy or scleral buckling, cataract surgery, Nd:YAG laser less than one month ago.
5. Contralateral eye has poor prognosis than the study eye.
6. Idiopathic or autoimmune uveitis history.
7. Aphakic eye
8. Physical condition is poor that can not keep prone position.
9. Secondary macular lesions
10. 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.
11. Intraocular pressure is higher than 25mmHg
12. Within ocular inflammation, such as eye blepharitis, scleritis, keratitis and conjunctivitis.
13. 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.
2. In other clinical trials.
3. Other diseases which can affect visual acuity, such as cataract, diabetic retinopathy, glaucoma, corneal diseases, etc.
4. Eye had undergone vitrectomy or scleral buckling, cataract surgery, Nd:YAG laser less than one month ago.
5. Contralateral eye has poor prognosis than the study eye.
6. Idiopathic or autoimmune uveitis history.
7. Aphakic eye
8. Physical condition is poor that can not keep prone position.
9. Secondary macular lesions
10. 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.
11. Intraocular pressure is higher than 25mmHg
12. Within ocular inflammation, such as eye blepharitis, scleritis, keratitis and conjunctivitis.
13. 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.
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Tianjin Medical University
OTHER
Sponsor Role
lead
Responsible Party
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Xiaomin Zhang
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Rong X Li, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University Eye Hospital
Locations
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Tianjin Medical University Hospital
Tianjin, , China
Site Status
Countries
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China
References
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Other Identifiers
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2015KY-05
Identifier Type: -
Identifier Source: org_study_id
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