Back to resultsMSC-Exos Promote Healing of MHs (MSCs)
Primary Purpose
Macular Holes
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
exosomes derived from mesenchymal stem cells (MSC-Exo)
Sponsored by
About this trial
This is an interventional treatment trial for Macular Holes focused on measuring macular hole (MH), exosomes, mesenchymal stem cells, pars plana vitrectomy
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.
- 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.
Sites / Locations
- Tianjin Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
Our intervention is to add treatment of exosomes derived from mesenchymal stem cells (MSC-Exo) after pars plana vitrectomy(PPV) and ILM peeling.
Control group that receives treatment of only pars plana vitrectomy(PPV) and ILM peeling.
Outcomes
Primary Outcome Measures
Macular holes closure
Minimum linear diameter (MLD) of the hole measured by OCT
Secondary Outcome Measures
Best corrected visual acuity(BCVA)
BCVA using a Landolt C acuity chart method
Full Information
NCT ID
NCT03437759
First Posted
January 23, 2018
Last Updated
April 1, 2021
Sponsor
Tianjin Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03437759
Brief Title
MSC-Exos Promote Healing of MHs
Acronym
MSCs
Official Title
Mesenchymal Stem Cells Derived Exosomes Promote Healing of Large and Refractory Macular Holes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Holes
Keywords
macular hole (MH), exosomes, mesenchymal stem cells, pars plana vitrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Our intervention is to add treatment of exosomes derived from mesenchymal stem cells (MSC-Exo) after pars plana vitrectomy(PPV) and ILM peeling.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group that receives treatment of only pars plana vitrectomy(PPV) and ILM peeling.
Intervention Type
Biological
Intervention Name(s)
exosomes derived from mesenchymal stem cells (MSC-Exo)
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Macular holes closure
Description
Minimum linear diameter (MLD) of the hole measured by OCT
Time Frame
baseline to 24 weeks post-surgery
Secondary Outcome Measure Information:
Title
Best corrected visual acuity(BCVA)
Description
BCVA using a Landolt C acuity chart method
Time Frame
baseline to 24 weeks post-surgery
10. Eligibility
Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rong X Li, MD,PhD
Organizational Affiliation
Tianjin Medical University Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Hospital
City
Tianjin
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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MSC-Exos Promote Healing of MHs
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