The study will perform UC-MSCs and CM transplantation. There are two groups with different dosages. The first group will be transplanted with 1.5 million cells, meanwhile, the second group is 5 million cells. Each group consists of 30 subjects. All groups will be transplanted via the peribulbar route. All groups will be observed until six months.
Visus more than 20/100
Have more than 0.68 uV on conical receptor cell amplitude checked by ERG
Visual field equivalent diameter more than 10o
Willing to sign informed consent as research subjects
Pregnant or nursing women
Positive result of HIV test
Have a history of eye tumors
Under immunosuppressive treatment or other drugs that can affect the growth of transplanted stem cells
Parallel
1.5 x 10^6 UC-MSC + CM
Biological/Vaccine1.5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)
5 x 10^6 UC-MSC + CM
Biological/Vaccine5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)
Incident of Adverse Events
assessment of infection, inflammation, eye pressure and patients complaints
Incident of Adverse Events
assessment of infection, inflammation, eye pressure and patients complaints
Frequency of Adverse Events
assessment of infection, inflammation, eye pressure and patients complaints
Frequency of Adverse Events
assessment of infection, inflammation, eye pressure and patients complaints
Patients Quality of Life
Patient's quality of life using National Eye Institute-Visual Functional Questioner 25
Patients Quality of Life
Patient's quality of life using National Eye Institute-Visual Functional Questioner 25
Patients Quality of Life
Patient's quality of life using National Eye Institute-Visual Functional Questioner 25
Patients Quality of Life
Patient's quality of life using National Eye Institute-Visual Functional Questioner 25
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This trial is not recruiting at the moment. You can still explore other options:
