Status:
COMPLETED
Safety Issues of Peribulbar Injection of UC-MSC in Patients With Retinitis Pigmentosa
Lead Sponsor:
PT. Prodia Stem Cell Indonesia
Conditions:
Retinitis Pigmentosa
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The study will perform UC-MSCs and CM transplantation. The first group will be injected by UCMSC+NaCl. the 2nd group will be injected by UC-MSC+CM. the 3rd group will be injected by CM. Each group con...
Detailed Description
The eyes which will give the transplant should be given an aseptic and antiseptic technique to prevent the contamination from the inside and outside. Sterile cover attached to other parts of the face ...
Eligibility Criteria
Inclusion
- Visual field defects at initial examination with Humhprey perimetry are between 25% to 50%
- Willing to sign informed consent as research subjects
- Willing to do peribulbar injection with mesenchymal stem cells isolated from umbilical cord tissue
- Willing to do visual field checks with Humphrey's perimetry, vision tests with Snellen boards, Optical Coherrent Tomography (OCT) examinations, electroretinogram examinations and fill out a quality of life questionnaire
Exclusion
- Pregnant or nursing women
- Positive result of HIV test
- Have a history of eye tumors
- In immunosuppressive treatment or other drugs that can affect the growth of transplanted stem cells
- Have another eye disease such as diabetic retinopathy, uveitis, cataract, and glaucoma
- Do not come to control according to the schedule determined by the researcher (loss to follow up)
Key Trial Info
Start Date :
October 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04315025
Start Date
October 7 2018
End Date
September 20 2019
Last Update
June 4 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Jakarta Eye Center Hospital
Jakarta, DKI Jakarta, Indonesia
2
Sardjito Hospital
Yogyakarta, Special Region, Indonesia, 55284