Safety Issues of Peribulbar Injection of UC-MSC in Patients With Retinitis Pigmentosa (RP)

PT. Prodia Stem Cell Indonesia

Status and phase: Completed; Phase 2; Phase 1

Conditions: Retinitis Pigmentosa

Treatments: Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC); Biological: Conditioned Medium (CM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04315025

CT/RP/02/2018

Details and patient eligibility

About

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 consists of 6 subjects. all groups will be transplanted via peribulbar route. the dosage of UC-MSC is 1 million cells for each subject. All groups will be observed until 6 months.

Full 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 except for the eyes. 1.8 ml cell preparations are suspended in physiological NaCl until it reaches a total of 2 ml volume of cell suspension (for UC-MSC + NaCl group). Stem cell suspension will be injected by peribulbar and if the injection was done, patients will be given a quinolone antibiotic. On day 1st and day 7th after therapy, patients will be observed the presence of infection, inflammation, and increasing of eye pressure. On day 7th, day 30th, and day 90th after therapy, patients will do a visual field test, visual acuity test, electroretinography, funduscopy, and Optical Coherence Tomography examination. The observation results will be written in the observation table and analyzed by a statistic. After the data was completed, then make a discussion, conclusion, and suggestion of the study.

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 3 patient groups

Conditioned Medium (CM)

Active Comparator group

Description:

a total 2 ml volume of Conditioned Medium derived Umbilical Cord Mesenchymal Stem Cell will be injected by peribulbar

Treatment:

Biological: Conditioned Medium (CM)

UC-MSC + NaCl

Active Comparator group

Description:

1.8 ml cell preparations are suspended in physiological NaCl until it reaches a total of 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) suspension will be injected by peribulbar

Treatment:

Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)

UC-MSC+CM

Active Comparator group

Description:

1.8 ml cell preparations are suspended in Conditioned Medium (CM) until it reaches total of 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) + Conditioned Medium (CM) suspension will be injected by peribulbar

Treatment:

Biological: Conditioned Medium (CM)

Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)