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

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

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-07

Study Completion Date

2019-09-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Retinitis Pigmentosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Conditioned Medium (CM)

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

Group Type ACTIVE_COMPARATOR

Conditioned Medium (CM)

Intervention Type BIOLOGICAL

Conditioned Medium (CM) injected by peribulbar

UC-MSC + NaCl

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

Group Type ACTIVE_COMPARATOR

Umbilical Cord Mesenchymal Stem Cell (UC-MSC)

Intervention Type BIOLOGICAL

Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar

UC-MSC+CM

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

Group Type ACTIVE_COMPARATOR

Umbilical Cord Mesenchymal Stem Cell (UC-MSC)

Intervention Type BIOLOGICAL

Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar

Conditioned Medium (CM)

Intervention Type BIOLOGICAL

Conditioned Medium (CM) injected by peribulbar

Interventions

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Umbilical Cord Mesenchymal Stem Cell (UC-MSC)

Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar

Intervention Type BIOLOGICAL

Conditioned Medium (CM)

Conditioned Medium (CM) injected by peribulbar

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No