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Completed

NCT Number: NCT04315025

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

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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Key information

Conditions

Retinitis Pigmentosa Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Retinal Degeneration Retinal Diseases Retinal Dystrophies

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Jakarta Eye Center Hospital, Jakarta, DKI Jakarta, Indonesia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Umbilical Cord Mesenchymal Stem Cell (UC-MSC)

Biological

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

Conditioned Medium (CM)

Biological

Conditioned Medium (CM) injected by peribulbar

Primary outcomes

  1. Visual Acuity Test

    Time frame: 1 week after injection

    a test to see the sharpness of vision using Snellen Chart which is read at a distance of 6 meters. Normal eye test results are stated in 6/6.

  2. Visual Acuity Test

    Time frame: 1 month after injection

    a test to see the sharpness of vision using Snellen Chart which is read at a distance of 6 meters. Normal eye test results are stated in 6/6.

  3. Visual Acuity Test

    Time frame: 3 months after injection

    a test to see the sharpness of vision using Snellen Chart which is read at a distance of 6 meters. Normal eye test results are stated in 6/6.

  4. Visual Field Test

    Time frame: 1 week after injection

    a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humprey's perimetry.

  5. Visual Field Test

    Time frame: 1 month after injection

    a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humprey's perimetry.

  6. Visual Field Test

    Time frame: 3 months after injection

    a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humprey's perimetry.

  7. Funduscopy

    Time frame: 1 week after injection

    an examination to see and assess the abnormalities and conditions in the ocular fundus using an ophthalmoscope. This examination is carried out by an ophthalmologist.

  8. Funduscopy

    Time frame: 1 month after injection

    an examination to see and assess the abnormalities and conditions in the ocular fundus using an ophthalmoscope. This examination is carried out by an ophthalmologist.

  9. Funduscopy

    Time frame: 3 months after injection

    an examination to see and assess the abnormalities and conditions in the ocular fundus using an ophthalmoscope. This examination is carried out by an ophthalmologist.

  10. Electrorectinography

    Time frame: 1 week after injection

    an examination to provide a picture of objectivity, a quantitative measure of retinal function to monitor the function of stem cells and ganglion cells in the eye. This examination is carried out by a trained ophthalmologist.

  11. Electrorectinography

    Time frame: 1 month after injection

    an examination to provide a picture of objectivity, a quantitative measure of retinal function to monitor the function of stem cells and ganglion cells in the eye. This examination is carried out by a trained ophthalmologist.

  12. Electrorectinography

    Time frame: 3 months after injection

    an examination to provide a picture of objectivity, a quantitative measure of retinal function to monitor the function of stem cells and ganglion cells in the eye. This examination is carried out by a trained ophthalmologist.

  13. Optical Coherence Tomography (OCT)

    Time frame: 1 week after injection

    is a diagnostic test that give the information about posterior segment structure, which is retina and optic nerve papillae so that it can be used to assess macular abnormalities

  14. Optical Coherence Tomography (OCT)

    Time frame: 1 month after injection

    is a diagnostic test that give the information about posterior segment structure, which is retina and optic nerve papillae so that it can be used to assess macular abnormalities

  15. Optical Coherence Tomography (OCT)

    Time frame: 3 months after injection

    is a diagnostic test that give the information about posterior segment structure, which is retina and optic nerve papillae so that it can be used to assess macular abnormalities

  16. Angiography

    Time frame: 1 week after injection

    a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.

  17. Angiography

    Time frame: 1 month after injection

    a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.

  18. Angiography

    Time frame: 3 months after injection

    a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.

Sponsors and collaborators

Lead sponsor

PT. Prodia Stem Cell Indonesia

Industry

Registry information

Official study title

Safety Issues of Peribulbar Injection of Umbilical Cord Mesenchymal Stem Cell (UC-MSC) in Patients With Retinitis Pigmentosa

Acronym: RP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2020
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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