Long-term Safety of UC-MSC Transplantation in Patients With Retinitis Pigmentosa

June 11, 2023 updated by: PT. Prodia Stem Cell Indonesia

Long-term Safety of Umbilical Cord-Mesenchymal Stem Cell (UC-MSC) Transplantation in Patients With Retinitis Pigmentosa

The study will perform to follow-up UC-MSCs and CM transplantation. 18 patients will be called back to be examined after 5 years of UC-MSC and/or CM transplantation.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The study will be performed on 18 patients who received UC-MSC and CM transplantation in 2018. The study is included as retrospective cohort since the transplantation happened 5 years ago. 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.The study will be performed at Rumah Sakit Jakarta Eye Center and Rumah Sakit Umum Pusat Dr. Sardjito Yogyakarta.

Study Type

Observational

Enrollment (Estimated)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia
        • Jakarta Eye Center Hospital
    • Special Region
      • Yogyakarta, Special Region, Indonesia, 55284
        • Sardjito Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Retinitis Pigmentosa patients who have been transplanted UC-MSC and/or CM 5 years ago under clinical trials NCT04315025

Description

Inclusion Criteria:

  • Visual field defects at the initial examination with Humphrey perimetry are between 25% to 50%
  • Willing to sign informed consent as research subjects
  • Willing to do the 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 Coherent 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 tumours
  • In the 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Conditioned Medium (CM)
2 ml volume of Conditioned Medium derived Umbilical Cord Mesenchymal Stem Cell injected into peribulbar
Biological: Conditioned Medium (CM)
Conditioned Medium (CM) injected by peribulbar
UC-MSC + NaCl
1.8 ml cell preparations are suspended in physiological NaCl until it reaches a 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) suspension injected into peribulbar
Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)
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 a total of 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) + Conditioned Medium (CM) suspension injected into peribulbar
Biological: Conditioned Medium (CM)
Conditioned Medium (CM) injected by peribulbar
Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)
Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity Test
Time Frame: 5 years 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.
5 years after injection
Visual Field Test
Time Frame: 5 years after injection
a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humprey's perimetry.
5 years after injection
Funduscopy
Time Frame: 5 yeas 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.
5 yeas after injection
Electrorectinography
Time Frame: 5 years 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.
5 years after injection
Optical Coherence Tomography (OCT)
Time Frame: 5 years 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
5 years after injection
Angiography
Time Frame: 5 years after injection
a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.
5 years after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PT. Prodia Stem Cell Indonesia

Investigators

  • Principal Investigator: dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD, Gadjah Mada University, Faculty of Medicine
  • Study Director: dr Cosmos O Mangunsong, Sp.M, Jakarta Eye Center
  • Study Chair: dr. Rifa Widyaningrum, M.Sc, PhD, Sardjito Hospital
  • Study Chair: Rima Haifa, S.Si, Prodia StemCell Indonesia
  • Study Chair: Marsya N Kirana, S.T., M.Sc, Prodia StemCell Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

July 13, 2025

Study Completion (Estimated)

July 13, 2025

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 11, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/RP/08/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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