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

Retinitis Pigmentosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05786287
• Other study ID #: CT/RP/08/2022
• Status: Enrolling by invitation
• Start date: July 1, 2023
• Est. completion date: July 13, 2025

Study information

• Verified date: June 2023
• Source: PT. Prodia Stem Cell Indonesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 18
• Est. completion date: July 13, 2025
• Est. primary completion date: July 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

Biological:
• Conditioned Medium (CM)
Conditioned Medium (CM) injected by peribulbar
• Umbilical Cord Mesenchymal Stem Cell (UC-MSC)
Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar

Locations

Country	Name	City	State
Indonesia	Jakarta Eye Center Hospital	Jakarta	DKI Jakarta
Indonesia	Sardjito Hospital	Yogyakarta	Special Region

Sponsors (1)

Lead Sponsor	Collaborator
PT. Prodia Stem Cell Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

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