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

PT. Prodia Stem Cell Indonesia18 enrolled

Overview

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.

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

Conditions

Retinitis Pigmentosa

Interventions

Conditioned Medium (CM)BIOLOGICAL

Conditioned Medium (CM) injected by peribulbar

Umbilical Cord Mesenchymal Stem Cell (UC-MSC)BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (2)

Jakarta Eye Center Hospital

Jakarta, DKI Jakarta, Indonesia

Sardjito Hospital

Yogyakarta, Special Region, Indonesia

Outcomes

Primary Outcomes

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.