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

PT. Prodia Stem Cell Indonesia

Status: Invitation-only

Conditions: Retinitis Pigmentosa

Treatments: Biological: Conditioned Medium (CM); Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)

Study type: Observational

Funder types: Industry

Identifiers

NCT05786287

CT/RP/08/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

18 participants in 3 patient groups

Conditioned Medium (CM)

Description:

2 ml volume of Conditioned Medium derived Umbilical Cord Mesenchymal Stem Cell injected into peribulbar

Treatment:

Biological: Conditioned Medium (CM)

UC-MSC + NaCl

Description:

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

Treatment:

Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)

UC-MSC+CM

Description:

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

Treatment:

Biological: Conditioned Medium (CM)

Biological: Umbilical Cord Mesenchymal Stem Cell (UC-MSC)