Clinical trial NCT05786287: Long-term Safety of UC-MSC Transplantation in Patients With Retinitis Pigmentosa
Official title: Long-term Safety of Umbilical Cord-Mesenchymal Stem Cell (UC-MSC) Transplantation in Patients With Retinitis Pigmentosa
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Retinitis Pigmentosa
Keywords: Allogeneic Mesenchymal Stem Cell
Umbilical Cord Mesenchymal Stem Cell
Conditioned Medium
Allogeneic Umbilical Cord Mesenchymal Stem Cell
Safety
Lead sponsor: PT. Prodia Stem Cell Indonesia
Sponsor class: INDUSTRY
First posted: 2023-03-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Visual Acuity Test
timeFrame: 5 years after injection
measure: Visual Field Test
timeFrame: 5 years after injection
measure: Funduscopy
timeFrame: 5 yeas after injection
measure: Electrorectinography
timeFrame: 5 years after injection
measure: Optical Coherence Tomography (OCT)
timeFrame: 5 years after injection
measure: Angiography
timeFrame: 5 years after injection
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Jakarta Eye Center Hospital
state: DKI Jakarta
city: Yogyakarta
country: Indonesia
facility: Sardjito Hospital
state: Special Region
Study officials:
affiliation: Gadjah Mada University, Faculty of Medicine
name: dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jakarta Eye Center
name: dr Cosmos O Mangunsong, Sp.M
role: STUDY_DIRECTOR
affiliation: Sardjito Hospital
name: dr. Rifa Widyaningrum, M.Sc, PhD
role: STUDY_CHAIR
affiliation: Prodia StemCell Indonesia
name: Rima Haifa, S.Si
role: STUDY_CHAIR
affiliation: Prodia StemCell Indonesia
name: Marsya N Kirana, S.T., M.Sc
role: STUDY_CHAIR
References: