NCT05909488

Brief Summary

The study will perform UC-MSCs and CM transplantation. There are two groups with different dosages. The first group will be transplanted with 1.5 million cells, meanwhile, the second group is 5 million cells. Each group consists of 30 subjects. All groups will be transplanted via the peribulbar route. All groups will be observed until six months.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
16mo left

Started May 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Sep 2027

First Submitted

Initial submission to the registry

March 14, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
2.9 years until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

March 14, 2023

Last Update Submit

February 23, 2026

Conditions

Retinitis Pigmentosa

Keywords

Allogeneic Mesenchymal Stem CellUmbilical Cord Mesenchymal Stem CellConditioned MediumAllogeneic Umbilical Cord Mesenchymal Stem Cell

Outcome Measures

Primary Outcomes (24)

  • Incident of Adverse Events

    assessment of infection, inflammation, eye pressure and patients complaints

    1 day after injection

  • Incident of Adverse Events

    assessment of infection, inflammation, eye pressure and patients complaints

    1 week after injection

  • Frequency of Adverse Events

    assessment of infection, inflammation, eye pressure and patients complaints

    1 day after injection

  • Frequency of Adverse Events

    assessment of infection, inflammation, eye pressure and patients complaints

    1 week after injection

  • 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.

    1 week after injection

  • 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.

    1 month after injection

  • 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.

    3 months after injection

  • 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.

    6 months after injection

  • Visual Field Test

    a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.

    1 week after injection

  • Visual Field Test

    a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.

    1 month after injection

  • Visual Field Test

    a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.

    3 months after injection

  • Visual Field Test

    a test to assess the breadth of views of the lateral, medial, superior and inferior aspects using Humphrey's perimetry.

    6 months after injection

  • 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.

    1 week after injection

  • 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.

    1 month after injection

  • 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.

    3 months after injection

  • 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.

    6 months after injection

  • 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.

    1 week after injection

  • 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.

    1 month after injection

  • 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.

    3 months after injection

  • 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.

    6 months after injection

  • 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.

    1 week after injection

  • 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.

    1 month after injection

  • 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.

    3 months after injection

  • 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.

    6 months after injection

Secondary Outcomes (6)

  • Patients Quality of Life

    1 week after injection

  • Patients Quality of Life

    1 month after injection

  • Patients Quality of Life

    3 months after injection

  • Patients Quality of Life

    6 months after injection

  • Pain evaluation

    6 months after injection

  • +1 more secondary outcomes

Study Arms (2)

EYESTEM 001-X

EXPERIMENTAL

1.8 ml cell preparations are suspended in Conditioned Media (CM) until it reaches a 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) suspension will be injected into the peribulbar.

Biological: 1.5 x 10^6 UC-MSC + CM

EYESTEM 001-XF

EXPERIMENTAL

1.8 ml cell preparations are suspended in Conditioned Media (CM) until it reaches a 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) suspension will be injected into the peribulbar.

Biological: 5 x 10^6 UC-MSC + CM

Interventions

1.5 x 10^6 UC-MSC + CMBIOLOGICAL

1.5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)

EYESTEM 001-X
5 x 10^6 UC-MSC + CMBIOLOGICAL

5 million cells of UC-MSC in 2 ml of Conditioned Medium (CM)

EYESTEM 001-XF

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Visus more than 20/100
  • Have more than 0.68 uV on conical receptor cell amplitude checked by ERG
  • Visual field equivalent diameter more than 10o
  • 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

You may not qualify if:

  • Pregnant or nursing women
  • Positive result of HIV test
  • Have a history of eye tumors
  • Under 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RSUP Dr. Sardjito

Yogyakarta, DI Yogyakarta, 55284, Indonesia

Location

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD

    Gadjah Mada University, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

  • Cosmos Mangunsong, Doctor

    Jakarta Eye Center

    STUDY CHAIR

  • dr. Rifa Widyaningrum, M.Sc, PhD

    Sardjito Hospital

    STUDY CHAIR

Central Study Contacts

dr. Muhammad B Sasongko, Sp.M, M.Epid, PhD

CONTACT

+62811293476mb.sasongko@ugm.ac.id

Dr. Cynthia R Sartika, M.Si

CONTACT

cynthia.sartika@prostem.co.id

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2023

First Posted

June 18, 2023

Study Start

May 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations

ID(1)