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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorPT. Prodia Stem Cell Indonesia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Retinitis Pigmentosa patients who have been transplanted UC-MSC and/or CM 5 years ago under clinical trials NCT04315025

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Conditioned Medium (CM)

    Biological/Vaccine

    Conditioned Medium (CM) injected by peribulbar

  • Umbilical Cord Mesenchymal Stem Cell (UC-MSC)

    Biological/Vaccine

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

Treatment groups

18 Participants
are divided into 3 treatment groups
Group A: Conditioned Medium (CM)1 intervention
Group B: UC-MSC + NaCl1 intervention
Group C: UC-MSC+CM2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
5 years after injection
2

Visual Field Test

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

Time frame
5 years after injection
3

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.

Time frame
5 yeas after injection
4

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.

Time frame
5 years after injection

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: