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Safety Issues of Peribulbar Injection of UC-MSC in Patients With Retinitis Pigmentosa (RP)

Primary Purpose

Retinitis Pigmentosa

Status

Completed

Phase

Phase 1

Locations

Indonesia

Study Type

Interventional

Intervention

Umbilical Cord Mesenchymal Stem Cell (UC-MSC)

Conditioned Medium (CM)

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring Allogeneic Mesenchymal Stem Cell, Umbilical Cord Mesenchymal Stem Cell, Conditioned Medium, Allogeneic Umbilical Cord Mesenchymal Stem Cell

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Visual field defects at initial examination with Humhprey perimetry are between 25% to 50%
Willing to sign informed consent as research subjects
Willing to do 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 Coherrent 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 tumors
In 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)

Sites / Locations

Jakarta Eye Center Hospital
Sardjito Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Conditioned Medium (CM)

UC-MSC + NaCl

UC-MSC+CM

Arm Description

a total 2 ml volume of Conditioned Medium derived Umbilical Cord Mesenchymal Stem Cell will be injected by peribulbar

1.8 ml cell preparations are suspended in physiological NaCl until it reaches a total of 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) suspension will be injected by peribulbar

1.8 ml cell preparations are suspended in Conditioned Medium (CM) until it reaches total of 2 ml volume of cell suspension. Umbilical Cord Mesenchymal Stem Cell (UC-MSC) + Conditioned Medium (CM) suspension will be injected by peribulbar

Outcomes

Primary Outcome Measures

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.

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.

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.

Visual Field Test

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

Visual Field Test

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

Visual Field Test

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

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.

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.

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.

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.

Electrorectinography

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

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

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

Angiography

a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.

Angiography

a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.

Angiography

a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.

Secondary Outcome Measures

Full Information

NCT ID

NCT04315025

First Posted

March 8, 2020

Last Updated

June 2, 2020

Sponsor

PT. Prodia Stem Cell Indonesia

1. Study Identification

Unique Protocol Identification Number

NCT04315025

Brief Title

Safety Issues of Peribulbar Injection of UC-MSC in Patients With Retinitis Pigmentosa

Acronym

Official Title

Safety Issues of Peribulbar Injection of Umbilical Cord Mesenchymal Stem Cell (UC-MSC) in Patients With Retinitis Pigmentosa

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

October 7, 2018 (Actual)

Primary Completion Date

June 20, 2019 (Actual)

Study Completion Date

September 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PT. Prodia Stem Cell Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study will perform UC-MSCs and CM transplantation. The first group will be injected by UCMSC+NaCl. the 2nd group will be injected by UC-MSC+CM. the 3rd group will be injected by CM. Each group consists of 6 subjects. all groups will be transplanted via peribulbar route. the dosage of UC-MSC is 1 million cells for each subject. All groups will be observed until 6 months.

Detailed Description

The eyes which will give the transplant should be given an aseptic and antiseptic technique to prevent the contamination from the inside and outside. Sterile cover attached to other parts of the face except for the eyes. 1.8 ml cell preparations are suspended in physiological NaCl until it reaches a total of 2 ml volume of cell suspension (for UC-MSC + NaCl group). Stem cell suspension will be injected by peribulbar and if the injection was done, patients will be given a quinolone antibiotic. On day 1st and day 7th after therapy, patients will be observed the presence of infection, inflammation, and increasing of eye pressure. On day 7th, day 30th, and day 90th after therapy, 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. After the data was completed, then make a discussion, conclusion, and suggestion of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinitis Pigmentosa

Keywords

Allogeneic Mesenchymal Stem Cell, Umbilical Cord Mesenchymal Stem Cell, Conditioned Medium, Allogeneic Umbilical Cord Mesenchymal Stem Cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conditioned Medium (CM)

Arm Type

Active Comparator

Arm Description

a total 2 ml volume of Conditioned Medium derived Umbilical Cord Mesenchymal Stem Cell will be injected by peribulbar

Arm Title

UC-MSC + NaCl

Arm Type

Active Comparator

Arm Description

Arm Title

UC-MSC+CM

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Umbilical Cord Mesenchymal Stem Cell (UC-MSC)

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Conditioned Medium (CM)

Intervention Description

Conditioned Medium (CM) injected by peribulbar

Primary Outcome Measure Information:

Title

Visual Acuity Test

Description

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

1 week after injection

Title

Visual Acuity Test

Description

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

1 month after injection

Title

Visual Acuity Test

Description

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

3 months after injection

Title

Visual Field Test

Description

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

Time Frame

1 week after injection

Title

Visual Field Test

Description

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

Time Frame

1 month after injection

Title

Visual Field Test

Description

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

Time Frame

3 months after injection

Title

Funduscopy

Description

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

1 week after injection

Title

Funduscopy

Description

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

1 month after injection

Title

Funduscopy

Description

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

3 months after injection

Title

Electrorectinography

Description

Time Frame

1 week after injection

Title

Electrorectinography

Description

Time Frame

1 month after injection

Title

Electrorectinography

Description

Time Frame

3 months after injection

Title

Optical Coherence Tomography (OCT)

Description

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

Time Frame

1 week after injection

Title

Optical Coherence Tomography (OCT)

Description

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

Time Frame

1 month after injection

Title

Optical Coherence Tomography (OCT)

Description

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

Time Frame

3 months after injection

Title

Angiography

Description

a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.

Time Frame

1 week after injection

Title

Angiography

Description

a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.

Time Frame

1 month after injection

Title

Angiography

Description

a process of taking photos of the retina by injecting fluorescent to get a bleeding location on the retina.

Time Frame

3 months after injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Visual field defects at initial examination with Humhprey perimetry are between 25% to 50% Willing to sign informed consent as research subjects Willing to do 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 Coherrent 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 tumors In 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)

Overall Study Officials: