Role of UC-MSC and CM to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II

PT. Prodia Stem Cell Indonesia

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Retinitis Pigmentosa

Treatments: Biological: 1.5 x 10^6 UC-MSC + CM; Biological: 5 x 10^6 UC-MSC + CM

Study type: Interventional

Funder types: Industry

Identifiers

NCT05909488

CT/RP/06/2022

Details and patient eligibility

About

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.

Full description

The eyes we will give the transplant should be given an aseptic and antiseptic technique to prevent contamination from the inside and outside. Sterile cover attached to other parts of the face except for the eyes. 1.8 ml Umbilical Cord-derived Mesenchymal Stem Cell (UC-MSC) preparations are suspended in Conditioned Medium (CM) until it reaches a 2 ml volume of cell suspension. Two dosages will be prepared, 1.5 million and 5 million of UC-MSC. Stem cell suspension will be injected by peribulbar, and patients will be given a quinolone antibiotic if the injection is done. On day 1st and day 7th after therapy, patients will be observed the presence of infection, inflammation, and increased 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 observations will be written in the table and analyzed by a statistic.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

EYESTEM 001-X

Experimental group

Description:

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.

Treatment:

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

EYESTEM 001-XF

Experimental group

Description:

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.

Treatment:

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