CNS10-NPC for the Treatment of RP (NCT04284293) | Clinical Trial Compass
Active — Not RecruitingPhase 1
CNS10-NPC for the Treatment of RP
United States16 participantsStarted 2021-07-22
Plain-language summary
The investigator is examining the safety of transplanting cells into the subretinal space of patients with Retinitis Pigmentosa (RP). The cells are called neural progenitor cells, which are a type of stem cell that can become several different types of cells in the nervous system. These cells have been derived to specifically become astrocytes, which is a type of neuronal cell. The cells are called "CNS10-NPC." The investigational treatment has been tested in animals, but it has not yet been tested in people. In this study, the investigators want to learn if CNS10-NPC cells are safe to transplant into the subretinal space of people.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. To participate in this study, the subject must be 18 years of age or older and must understand and sign the protocol's informed consent.
✓. Participant with diagnosis of retinitis pigmentosa.
Exclusion criteria
✕. Presence of significant ocular abnormalities that would preclude the planned surgery or interfere with the interpretation of study endpoints (e.g. glaucoma, corneal or significant lens opacities, pre-existing uveitis, intraocular infection, macular edema, choroidal neovascularization). Any ocular diseases that the investigator feels would interfere with accurate ocular measurements. This would exclude potential subjects with significant cataract, corneal scars or significant corneal irregularities such as keratoconus, previous penetrating keratoplasty or glaucoma with central visual field.
✕. Any pre-existing factor or history of eye disease that may predispose to an increased risk of surgical complications in the study eye (e.g. trauma, previous surgery other than uncomplicated cataract surgery, uveitis, congenital developmental or structural abnormalities).
✕. Concomitant systemic diseases including those in which the disease itself, or the treatment for the disease, can alter ocular function or immune status (e.g. malignancies, uncontrolled diabetes).
What they're measuring
1
Safety as evaluated by incidence of Adverse Events (AE) and Serious Adverse Events (SAE) and their relationship to the intervention
Timeframe: Subjects will be followed postoperatively for 12 months
2
Safety, as evaluated by changes in the complete blood count
Timeframe: Subjects will be followed postoperatively for 12 months
3
Safety, as evaluated by changes in the comprehensive metabolic panel
Timeframe: Subjects will be followed postoperatively for 12 months
4
Safety, as evaluated by changes in Donor Specific Antibodies
Timeframe: Subjects will be followed postoperatively for 12 months
5
Safety, as evaluated by changes in the urinalysis
Timeframe: Subjects will be followed postoperatively for 12 months
6
Safety, as evaluated by changes in Visual Acuity
Timeframe: Subjects will be followed postoperatively for 12 months
7
Safety, as evaluated by changes in visual field
Timeframe: Subjects will be followed postoperatively for 12 months
. Any ocular surgery or laser in either eye within 12 weeks of screening.
✕. Any contraindication to pupil dilatation in either eye.
✕. Treatment with intravitreal, subtenon or periocular steroid within 4 months of enrollment.
✕. Any known allergy to any component of the delivery vehicle or diagnostic agents used during the study (e.g., dilation drops), or medications planned for use during the peri-operative period including corticosteroids, tacrolimus and mycophenolate.
✕. Imminently life-threatening illness.
Safety, as evaluated by changes in Spectral Domain Optical Coherence Tomography (SD-OCT)
Timeframe: Subjects will be followed postoperatively for 12 months