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Stem Cell Therapy
Stem Cell Implantation for Retinitis Pigmentosa
Phase 1
Recruiting
Led By David Liao, MD, PhD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
4. Participant will be medically able to undergo ophthalmic surgery.
Participant with diagnosis of retinitis pigmentosa
Must not have
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
Contraindications to use of anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up performed 5 times over 15 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if introducing special cells into the eye is safe for patients with vision loss. The cells might help protect and support the existing nerve cells in the eye, potentially slowing down or stopping vision loss.
Who is the study for?
Adults diagnosed with Retinitis Pigmentosa (RP) who have visual acuity of 20/200 or worse, or a central visual field of 40 degrees diameter or less. They must be able to undergo eye surgery and sign informed consent. Excluded are those on certain medications, with allergies to specific antibiotics, recent substance abuse, ocular abnormalities that could affect the study's outcome, systemic diseases affecting ocular function, pregnant/nursing women, and unwillingness to use contraception.
What is being tested?
The trial is testing the safety of implanting CNS10-NPC cells into the subretinal space in RP patients. These neural progenitor cells are designed to become astrocytes in hopes of treating RP. This is an initial human test following animal studies.
What are the potential side effects?
Potential side effects aren't specified but may include typical risks associated with ophthalmic surgery such as infection, inflammation, vision changes or loss. There might also be immune reactions due to cell transplantation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am medically cleared for eye surgery.
Select...
I have been diagnosed with retinitis pigmentosa.
Select...
I have limited side vision.
Select...
I have been diagnosed with retinitis pigmentosa.
Select...
I have been diagnosed with retinitis pigmentosa.
Select...
I have limited side vision.
Select...
I have symptoms of retinitis pigmentosa.
Select...
I am 18 years old or older.
Select...
I have a history of night blindness.
Select...
I have changes in the color of my retina.
Select...
I have been diagnosed with retinitis pigmentosa.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not allergic to any medications or substances used in this study.
Select...
I cannot have anesthesia due to health reasons.
Select...
I can travel to the study center and understand the consent without mental impairments.
Select...
I have a history of HIV or hepatitis A, B, or C.
Select...
My eyes are healthy and have no history of conditions that could complicate surgery.
Select...
I am on or expect to be on steroids for more than a week.
Select...
I am not currently on immunosuppressant therapies and have no contraindications to them.
Select...
I have swelling in the central part of my retina.
Select...
I have G6PD deficiency.
Select...
I cannot have my pupils dilated due to a medical condition.
Select...
I am currently pregnant.
Select...
I do not have major eye problems that would affect surgery or study results.
Select...
I am not nursing or planning to nurse for 6 months after treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ performed 5 times over 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~performed 5 times over 15 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety, as evaluated by changes in Spectral Domain Optical Coherence Tomography (SD-OCT)
Safety, as evaluated by changes in Visual Acuity
Safety, as evaluated by changes in visual field
Secondary study objectives
Spectral domain optical coherence tomography (SD-OCT)
Visual Function Questionnaire-25 (VFQ-25)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
Visual acuity between 20/80 and 20/200
Single, unilateral, subretinal injection of 1,000,000 CNS10-NPC (n=10)
Group II: Group 1BExperimental Treatment1 Intervention
Visual acuity of 20/200 or worse
Single, unilateral, subretinal injection of 1,000,000 CNS10-NPC (n=3)
Group III: Group 1AExperimental Treatment1 Intervention
Visual acuity of 20/200 or worse
Single, unilateral, subretinal injection of 300,000 CNS10-NPC (n=3)
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Retinitis Pigmentosa (RP) include investigational therapies like CNS10-NPC cells, which are neural progenitor cells derived to become astrocytes and transplanted into the subretinal space to support retinal health. This approach aims to replace or support damaged retinal cells, potentially slowing disease progression.
Other treatments include vitamin A supplementation to slow retinal function decline and omega-3 fatty acids like DHA to support retinal cell structure. These treatments are crucial for RP patients as they offer potential ways to preserve vision and slow the progression of the disease.
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
509 Previous Clinical Trials
162,663 Total Patients Enrolled
California Institute for Regenerative Medicine (CIRM)OTHER
69 Previous Clinical Trials
3,342 Total Patients Enrolled
3 Trials studying Retinitis Pigmentosa
142 Patients Enrolled for Retinitis Pigmentosa
David Liao, MD, PhDPrincipal InvestigatorRetina-Vitreous Associates Medical Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am medically cleared for eye surgery.I agree to use contraception for at least 6 months after surgery.I have not had a serious illness or infection in the last 28 days.I have been diagnosed with retinitis pigmentosa.I am 18 or older and can sign the consent form.I have limited side vision.I cannot have anesthesia due to health reasons.I do not have any other illnesses that could affect my eyes or immune system.I have had cancer or a positive cancer test within the last 5 years.I can travel to the study center and understand the consent without mental impairments.I have been diagnosed with retinitis pigmentosa.I have not had eye steroid treatments in the last 4 months.I am not allergic to any medications or substances used in this study.I have been diagnosed with retinitis pigmentosa.I have a history of HIV or hepatitis A, B, or C.Waxy pallor, sometimes seen on the optic disc, is an electrophysiologic sign of rod dysfunction on full field electroretinography.Group 1 will have worse vision than Group 2.I have not had eye surgery or laser treatment in the last 12 weeks.My eyes are healthy and have no history of conditions that could complicate surgery.I am willing to use effective contraception if I can become pregnant.I do not have eye conditions like severe cataracts or glaucoma that affect vision tests.I am on or expect to be on steroids for more than a week.I am not currently on immunosuppressant therapies and have no contraindications to them.I have limited side vision.I have symptoms of retinitis pigmentosa.I haven't taken any prescription retinoids or macula-affecting drugs in the last 6 months.I am 18 years old or older.I have swelling in the central part of my retina.I have G6PD deficiency.I have a history of night blindness.I have changes in the color of my retina.I am medically cleared for eye surgery.I have been diagnosed with retinitis pigmentosa.Group 1 participants will have a central visual field with a diameter of 40 degrees or lessI cannot have my pupils dilated due to a medical condition.I am currently pregnant.I do not have major eye problems that would affect surgery or study results.I am not nursing or planning to nurse for 6 months after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1A
- Group 2: Group 1B
- Group 3: Group 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Retinitis Pigmentosa Patient Testimony for trial: Trial Name: NCT04284293 — Phase 1
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