What side effects are associated with this type of intervention?

Common treatments for Fundus Flavimaculatus, particularly those involving autologous bone marrow derived stem cells, may include side effects such as retinal detachment, inflammation, and potential vision loss. Other treatments, like anti-VEGF injections, can lead to ocular side effects such as increased intraocular pressure, endophthalmitis, and cataracts. It is crucial to discuss these potential risks with a healthcare provider to make an informed decision.

What prior FDA approvals exist?

Fundus Flavimaculatus, also known as Stargardt disease, has seen various investigational treatments, including gene therapy and stem cell therapy. The trial involving autologous bone marrow-derived stem cells (BMSC) is exploring their potential for treating retinal and optic nerve damage. While there are no specific FDA-approved stem cell treatments for Stargardt disease, other approaches like gene therapy using EIAV-ABCA4 have been studied, showing some promise in early trials. Traditional treatments have focused on managing symptoms and slowing disease progression rather than curing the condition.

What other types of research exist?

Promising novel alternatives for Fundus Flavimaculatus patients in 2024 include anti-VEGF therapies such as aflibercept, bevacizumab, and ranibizumab, which have shown efficacy in treating retinal diseases. Additionally, the development of new pharmacological agents like FOV-2304 for diabetic macular edema and PHA-666859 for diabetic retinopathy may offer potential benefits. Research into the use of tristetraprolin for suppressing choroidal neovascularization and the exploration of other growth factor inhibitors also present promising avenues for treatment.

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Stem Cell Therapy

Stem Cell Therapy for Retinal and Optic Nerve Disorders (SCOTS2 Trial)

N/A

Recruiting

Led By Jeffrey Weiss, MD

Research Sponsored by MD Stem Cells

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have objective, documented damage to the retina or optic nerve unlikely to improve OR Have objective, documented damage to the retina or optic nerve that is progressive AND have less than or equal to 20/30 best corrected central visual acuity in one or both eyes AND/OR an abnormal visual field in one or both eyes.

Be over the age of 18

Must not have

Patients who are not capable of an adequate ophthalmologic examination or evaluation to document the pathology

Patients who are not capable of providing informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from pre-procedure to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will use stem cells from patients' own bone marrow to treat severe vision loss caused by retinal or optic nerve damage. The stem cells will be injected into the eye to help repair the damaged tissues. SCOTS is the largest ophthalmology stem cell study registered at the National Institutes of Health, using autologous bone marrow-derived stem cells for retinal and optic nerve diseases.

Who is the study for?

Adults over 18 with progressive or stable damage to the retina or optic nerve, and vision no better than 20/30. They must be medically stable for the procedure, have potential to improve with BMSC treatment, and not at high risk from it. Excluded are those unable to consent, at significant health risk if treated, unable to undergo proper eye exams, or unwilling to follow up as required.

What is being tested?

The trial is testing autologous bone marrow derived stem cells (BMSC) therapy on individuals with various retinal and optic nerve diseases. The goal is to assess whether this treatment can repair damaged tissues in conditions that lead to blindness or low vision.

What are the potential side effects?

While specific side effects are not listed here, typical risks may include reactions at the extraction site of bone marrow, infection risk due to stem cell transplantation procedures and possible immune system responses against transplanted cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have documented damage to my retina or optic nerve that won't improve or is getting worse, and my vision is 20/30 or worse.

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I am over 18 years old.

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I have documented damage to my retina or optic nerve that won't improve, with vision 20/30 or worse.

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I have worsening eye damage and my vision is 20/30 or worse, or I have abnormal vision fields.

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot undergo a thorough eye exam to document any eye conditions.

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I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from pre-procedure to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from pre-procedure to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from pre-procedure to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Visual Acuity

Secondary study objectives

Optical Coherence Tomography (OCT)

Visual Fields

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment1 Intervention

BMSC provided retrobulbar, subtenon and intravenous for one or both eyes

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Arm 1

2020

N/A

~1340

0 / 7Eligibility criteria met

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

Fundus Flavimaculatus, or Stargardt disease, is treated with methods aimed at slowing progression and managing symptoms. Autologous Bone Marrow Derived Stem Cells (BMSC) are being explored for their ability to differentiate into retinal cells and their paracrine effects, which involve secreting growth factors and cytokines to promote tissue repair and reduce inflammation. This is crucial for patients as it offers a potential to restore retinal function and slow disease progression, addressing the root cause of cellular damage.

Florid diabetic retinopathy and its response to treatment by photocoagulation or pituitary ablation.Real-world outcomes of intravitreal anti-vascular endothelial growth factor monotherapy in proliferative type 2 macular telangiectasia.[Clinical observation on macular edema treated with treating different diseases with the same acupuncture comprehensive therapy].