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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from pre-procedure to 12 months

Awards & highlights

SCOTS2 Trial Summary

This trial will test whether injecting stem cells derived from a patient's own bone marrow can help treat damage to the retina or optic nerve.

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.Check my eligibility

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.See study design

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.

SCOTS2 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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.

Select...

I am over 18 years old.

Select...

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

Select...

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

Select...

I am over 18 years old.

SCOTS2 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Visual Acuity

Secondary outcome measures

Optical Coherence Tomography (OCT)

Visual Fields

SCOTS2 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

~1190

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

MD Stem CellsLead Sponsor

4 Previous Clinical Trials

940 Total Patients Enrolled

Steven Levy, MDStudy ChairMD Stem Cells

4 Previous Clinical Trials

940 Total Patients Enrolled

Jeffrey Weiss, MDPrincipal InvestigatorCoral Springs

4 Previous Clinical Trials

940 Total Patients Enrolled

Media Library

Arm 1 (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03011541 — N/A

Fundus Flavimaculatus Research Study Groups: Arm 1

Fundus Flavimaculatus Clinical Trial 2023: Arm 1 Highlights & Side Effects. Trial Name: NCT03011541 — N/A

Arm 1 (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03011541 — N/A

Fundus Flavimaculatus Patient Testimony for trial: Trial Name: NCT03011541 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this examination currently enrolling participants?

"Per the clinicaltrials.gov listing, recruitment is still open for this experiment that was initially posted on January 1st 2016 and revised lastly in November 25th 2022."

Answered by AI

To what extent is participation in this medical experiment limited?

"Affirmative. According to the information published on clinicaltrials.gov, this medical trial is currently recruiting participants and was initially posted on New Year's Day 2016 before being updated in November 2022. The research team are hoping to enrol 500 patients from two different sites."

Answered by AI