Stem Cell Ophthalmology Treatment Study II (SCOTS2)

March 17, 2025 updated by: MD Stem Cells

Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II

This study will evaluate the use of autologous bone marrow derived stem cells (BMSC) for the treatment of retinal and optic nerve damage or disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Eyes with loss of vision from retinal or optic nerve conditions generally considered irreversible will be treated with a combination of injections of autologous bone marrow derived stem cells isolated from the bone marrow using standard medical and surgical practices. Retinal conditions may include degenerative, ischemic or physical damage ( examples may include macular degeneration, hereditary retinal dystrophies such as retinitis pigmentosa, stargardt, non-perfusion retinopathies, post retinal detachment. Optic Nerve conditions may include degenerative, ischemic or physical damage ( examples may include optic nerve damage from glaucoma, compression, ischemic optic neuropathy, optic atrophy ). Injections may include retrobulbar, subtenon, intravitreal, intraocular, subretinal and intravenous. Patients will be followed for 12 months with serial comprehensive eye examinations including relevant imaging and diagnostic ophthalmic testing.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Steven Levy, MD
  • Phone Number: 203-423-9494

Study Locations

  • Austria
      • Vienna, Austria, 1010
  • United Arab Emirates
      • Dubai, United Arab Emirates, 337-1500
        • Recruiting
        • The Saudi-German Hospital
        • Contact:
          • Jeffrey Weiss, MD
        • Contact:
  • United States
    • Connecticut
      • Westport, Connecticut, United States, 06880
        • Recruiting
        • MD Stem Cells
        • Contact:
        • Contact:
          • Steven Levy, MD
          • Phone Number: 203-423-9494
        • Contact:
          • Steven Levy, MD
        • Contact:
          • Jeffrey Weiss, MD
    • Florida
      • Coral Springs, Florida, United States, 33065
        • Recruiting
        • MD Stem Cells
        • Contact:
          • Steven Levy, MD
          • Phone Number: 203-423-9494

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 at least 3 months post-surgical treatment intended to treat any ophthalmologic disease and stable.
  • If under current medical therapy ( pharmacologic treatment) for a retinal or optic nerve disease be considered stable on that treatment and unlikely to have visual function improvement ( for example, glaucoma with intraocular pressure stable on topical medications but visual field damage ).
  • Have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.
  • Be over the age of 18
  • Be medically stable and able to be medically cleared by their primary care physician or a licensed primary care practitioner for the procedure.
  • Medical clearance means that in the estimation of the primary care practitioner, the patient can reasonably be expected to undergo the procedure without significant medical risk to health.

Exclusion Criteria:

  • Patients who are not capable of an adequate ophthalmologic examination or evaluation to document the pathology.
  • Patients who are not capable or not willing to undergo follow up eye exams with the principle investigator or their ophthalmologist or optometrist as outlined in the protocol.
  • Patients who are not capable of providing informed consent.
  • Patients who may be at significant risk to general health or to the eyes and visual function should they undergo the procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1
BMSC provided retrobulbar, subtenon and intravenous for one or both eyes
Procedure: Arm 1

Procedure/ Surgery: RB (Retrobulbar)

Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC)

Procedure/Surgery: ST (Subtenon)

Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)

Procedure/Surgery: IV (Intravenous)

Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)

Other Names:
  • Retrobulbar( RB)
  • Subtenon (ST)
  • Intravenous (IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: Change from pre-procedure to 12 months
Best corrected visual acuity will be measured with Snellen Eye Chart and the ETDRS (Early Treatment Diabetic Retinopathy Study)Eye Chart when available at each post- procedure visit. Intervals at minimum will be first post- procedure day,then 3 months, 6 months and 12 months post-procedure day. Recommended visit 1 month post -procedure day.
Change from pre-procedure to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Fields
Time Frame: Change from pre-procedure to 12 months
Visual fields will be evaluated with automated perimetry during post- procedure visits as needed and specifically at 6 months and 12 months. Visual fields are a key measurement in patients with peripheral vision loss.
Change from pre-procedure to 12 months
Optical Coherence Tomography (OCT)
Time Frame: Change from pre-procedure to 12 months
OCT thickness of the retinal nerve fiber layer the optic nerve and/or macula during the post- procedure visits as needed and specifically at 6 and 12 months - if available.
Change from pre-procedure to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MD Stem Cells

Investigators

  • Study Chair: Steven Levy, MD, MD Stem Cells
  • Principal Investigator: Jeffrey Weiss, MD, Coral Springs Florida, Vienna Austria, Dubai UAE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

January 1, 2017

First Submitted That Met QC Criteria

January 3, 2017

First Posted (Estimated)

January 5, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCOTS2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators do not plan to share individual participant data (IPD)

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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