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Stem Cell Ophthalmology Treatment Study II (SCOTS2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03011541
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : April 16, 2024
Sponsor:
Information provided by (Responsible Party):
MD Stem Cells

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Retinal Disease Age-Related Macular Degeneration Retinitis Pigmentosa Stargardt Disease Optic Neuropathy Nonarteritic Ischemic Optic Neuropathy Optic Atrophy Optic Nerve Disease Glaucoma Leber Hereditary Optic Neuropathy Blindness Vision Loss Night Vision Loss Partial Vision, Low Retinopathy Maculopathy Macular Degeneration Retina Atrophy Procedure: Arm 1 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Arm- Arm 1. Comparator is natural history of the disease.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II
Actual Study Start Date : January 2016
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : July 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011541


Contacts
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Contact: Steven Levy, MD 203-423-9494 stevenlevy@mdstemcells.com
Contact: Steven Levy, MD 203-423-9494

Locations
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United States, Connecticut
MD Stem Cells Recruiting
Westport, Connecticut, United States, 06880
Contact: Steven Levy, MD    203-423-9494    stevenlevy@mdstemcells.com   
Contact: Steven Levy, MD    203-423-9494      
Sub-Investigator: Steven Levy, MD         
Principal Investigator: Jeffrey Weiss, MD         
United States, Florida
MD Stem Cells Recruiting
Coral Springs, Florida, United States, 33065
Contact: Steven Levy, MD    203-423-9494      
United Arab Emirates
Medcare Orthopaedics & Spine Hospital Recruiting
Dubai, United Arab Emirates
Contact: Steven Levy, MD    (001) 2034239494      
Sponsors and Collaborators
MD Stem Cells
Investigators
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Study Chair: Steven Levy, MD MD Stem Cells
Principal Investigator: Jeffrey Weiss, MD Coral Springs
More Information
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Publications of Results:

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Responsible Party: MD Stem Cells
ClinicalTrials.gov Identifier: NCT03011541    
Other Study ID Numbers: SCOTS2
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: April 16, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators do not plan to share individual participant data (IPD)
Keywords provided by MD Stem Cells:
Stargardt Disease
Stem Cells
Bone Marrow Derived Stem Cells
BMSC
Mesenchymal Stem Cells
MSC
Eye Disease
Ophthalmology
Ophthalmic Disease
Retina
Retinal Disease
Macular Degeneration
Age Related Macular Degeneration
Myopic Macular Degeneration
Geographic Atrophy
 Dry Macular Degeneration
Wet Macular Degeneration
Retinal Atrophy
Retinal Dystrophy
Hereditary Retinal Dystrophy
Malattia Leventinese
Retinitis Pigmentosa
Cone Dystrophy
Rod-Cone Dystrophy
Cone-Rod Dystrophy
Maculopathy
Optic Nerve Disease
Optic Atrophy
Optic Neuropathy
Ischemic Optic Neuropathy
Additional relevant MeSH terms:
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Stargardt Disease
Peripheral Nervous System Diseases
Optic Nerve Diseases
Blindness
Optic Neuropathy, Ischemic
Optic Atrophy, Hereditary, Leber
Nervous System Diseases
Optic Atrophy
Vision, Low
Macular Degeneration
Retinal Diseases
Retinitis
Retinitis Pigmentosa
Atrophy
Eye Diseases
 Neuromuscular Diseases
Retinal Degeneration
Pathological Conditions, Anatomical
Eye Diseases, Hereditary
Retinal Dystrophies
Genetic Diseases, Inborn
Cranial Nerve Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Vascular Diseases
Cardiovascular Diseases
Optic Atrophies, Hereditary
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases