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Stem Cell Ophthalmology Treatment Study II (SCOTS2)

This study is currently recruiting participants.
Verified July 2017 by MD Stem Cells
Sponsor:
ClinicalTrials.gov Identifier:
NCT03011541
First Posted: January 5, 2017
Last Update Posted: July 21, 2017
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.
Information provided by (Responsible Party):
MD Stem Cells
  Purpose
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 Intervention
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 Procedure: Arm 1 Procedure: Arm 2 Procedure: Arm 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II

Resource links provided by NLM:


Further study details as provided by MD Stem Cells:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.


Estimated Enrollment: 500
Study Start Date: January 2016
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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)
Active Comparator: Arm 2
BMSC provided retrobulbar, subtenon, intravitreal and intravenous for one or both eyes
Procedure: Arm 2

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)

Procedure/Surgery: IVIT (Intravitreal)

Intravitreal injection of Bone Marrow Derived Stem Cells (BMSC)

Other Names:
  • Retrobulbar (RB)
  • Subtenon (ST)
  • Intravitreal (IVIT)
  • Intravenous (IV)
Active Comparator: Arm 3
BMSC provided either intraoptic nerve or subretinal for eye with worse vision with fellow eye receiving either retrobulbar and subtenon or retrobulbar, subtenon and intravitreal; followed by intravenous.
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)
Procedure: Arm 2

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)

Procedure/Surgery: IVIT (Intravitreal)

Intravitreal injection of Bone Marrow Derived Stem Cells (BMSC)

Other Names:
  • Retrobulbar (RB)
  • Subtenon (ST)
  • Intravitreal (IVIT)
  • Intravenous (IV)
Procedure: Arm 3

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)

Procedure/Surgery: IO (Intraocular)

Intraocular injection of Bone Marrow Derived Stem Cells (BMSC) with vitrectomy prior to intraocular injection. For example, may include larger amount of stem cells in the intravitreal cavity, intraneuronal injections or subretinal injections of stem cells.

Other Names:
  • Retrobulbar (RB)
  • Subtenon (ST)
  • Intravitreal (IVIT)
  • Intravenous (IV)
  • Intraocular (IO)

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 20/40 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
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
Contact: Steven Levy, MD 203-423-9494 stevenlevy@mdstemcells.com

Locations
United States, Florida
The Healing Institute Recruiting
Margate, Florida, United States, 33063
Contact: Steven Levy, MD    203-423-9494    stevenlevy@mdstemcells.com   
Principal Investigator: Jeffrey N Weiss, MD         
United Arab Emirates
Al Zahra Hospital Enrolling by invitation
Dubai, United Arab Emirates
Sponsors and Collaborators
MD Stem Cells
Investigators
Study Director: Steven Levy, MD MD Stem Cells
Principal Investigator: Jeffrey N Weiss, MD The Healing Institute
  More Information

Additional Information:
Publications:
Responsible Party: MD Stem Cells
ClinicalTrials.gov Identifier: NCT03011541     History of Changes
Other Study ID Numbers: SCOTS2
First Submitted: January 1, 2017
First Posted: January 5, 2017
Last Update Posted: July 21, 2017
Last Verified: July 2017
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:
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
Stargardt Disease
Cone Dystrophy
Rod-Cone Dystrophy
Cone-Rod Dystrophy
Maculopathy
Optic Nerve Disease
Optic Atrophy
Optic Neuropathy
Ischemic Optic Neuropathy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Macular Degeneration
Atrophy
Retinitis
Retinitis Pigmentosa
Cone-Rod Dystrophies
Optic Nerve Diseases
Retinal Diseases
Optic Neuropathy, Ischemic
Optic Atrophy, Hereditary, Leber
Nervous System Diseases
Optic Atrophy
Neuromuscular Diseases
Retinal Degeneration
Eye Diseases
Pathological Conditions, Anatomical
Eye Diseases, Hereditary
Retinal Dystrophies
Genetic Diseases, Inborn
Cranial Nerve Diseases
Vascular Diseases
Cardiovascular Diseases
Optic Atrophies, Hereditary
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Mitochondrial Diseases
Metabolic Diseases