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Stem Cell Ophthalmology Treatment Study II (SCOTS2)

Primary Purpose

Retinal Disease, Age-Related Macular Degeneration, Retinitis Pigmentosa

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Arm 1
Sponsored by
MD Stem Cells
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Disease focused on measuring 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, Optic Nerve Damage, Optic Nerve Compression, Compressive Optic Neuropathy, Devics Syndrome, Ushers Syndrome, Neuromyelitis Optica, Dominant Optic Atrophy, Kjers Optic Atrophy, Leber Hereditary Optic Neuropathy, Blindness, Vision Loss, Retina Atrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MD Stem CellsRecruiting
  • MD Stem CellsRecruiting
  • Medcare Orthopaedics & Spine HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

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

Outcomes

Primary Outcome Measures

Visual Acuity
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
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)
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.

Full Information

First Posted
January 1, 2017
Last Updated
June 5, 2023
Sponsor
MD Stem Cells
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1. Study Identification

Unique Protocol Identification Number
NCT03011541
Brief Title
Stem Cell Ophthalmology Treatment Study II
Acronym
SCOTS2
Official Title
Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2016 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MD Stem Cells

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
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, Optic Nerve Damage, Optic Nerve Compression, Compressive Optic Neuropathy, Devics Syndrome, Ushers Syndrome, Neuromyelitis Optica, Dominant Optic Atrophy, Kjers Optic Atrophy, Leber Hereditary Optic Neuropathy, Blindness, Vision Loss, Retina Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Arm- Arm 1. Comparator is natural history of the disease.
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Arm Description
BMSC provided retrobulbar, subtenon and intravenous for one or both eyes
Intervention Type
Procedure
Intervention Name(s)
Arm 1
Other Intervention Name(s)
Retrobulbar( RB), Subtenon (ST), Intravenous (IV)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Visual Acuity
Description
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.
Time Frame
Change from pre-procedure to 12 months
Secondary Outcome Measure Information:
Title
Visual Fields
Description
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.
Time Frame
Change from pre-procedure to 12 months
Title
Optical Coherence Tomography (OCT)
Description
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.
Time Frame
Change from pre-procedure to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Levy, MD
Phone
203-423-9494
Email
stevenlevy@mdstemcells.com
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Levy, MD
Phone
203-423-9494
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Levy, MD
Organizational Affiliation
MD Stem Cells
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jeffrey Weiss, MD
Organizational Affiliation
Coral Springs
Official's Role
Principal Investigator
Facility Information:
Facility Name
MD Stem Cells
City
Westport
State/Province
Connecticut
ZIP/Postal Code
06880
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Levy, MD
Phone
203-423-9494
Email
stevenlevy@mdstemcells.com
First Name & Middle Initial & Last Name & Degree
Steven Levy, MD
Phone
203-423-9494
First Name & Middle Initial & Last Name & Degree
Steven Levy, MD
First Name & Middle Initial & Last Name & Degree
Jeffrey Weiss, MD
Facility Name
MD Stem Cells
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Levy, MD
Phone
203-423-9494
Facility Name
Medcare Orthopaedics & Spine Hospital
City
Dubai
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Levy, MD
Phone
(001) 2034239494

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators do not plan to share individual participant data (IPD)
Citations:
PubMed Identifier
26199618
Citation
Weiss JN, Levy S, Malkin A. Stem Cell Ophthalmology Treatment Study (SCOTS) for retinal and optic nerve diseases: a preliminary report. Neural Regen Res. 2015 Jun;10(6):982-8. doi: 10.4103/1673-5374.158365.
Results Reference
result
PubMed Identifier
26604914
Citation
Weiss JN, Levy S, Benes SC. Stem Cell Ophthalmology Treatment Study (SCOTS) for retinal and optic nerve diseases: a case report of improvement in relapsing auto-immune optic neuropathy. Neural Regen Res. 2015 Sep;10(9):1507-15. doi: 10.4103/1673-5374.165525.
Results Reference
result
PubMed Identifier
27857759
Citation
Weiss JN, Benes SC, Levy S. Stem Cell Ophthalmology Treatment Study (SCOTS): improvement in serpiginous choroidopathy following autologous bone marrow derived stem cell treatment. Neural Regen Res. 2016 Sep;11(9):1512-1516. doi: 10.4103/1673-5374.191229.
Results Reference
result
PubMed Identifier
27904503
Citation
Weiss JN, Levy S, Benes SC. Stem Cell Ophthalmology Treatment Study (SCOTS): bone marrow-derived stem cells in the treatment of Leber's hereditary optic neuropathy. Neural Regen Res. 2016 Oct;11(10):1685-1694. doi: 10.4103/1673-5374.193251.
Results Reference
result
PubMed Identifier
29270420
Citation
Weiss JN, Levy S, Benes SC. Stem Cell Ophthalmology Treatment Study: bone marrow derived stem cells in the treatment of non-arteritic ischemic optic neuropathy (NAION). Stem Cell Investig. 2017 Nov 23;4:94. doi: 10.21037/sci.2017.11.05. eCollection 2017.
Results Reference
result
PubMed Identifier
30050918
Citation
Weiss JN, Levy S. Stem Cell Ophthalmology Treatment Study: bone marrow derived stem cells in the treatment of Retinitis Pigmentosa. Stem Cell Investig. 2018 Jun 6;5:18. doi: 10.21037/sci.2018.04.02. eCollection 2018.
Results Reference
result
PubMed Identifier
31119146
Citation
Weiss JN, Levy S. Dynamic light scattering spectroscopy of the retina-a non-invasive quantitative technique to objectively document visual improvement following ocular stem cell treatment. Stem Cell Investig. 2019 Apr 1;6:8. doi: 10.21037/sci.2019.03.01. eCollection 2019.
Results Reference
result
PubMed Identifier
31620478
Citation
Weiss JN, Levy S. Stem Cell Ophthalmology Treatment Study (SCOTS): bone marrow derived stem cells in the treatment of Usher syndrome. Stem Cell Investig. 2019 Sep 9;6:31. doi: 10.21037/sci.2019.08.07. eCollection 2019.
Results Reference
result
PubMed Identifier
32039263
Citation
Weiss JN, Levy S. Stem Cell Ophthalmology Treatment Study (SCOTS): bone marrow derived stem cells in the treatment of Dominant Optic Atrophy. Stem Cell Investig. 2019 Dec 5;6:41. doi: 10.21037/sci.2019.11.01. eCollection 2019.
Results Reference
result
PubMed Identifier
32231088
Citation
Weiss JN, Levy S. Stem Cell Ophthalmology Treatment Study (SCOTS): Bone Marrow-Derived Stem Cells in the Treatment of Age-Related Macular Degeneration. Medicines (Basel). 2020 Mar 28;7(4):16. doi: 10.3390/medicines7040016.
Results Reference
result
PubMed Identifier
33546345
Citation
Weiss JN, Levy S. Stem Cell Ophthalmology Treatment Study (SCOTS): Bone Marrow-Derived Stem Cells in the Treatment of Stargardt Disease. Medicines (Basel). 2021 Feb 3;8(2):10. doi: 10.3390/medicines8020010.
Results Reference
result
Links:
URL
http://www.mdstemcells.com/scots-ii/
Description
Study Information

Learn more about this trial

Stem Cell Ophthalmology Treatment Study II

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