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Stem Cell Ophthalmology Treatment Study (SCOTS)

Primary Purpose

Retinal Disease, Macular Degeneration, Hereditary Retinal Dystrophy

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RB (Retrobulbar)
ST (Subtenon)
IV (Intravenous)
IVIT (Intravitreal)
IO (Intraocular)
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, BMC (Bone Marrow Cell), Mesenchymal Stem Cells, MSC, Eye Disease, Eye Stem Cells, 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, Retinitis Pigmentosa, Stargardt Disease, Cone Dystrophy, Cone Rod Dystrophy, Maculopathy, Optic Nerve Disease, Optic Nerve Atrophy, Optic Atrophy, Ischemic Optic Neuropathy, Optic Nerve Damage, Optic Nerve Compression, Compressive Optic Neuropathy, Devics Syndrome

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 20/40 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.

Sites / Locations

  • MD Stem Cells

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

RB, ST, IV

RB, ST, IV, IVIT

RB, ST, IV, IO

Arm Description

Injections of BMSC retrobulbar (RB), subtenon (ST) and intravenous (IV)

Injections of BMSC retrobulbar, subtenon, intravenous and intravitreal ( IVIT )

Injection of BMSC retrobulbar, subtenon, intravenous and intraocular (IO) with vitrectomy

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.

Full Information

First Posted
August 8, 2013
Last Updated
October 21, 2019
Sponsor
MD Stem Cells
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1. Study Identification

Unique Protocol Identification Number
NCT01920867
Brief Title
Stem Cell Ophthalmology Treatment Study
Acronym
SCOTS
Official Title
Bone Marrow Derived Stem Cell Ophthalmology Treatment Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

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. http://mdstemcells.com/scots-ii/
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, Macular Degeneration, Hereditary Retinal Dystrophy, Optic Nerve Disease, Glaucoma
Keywords
Stem Cells, Bone Marrow Derived Stem Cells, BMSC, BMC (Bone Marrow Cell), Mesenchymal Stem Cells, MSC, Eye Disease, Eye Stem Cells, 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, Retinitis Pigmentosa, Stargardt Disease, Cone Dystrophy, Cone Rod Dystrophy, Maculopathy, Optic Nerve Disease, Optic Nerve Atrophy, Optic Atrophy, Ischemic Optic Neuropathy, Optic Nerve Damage, Optic Nerve Compression, Compressive Optic Neuropathy, Devics Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RB, ST, IV
Arm Type
Active Comparator
Arm Description
Injections of BMSC retrobulbar (RB), subtenon (ST) and intravenous (IV)
Arm Title
RB, ST, IV, IVIT
Arm Type
Active Comparator
Arm Description
Injections of BMSC retrobulbar, subtenon, intravenous and intravitreal ( IVIT )
Arm Title
RB, ST, IV, IO
Arm Type
Active Comparator
Arm Description
Injection of BMSC retrobulbar, subtenon, intravenous and intraocular (IO) with vitrectomy
Intervention Type
Procedure
Intervention Name(s)
RB (Retrobulbar)
Other Intervention Name(s)
Retrobulbar injection of stem cells
Intervention Description
Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC)
Intervention Type
Procedure
Intervention Name(s)
ST (Subtenon)
Other Intervention Name(s)
Subtenon injection of stem cells
Intervention Description
Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)
Intervention Type
Procedure
Intervention Name(s)
IV (Intravenous)
Other Intervention Name(s)
Intravenous injection of stem cells
Intervention Description
Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)
Intervention Type
Procedure
Intervention Name(s)
IVIT (Intravitreal)
Other Intervention Name(s)
Intravitreal injection of stem cells
Intervention Description
Intravitreal injection of Bone Marrow Derived Stem Cells (BMSC)
Intervention Type
Procedure
Intervention Name(s)
IO (Intraocular)
Other Intervention Name(s)
Intraocular injection of stem cells with vitrectomy
Intervention Description
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.
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
1 day 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.
Time Frame
1 day 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 20/40 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Levy, MD
Organizational Affiliation
MD Stem Cells
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jeffrey Weiss, MD
Organizational Affiliation
MD Stem Cells
Official's Role
Principal Investigator
Facility Information:
Facility Name
MD Stem Cells
City
Westport
State/Province
Connecticut
ZIP/Postal Code
06880
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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
32568958
Citation
Kasetty MA, Hedges TR 3rd, Witkin AJ. BILATERAL EPIRETINAL MEMBRANE FORMATION AFTER INTRAVITREAL INJECTIONS OF AUTOLOGOUS MESENCHYMAL STEM CELLS. Retin Cases Brief Rep. 2022 Sep 1;16(5):561-564. doi: 10.1097/ICB.0000000000001032.
Results Reference
derived
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
derived
Links:
URL
https://mdstemcells.com
Description
The Role of Patient Funded Clinical Research in Advancing Medical Care
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
http://mdstemcells.com/scots-ii/
Available IPD/Information Comments
http://mdstemcells.com/scots-ii/

Learn more about this trial

Stem Cell Ophthalmology Treatment Study

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