<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03011541</url>
  </required_header>
  <id_info>
    <org_study_id>SCOTS2</org_study_id>
    <nct_id>NCT03011541</nct_id>
  </id_info>
  <brief_title>Stem Cell Ophthalmology Treatment Study II</brief_title>
  <acronym>SCOTS2</acronym>
  <official_title>Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MD Stem Cells</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MD Stem Cells</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the use of autologous bone marrow derived stem cells (BMSC) for the&#xD;
      treatment of retinal and optic nerve damage or disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eyes with loss of vision from retinal or optic nerve conditions generally considered&#xD;
      irreversible will be treated with a combination of injections of autologous bone marrow&#xD;
      derived stem cells isolated from the bone marrow using standard medical and surgical&#xD;
      practices. Retinal conditions may include degenerative, ischemic or physical damage (&#xD;
      examples may include macular degeneration, hereditary retinal dystrophies such as retinitis&#xD;
      pigmentosa, stargardt, non-perfusion retinopathies, post retinal detachment. Optic Nerve&#xD;
      conditions may include degenerative, ischemic or physical damage ( examples may include optic&#xD;
      nerve damage from glaucoma, compression, ischemic optic neuropathy, optic atrophy ).&#xD;
      Injections may include retrobulbar, subtenon, intravitreal, intraocular, subretinal and&#xD;
      intravenous. Patients will be followed for 12 months with serial comprehensive eye&#xD;
      examinations including relevant imaging and diagnostic ophthalmic testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Anticipated">July 2025</completion_date>
  <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single Arm- Arm 1. Comparator is natural history of the disease.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Acuity</measure>
    <time_frame>Change from pre-procedure to 12 months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Fields</measure>
    <time_frame>Change from pre-procedure to 12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical Coherence Tomography (OCT)</measure>
    <time_frame>Change from pre-procedure to 12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Retinal Disease</condition>
  <condition>Age-Related Macular Degeneration</condition>
  <condition>Retinitis Pigmentosa</condition>
  <condition>Stargardt Disease</condition>
  <condition>Optic Neuropathy</condition>
  <condition>Nonarteritic Ischemic Optic Neuropathy</condition>
  <condition>Optic Atrophy</condition>
  <condition>Optic Nerve Disease</condition>
  <condition>Glaucoma</condition>
  <condition>Leber Hereditary Optic Neuropathy</condition>
  <condition>Blindness</condition>
  <condition>Vision Loss Night</condition>
  <condition>Vision Loss Partial</condition>
  <condition>Vision, Low</condition>
  <condition>Retinopathy</condition>
  <condition>Maculopathy</condition>
  <condition>Macular Degeneration</condition>
  <condition>Retina Atrophy</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>BMSC provided retrobulbar, subtenon and intravenous for one or both eyes</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arm 1</intervention_name>
    <description>Procedure/ Surgery: RB (Retrobulbar)&#xD;
Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC)&#xD;
Procedure/Surgery: ST (Subtenon)&#xD;
Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)&#xD;
Procedure/Surgery: IV (Intravenous)&#xD;
Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)</description>
    <arm_group_label>Arm 1</arm_group_label>
    <other_name>Retrobulbar( RB)</other_name>
    <other_name>Subtenon (ST)</other_name>
    <other_name>Intravenous (IV)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have objective, documented damage to the retina or optic nerve unlikely to improve OR&#xD;
&#xD;
          -  Have objective, documented damage to the retina or optic nerve that is progressive AND&#xD;
             have less than or equal to 20/30 best corrected central visual acuity in one or both&#xD;
             eyes AND/OR an abnormal visual field in one or both eyes.&#xD;
&#xD;
          -  Be at least 3 months post-surgical treatment intended to treat any ophthalmologic&#xD;
             disease and stable.&#xD;
&#xD;
          -  If under current medical therapy ( pharmacologic treatment) for a retinal or optic&#xD;
             nerve disease be considered stable on that treatment and unlikely to have visual&#xD;
             function improvement ( for example, glaucoma with intraocular pressure stable on&#xD;
             topical medications but visual field damage ).&#xD;
&#xD;
          -  Have the potential for improvement with BMSC treatment and be at minimal risk of any&#xD;
             potential harm from the procedure.&#xD;
&#xD;
          -  Be over the age of 18&#xD;
&#xD;
          -  Be medically stable and able to be medically cleared by their primary care physician&#xD;
             or a licensed primary care practitioner for the procedure.&#xD;
&#xD;
          -  Medical clearance means that in the estimation of the primary care practitioner, the&#xD;
             patient can reasonably be expected to undergo the procedure without significant&#xD;
             medical risk to health.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are not capable of an adequate ophthalmologic examination or evaluation&#xD;
             to document the pathology.&#xD;
&#xD;
          -  Patients who are not capable or not willing to undergo follow up eye exams with the&#xD;
             principle investigator or their ophthalmologist or optometrist as outlined in the&#xD;
             protocol.&#xD;
&#xD;
          -  Patients who are not capable of providing informed consent.&#xD;
&#xD;
          -  Patients who may be at significant risk to general health or to the eyes and visual&#xD;
             function should they undergo the procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven Levy, MD</last_name>
    <role>Study Chair</role>
    <affiliation>MD Stem Cells</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeffrey Weiss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Coral Springs</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Steven Levy, MD</last_name>
    <phone>203-423-9494</phone>
    <email>stevenlevy@mdstemcells.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Steven Levy, MD</last_name>
    <phone>203-423-9494</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>MD Stem Cells</name>
      <address>
        <city>Westport</city>
        <state>Connecticut</state>
        <zip>06880</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Steven Levy, MD</last_name>
      <phone>203-423-9494</phone>
      <email>stevenlevy@mdstemcells.com</email>
    </contact>
    <contact_backup>
      <last_name>Steven Levy, MD</last_name>
      <phone>203-423-9494</phone>
    </contact_backup>
    <investigator>
      <last_name>Steven Levy, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jeffrey Weiss, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MD Stem Cells</name>
      <address>
        <city>Coral Springs</city>
        <state>Florida</state>
        <zip>33065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Steven Levy, MD</last_name>
      <phone>203-423-9494</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medcare Orthopaedics &amp; Spine Hospital</name>
      <address>
        <city>Dubai</city>
        <country>United Arab Emirates</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Steven Levy, MD</last_name>
      <phone>(001) 2034239494</phone>
    </contact>
  </location>
  <location_countries>
    <country>United Arab Emirates</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdstemcells.com/scots-ii/</url>
    <description>Study Information</description>
  </link>
  <results_reference>
    <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.</citation>
    <PMID>26199618</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>26604914</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>27857759</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>27904503</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>29270420</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>30050918</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>31119146</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>31620478</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>32039263</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>32231088</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>33546345</PMID>
  </results_reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 1, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>June 5, 2023</last_update_submitted>
  <last_update_submitted_qc>June 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stem Cells</keyword>
  <keyword>Bone Marrow Derived Stem Cells</keyword>
  <keyword>BMSC</keyword>
  <keyword>Mesenchymal Stem Cells</keyword>
  <keyword>MSC</keyword>
  <keyword>Eye Disease</keyword>
  <keyword>Ophthalmology</keyword>
  <keyword>Ophthalmic Disease</keyword>
  <keyword>Retina</keyword>
  <keyword>Retinal Disease</keyword>
  <keyword>Macular Degeneration</keyword>
  <keyword>Age Related Macular Degeneration</keyword>
  <keyword>Myopic Macular Degeneration</keyword>
  <keyword>Geographic Atrophy</keyword>
  <keyword>Dry Macular Degeneration</keyword>
  <keyword>Wet Macular Degeneration</keyword>
  <keyword>Retinal Atrophy</keyword>
  <keyword>Retinal Dystrophy</keyword>
  <keyword>Hereditary Retinal Dystrophy</keyword>
  <keyword>Malattia Leventinese</keyword>
  <keyword>Retinitis Pigmentosa</keyword>
  <keyword>Stargardt Disease</keyword>
  <keyword>Cone Dystrophy</keyword>
  <keyword>Rod-Cone Dystrophy</keyword>
  <keyword>Cone-Rod Dystrophy</keyword>
  <keyword>Maculopathy</keyword>
  <keyword>Optic Nerve Disease</keyword>
  <keyword>Optic Atrophy</keyword>
  <keyword>Optic Neuropathy</keyword>
  <keyword>Ischemic Optic Neuropathy</keyword>
  <keyword>Optic Nerve Damage</keyword>
  <keyword>Optic Nerve Compression</keyword>
  <keyword>Compressive Optic Neuropathy</keyword>
  <keyword>Devics Syndrome</keyword>
  <keyword>Ushers Syndrome</keyword>
  <keyword>Neuromyelitis Optica</keyword>
  <keyword>Dominant Optic Atrophy</keyword>
  <keyword>Kjers Optic Atrophy</keyword>
  <keyword>Leber Hereditary Optic Neuropathy</keyword>
  <keyword>Blindness</keyword>
  <keyword>Vision Loss</keyword>
  <keyword>Retina Atrophy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Optic Nerve Diseases</mesh_term>
    <mesh_term>Blindness</mesh_term>
    <mesh_term>Optic Neuropathy, Ischemic</mesh_term>
    <mesh_term>Optic Atrophy, Hereditary, Leber</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Optic Atrophy</mesh_term>
    <mesh_term>Vision, Low</mesh_term>
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Retinitis</mesh_term>
    <mesh_term>Retinitis Pigmentosa</mesh_term>
    <mesh_term>Stargardt Disease</mesh_term>
    <mesh_term>Atrophy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The investigators do not plan to share individual participant data (IPD)</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03011541
org study id: SCOTS2
nct id: NCT03011541
lead sponsor: 
has dmc: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single Arm- Arm 1. Comparator is natural history of the disease.
primary purpose: Treatment
masking: None (Open Label)
measure: Visual Acuity
time frame: Change from pre-procedure to 12 months
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.
measure: Visual Fields
time frame: Change from pre-procedure to 12 months
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.
measure: Optical Coherence Tomography (OCT)
time frame: Change from pre-procedure to 12 months
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.
arm group label: Arm 1
arm group type: Other
description: BMSC provided retrobulbar, subtenon and intravenous for one or both eyes
intervention type: Procedure
intervention name: Arm 1
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)
arm group label: Arm 1
other name: Retrobulbar( RB)
other name: Subtenon (ST)
other name: Intravenous (IV)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steven Levy, MD
role: Study Chair
affiliation: MD Stem Cells
last name: Jeffrey Weiss, MD
role: Principal Investigator
affiliation: Coral Springs
last name: Steven Levy, MD
phone: 203-423-9494
email: stevenlevy@mdstemcells.com
last name: Steven Levy, MD
phone: 203-423-9494
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United Arab Emirates
country: United States
url: http://www.mdstemcells.com/scots-ii/
description: Study Information
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.
PMID: 26199618
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.
PMID: 26604914
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.
PMID: 27857759
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.
PMID: 27904503
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.
PMID: 29270420
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.
PMID: 30050918
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.
PMID: 31119146
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.
PMID: 31620478
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.
PMID: 32039263
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.
PMID: 32231088
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.
PMID: 33546345
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases
mesh term: Optic Nerve Diseases
mesh term: Blindness
mesh term: Optic Neuropathy, Ischemic
mesh term: Optic Atrophy, Hereditary, Leber
mesh term: Nervous System Diseases
mesh term: Optic Atrophy
mesh term: Vision, Low
mesh term: Macular Degeneration
mesh term: Retinal Diseases
mesh term: Retinitis
mesh term: Retinitis Pigmentosa
mesh term: Stargardt Disease
mesh term: Atrophy
sharing ipd: No
ipd description: The investigators do not plan to share individual participant data (IPD)