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Stem Cell Ophthalmology Treatment Study II (SCOTS2)

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ClinicalTrials.gov Identifier: NCT03011541
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
MD Stem Cells

Tracking Information
First Submitted Date  ICMJE January 1, 2017
First Posted Date  ICMJE January 5, 2017
Last Update Posted Date June 3, 2019
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03011541 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stem Cell Ophthalmology Treatment Study II
Official Title  ICMJE Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Active Comparator: Arm 1
    BMSC provided retrobulbar, subtenon and intravenous for one or both eyes
    Intervention: Procedure: Arm 1
  • Active Comparator: Arm 2
    BMSC provided retrobulbar, subtenon, intravitreal and intravenous for one or both eyes
    Intervention: Procedure: Arm 2
  • 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.
    Interventions:
    • Procedure: Arm 1
    • Procedure: Arm 2
    • Procedure: Arm 3
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 3, 2017)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Steven Levy, MD 203-423-9494 stevenlevy@mdstemcells.com
Listed Location Countries  ICMJE United Arab Emirates,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03011541
Other Study ID Numbers  ICMJE SCOTS2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The investigators do not plan to share individual participant data (IPD)
Responsible Party MD Stem Cells
Study Sponsor  ICMJE MD Stem Cells
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Steven Levy, MD MD Stem Cells
Principal Investigator: Jeffrey N Weiss, MD The Healing Institute
PRS Account MD Stem Cells
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP