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Stem Cell Ophthalmology Treatment Study (SCOTS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Retina Associates of South Florida
Sponsor:
Collaborator:
MD Stem Cells
Information provided by (Responsible Party):
Retina Associates of South Florida
ClinicalTrials.gov Identifier:
NCT01920867
First received: August 8, 2013
Last updated: December 18, 2016
Last verified: December 2016

August 8, 2013
December 18, 2016
August 2013
August 2017   (Final data collection date for primary outcome measure)
Visual acuity [ Time Frame: 1 day 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.
Visual acuity [ Time Frame: 1 day 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.
Complete list of historical versions of study NCT01920867 on ClinicalTrials.gov Archive Site
Visual fields [ Time Frame: 1 day 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.
Same as current
Not Provided
Not Provided
 
Stem Cell Ophthalmology Treatment Study
Bone Marrow Derived Stem Cell Ophthalmology Treatment Study
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.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Retinal Disease
  • Macular Degeneration
  • Hereditary Retinal Dystrophy
  • Optic Nerve Disease
  • Glaucoma
  • Procedure: RB (Retrobulbar)
    Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC)
    Other Name: Retrobulbar injection of stem cells
  • Procedure: ST (Subtenon)
    Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)
    Other Name: Subtenon injection of stem cells
  • Procedure: IV (Intravenous)
    Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)
    Other Name: Intravenous injection of stem cells
  • Procedure: IVIT (Intravitreal)
    Intravitreal injection of Bone Marrow Derived Stem Cells (BMSC)
    Other Name: Intravitreal injection of stem cells
  • Procedure: 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 Name: Intraocular injection of stem cells with vitrectomy
  • Active Comparator: RB, ST, IV
    Injections of BMSC retrobulbar (RB), subtenon (ST) and intravenous (IV)
    Interventions:
    • Procedure: RB (Retrobulbar)
    • Procedure: ST (Subtenon)
    • Procedure: IV (Intravenous)
  • Active Comparator: RB, ST, IV, IVIT
    Injections of BMSC retrobulbar, subtenon, intravenous and intravitreal ( IVIT )
    Interventions:
    • Procedure: RB (Retrobulbar)
    • Procedure: ST (Subtenon)
    • Procedure: IV (Intravenous)
    • Procedure: IVIT (Intravitreal)
  • Active Comparator: RB, ST, IV, IO
    Injection of BMSC retrobulbar, subtenon, intravenous and intraocular (IO) with vitrectomy
    Interventions:
    • Procedure: RB (Retrobulbar)
    • Procedure: ST (Subtenon)
    • Procedure: IV (Intravenous)
    • Procedure: IO (Intraocular)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
August 2017
August 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Steven Levy, MD 203-423-9494 stevenlevy@mdstemcells.com
United States,   United Arab Emirates
 
 
NCT01920867
ICMS-2013-0019.
Yes
Not Provided
No
Not Provided
Retina Associates of South Florida
Retina Associates of South Florida
MD Stem Cells
Principal Investigator: Jeffrey Weiss, MD Retina Associates of South Florida
Study Director: Steven Levy, MD MD Stem Cells
Retina Associates of South Florida
December 2016

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