Stem Cell Ophthalmology Treatment Study (SCOTS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 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: March 24, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Retinal Disease
Macular Degeneration
Hereditary Retinal Dystrophy
Optic Nerve Disease
Glaucoma
Procedure: RB (Retrobulbar)
Procedure: ST (Subtenon)
Procedure: IV (Intravenous)
Procedure: IVIT (Intravitreal)
Procedure: IO (Intraocular)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bone Marrow Derived Stem Cell Ophthalmology Treatment Study

Resource links provided by NLM:


Further study details as provided by Retina Associates of South Florida:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 1 day to 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 day to 12 months ] [ Designated as safety issue: No ]
    Visual fields will be evaluated with automated perimetry during post- procedure visits as needed and specifically at 6 months and 12 months.


Estimated Enrollment: 300
Study Start Date: August 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RB, ST, IV
Injections of BMSC retrobulbar (RB), subtenon (ST) and intravenous (IV)
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
Active Comparator: RB, ST, IV, IVIT
Injections of BMSC retrobulbar, subtenon, intravenous and intravitreal (IVIT)
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
Active Comparator: RB, ST, IV, IO
Injection of BMSC retrobulbar, subtenon, intravenous and intraocular (IO) with vitrectomy
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: 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 or subretinal injections of stem cells.
Other Name: Intraocular injection of stem cells with vitrectomy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01920867

Contacts
Contact: Steven Levy, MD 203-423-9494 info@mdstemcells.com

Locations
United States, Florida
Retina Associates of South Florida Recruiting
Margate, Florida, United States, 33063
Contact: Steven Levy, MD    203-423-9494    info@mdstemcells.com   
Principal Investigator: Jeffrey Weiss, MD         
Sub-Investigator: Steven Levy, MD         
United Arab Emirates
Al Zahra Private Hospital Recruiting
Dubai, UAE, United Arab Emirates
Contact: Steven Levy, MD    (001) 203-423-9494    info@mdstemcells.com   
Principal Investigator: Jeffrey Weiss, MD         
Sponsors and Collaborators
Retina Associates of South Florida
MD Stem Cells
Investigators
Principal Investigator: Jeffrey Weiss, MD Retina Associates of South Florida
Study Director: Steven Levy, MD MD Stem Cells
  More Information

No publications provided

Responsible Party: Retina Associates of South Florida
ClinicalTrials.gov Identifier: NCT01920867     History of Changes
Other Study ID Numbers: ICMS-2013-0019.
Study First Received: August 8, 2013
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government
United States: Data and Safety Monitoring Board

Keywords provided by Retina Associates of South Florida:
Devics Syndrome
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

Additional relevant MeSH terms:
Macular Degeneration
Retinal Diseases
Optic Nerve Diseases
Retinal Dystrophies
Nervous System Diseases
Retinal Degeneration
Eye Diseases
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on October 19, 2014