Stem Cell Ophthalmology Treatment Study (SCOTS)

October 21, 2019 updated by: MD Stem Cells

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. http://mdstemcells.com/scots-ii/

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Westport, Connecticut, United States, 06880
        • MD Stem Cells

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Retrobulbar injection of stem cells
Procedure: ST (Subtenon)
Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)
Other Names:
  • Subtenon injection of stem cells
Procedure: IV (Intravenous)
Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)
Other Names:
  • 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 Names:
  • Retrobulbar injection of stem cells
Procedure: ST (Subtenon)
Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)
Other Names:
  • Subtenon injection of stem cells
Procedure: IV (Intravenous)
Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)
Other Names:
  • Intravenous injection of stem cells
Procedure: IVIT (Intravitreal)
Intravitreal injection of Bone Marrow Derived Stem Cells (BMSC)
Other Names:
  • 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 Names:
  • Retrobulbar injection of stem cells
Procedure: ST (Subtenon)
Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)
Other Names:
  • Subtenon injection of stem cells
Procedure: IV (Intravenous)
Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)
Other Names:
  • 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, intraneuronal injections or subretinal injections of stem cells.
Other Names:
  • Intraocular injection of stem cells with vitrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MD Stem Cells

Investigators

  • Study Director: Steven Levy, MD, MD Stem Cells
  • Principal Investigator: Jeffrey Weiss, MD, MD Stem Cells

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

August 9, 2013

First Posted (Estimate)

August 12, 2013

Study Record Updates

Last Update Posted (Actual)

October 23, 2019

Last Update Submitted That Met QC Criteria

October 21, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICMS-2013-0019.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Study Data/Documents

  1. Clinical Study Report
    Information comments: http://mdstemcells.com/scots-ii/

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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