Stem Cell Ophthalmology Treatment Study
SCOTS
Bone Marrow Derived Stem Cell Ophthalmology Treatment Study
1 other identifier
interventional
300
1 country
1
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. http://mdstemcells.com/scots-ii/
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 8, 2013
CompletedFirst Posted
Study publicly available on registry
August 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedOctober 23, 2019
October 1, 2019
7.9 years
August 8, 2013
October 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual acuity
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 Outcomes (1)
Visual fields
1 day to 12 months
Study Arms (3)
RB, ST, IV
ACTIVE COMPARATORInjections of BMSC retrobulbar (RB), subtenon (ST) and intravenous (IV)
RB, ST, IV, IVIT
ACTIVE COMPARATORInjections of BMSC retrobulbar, subtenon, intravenous and intravitreal ( IVIT )
RB, ST, IV, IO
ACTIVE COMPARATORInjection of BMSC retrobulbar, subtenon, intravenous and intraocular (IO) with vitrectomy
Interventions
Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC)
Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)
Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)
Intravitreal injection of Bone Marrow Derived Stem Cells (BMSC)
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MD Stem Cellslead
Study Sites (1)
MD Stem Cells
Westport, Connecticut, 06880, United States
Related Publications (5)
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: 26199618RESULTWeiss 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: 26604914RESULTWeiss 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: 27857759RESULTKasetty MA, Hedges TR 3rd, Witkin AJ. BILATERAL EPIRETINAL MEMBRANE FORMATION AFTER INTRAVITREAL INJECTIONS OF AUTOLOGOUS MESENCHYMAL STEM CELLS. Retin Cases Brief Rep. 2022 Sep 1;16(5):561-564. doi: 10.1097/ICB.0000000000001032.
PMID: 32568958DERIVEDWeiss 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: 27904503DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Steven Levy, MD
MD Stem Cells
- PRINCIPAL INVESTIGATOR
Jeffrey Weiss, MD
MD Stem Cells
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2013
First Posted
August 12, 2013
Study Start
August 1, 2012
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
October 23, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share