Retinal DiseaseSCOTSNCT01920867
Stem Cell Ophthalmology Treatment Study
A study testing RB (Retrobulbar), ST (Subtenon) and IV (Intravenous) in people with Retinal Disease and Macular Degeneration, run by MD Stem Cells at 1 site in United States.
Trial 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/ Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Disease, Macular Degeneration, Hereditary Retinal Dystrophy
- What is being tested?
- RB (Retrobulbar), ST (Subtenon) and IV (Intravenous)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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/
Read the 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.
- Conditions
- Retinal Disease, Macular Degeneration, Hereditary Retinal Dystrophy, Optic Nerve Disease, Glaucoma
- Being tested
- RB (Retrobulbar), ST (Subtenon), IV (Intravenous), IVIT (Intravitreal), IO (Intraocular)
- Keywords
- 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
- Medical subject headings
- Retinal Diseases, Macular Degeneration, Optic Nerve Diseases, Glaucoma, Eye Diseases, Geographic Atrophy, Wet Macular Degeneration, Retinal Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RB (Retrobulbar)Procedure or surgery
Also called Retrobulbar injection of stem cells
Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC)
ST (Subtenon)Procedure or surgery
Also called Subtenon injection of stem cells
Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)
IV (Intravenous)Procedure or surgery
Also called Intravenous injection of stem cells
Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)
IVIT (Intravitreal)Procedure or surgery
Also called Intravitreal injection of stem cells
Intravitreal injection of Bone Marrow Derived Stem Cells (BMSC)
IO (Intraocular)Procedure or surgery
Also called Intraocular injection of stem cells with vitrectomy
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.
| Study group | Role | What they receive |
|---|---|---|
| RB, ST, IV | Active comparator | Injections of BMSC retrobulbar (RB), subtenon (ST) and intravenous (IV) Receives: Procedure: RB (Retrobulbar); Procedure: ST (Subtenon); Procedure: IV (Intravenous) |
| RB, ST, IV, IVIT | Active comparator | Injections of BMSC retrobulbar, subtenon, intravenous and intravitreal ( IVIT ) Receives: Procedure: RB (Retrobulbar); Procedure: ST (Subtenon); Procedure: IV (Intravenous); Procedure: IVIT (Intravitreal) |
| RB, ST, IV, IO | Active comparator | Injection of BMSC retrobulbar, subtenon, intravenous and intraocular (IO) with vitrectomy Receives: Procedure: RB (Retrobulbar); Procedure: ST (Subtenon); Procedure: IV (Intravenous); Procedure: IO (Intraocular) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day to 12 months
Secondary outcomes (1)
Visual fields
Visual fields will be evaluated with automated perimetry during post- procedure visits as needed and specifically at 6 months and 12 months.
Measured: 1 day to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startAug 2012
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- MD Stem Cells
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Levy, MD, Study director, MD Stem CellsJeffrey Weiss, MD, Principal investigator, MD Stem Cells
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920867
- Sponsor's protocol ID
- ICMS-2013-0019.
- Acronym
- SCOTS
- Status last verified
- Oct 2019
- First submitted
- 8 Aug 2013
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26199618Weiss 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.
PubMed 26604914Weiss 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.
PubMed 27857759Kasetty 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.
PubMed 32568958Weiss 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.
PubMed 27904503
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Derived Stem Cell Ophthalmology Treatment Study
- ClinicalTrials.gov ID
- NCT01920867
- Acronym / sponsor ID
- SCOTS / ICMS-2013-0019.
- Conditions
- Retinal Disease, Macular Degeneration, Hereditary Retinal Dystrophy, Optic Nerve Disease, Glaucoma
- Keywords
- Stem Cells, Bone Marrow Derived Stem Cells, BMSC, BMC (Bone Marrow Cell), Mesenchymal Stem Cells, MSC, Eye Disease, Eye Stem Cells
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- MD Stem CellsIndustry (pharma, biotech, devices)
- Study start
- Aug 2012 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 12 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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/
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RB, ST, IV | Active comparator | Procedure: RB (Retrobulbar), Procedure: ST (Subtenon), Procedure: IV (Intravenous)Injections of BMSC retrobulbar (RB), subtenon (ST) and intravenous (IV) |
| RB, ST, IV, IVIT | Active comparator | Procedure: RB (Retrobulbar), Procedure: ST (Subtenon), Procedure: IV (Intravenous), Procedure: IVIT (Intravitreal)Injections of BMSC retrobulbar, subtenon, intravenous and intravitreal ( IVIT ) |
| RB, ST, IV, IO | Active comparator | Procedure: RB (Retrobulbar), Procedure: ST (Subtenon), Procedure: IV (Intravenous), Procedure: IO (Intraocular)Injection of BMSC retrobulbar, subtenon, intravenous and intraocular (IO) with vitrectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 ).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RB (Retrobulbar)Also: Retrobulbar injection of stem cellsRetrobulbar injection of Bone Marrow Derived Stem Cells (BMSC) | Procedure or surgery | RB, ST, IV, RB, ST, IV, IO, RB, ST, IV, IVIT |
| ST (Subtenon)Also: Subtenon injection of stem cellsSubtenon injection of Bone Marrow Derived Stem Cells (BMSC) | Procedure or surgery | RB, ST, IV, RB, ST, IV, IO, RB, ST, IV, IVIT |
| IV (Intravenous)Also: Intravenous injection of stem cellsIntravenous injection of Bone Marrow Derived Stem Cells (BMSC) | Procedure or surgery | RB, ST, IV, RB, ST, IV, IO, RB, ST, IV, IVIT |
| IVIT (Intravitreal)Also: Intravitreal injection of stem cellsIntravitreal injection of Bone Marrow Derived Stem Cells (BMSC) | Procedure or surgery | RB, ST, IV, IVIT |
| IO (Intraocular)Also: Intraocular injection of stem cells with vitrectomyIntraocular 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. | Procedure or surgery | RB, ST, IV, IO |
Primary outcome
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 secondary outcome
Visual fields
Time frame: 1 day to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Results publication: PubMed 26199618Weiss 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.
- Results publication: PubMed 26604914Weiss 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.
- Results publication: PubMed 27857759Weiss 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.
- Derived from this study: PubMed 32568958Kasetty 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.
- Derived from this study: PubMed 27904503Weiss 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.
- The Role of Patient Funded Clinical Research in Advancing Medical CareLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Levy, MD study director
MD Stem Cells
Jeffrey Weiss, MD principal investigator
MD Stem Cells
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RB (Retrobulbar), ST (Subtenon) and IV (Intravenous) in people with Retinal Disease and Macular Degeneration, run by MD Stem Cells at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 1 day to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01920867, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.