Stem Cell Ophthalmology Treatment Study II (SCOTS2)
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ClinicalTrials.gov Identifier: NCT03011541 |
Recruitment Status :
Recruiting
First Posted : January 5, 2017
Last Update Posted : April 16, 2024
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Sponsor:
MD Stem Cells
Information provided by (Responsible Party):
MD Stem Cells
Tracking Information | |||||||||
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First Submitted Date ICMJE | January 1, 2017 | ||||||||
First Posted Date ICMJE | January 5, 2017 | ||||||||
Last Update Posted Date | April 16, 2024 | ||||||||
Actual Study Start Date ICMJE | January 2016 | ||||||||
Estimated Primary Completion Date | July 31, 2025 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Visual Acuity [ Time Frame: Change from pre-procedure 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Stem Cell Ophthalmology Treatment Study II | ||||||||
Official Title ICMJE | Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II | ||||||||
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. | ||||||||
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 ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Single Arm- Arm 1. Comparator is natural history of the disease. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Procedure: Arm 1
Procedure/ Surgery: RB (Retrobulbar) Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC) Procedure/Surgery: ST (Subtenon) Subtenon injection of Bone Marrow Derived Stem Cells (BMSC) Procedure/Surgery: IV (Intravenous) Intravenous injection of Bone Marrow Derived Stem Cells (BMSC) Other Names:
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Study Arms ICMJE | Arm 1
BMSC provided retrobulbar, subtenon and intravenous for one or both eyes
Intervention: Procedure: Arm 1
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
500 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | July 31, 2026 | ||||||||
Estimated Primary Completion Date | July 31, 2025 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United Arab Emirates, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03011541 | ||||||||
Other Study ID Numbers ICMJE | SCOTS2 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||
IPD Sharing Statement ICMJE |
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Current Responsible Party | MD Stem Cells | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | MD Stem Cells | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | MD Stem Cells | ||||||||
Verification Date | April 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |