An interventional study of RB (Retrobulbar) and ST (Subtenon) in Retinal Disease, Macular Degeneration and Hereditary Retinal Dystrophy, sponsored by MD Stem Cells. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-23.
Sponsored by MD Stem Cells · Not applicable, Interventional, and Treatment
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/
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.
333 studies on the registry are indexed under Retinal Diseases; 60 are open to participants now.
This study's enrollment of 300 is above the median of 52 across 207 interventional studies indexed under Retinal Diseases.
Browse Retinal Diseases studies →MD Stem Cells is the lead sponsor of 6 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Injections of BMSC retrobulbar (RB), subtenon (ST) and intravenous (IV)
Procedure: RB (Retrobulbar) · Procedure: ST (Subtenon) · Procedure: IV (Intravenous)
Injections of BMSC retrobulbar, subtenon, intravenous and intravitreal ( IVIT )
Procedure: RB (Retrobulbar) · Procedure: ST (Subtenon) · Procedure: IV (Intravenous) · Procedure: IVIT (Intravitreal)
Injection of BMSC retrobulbar, subtenon, intravenous and intraocular (IO) with vitrectomy
Procedure: RB (Retrobulbar) · Procedure: ST (Subtenon) · Procedure: IV (Intravenous) · Procedure: IO (Intraocular)
Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC)
Also known as: Retrobulbar injection of stem cells
Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)
Also known as: Subtenon injection of stem cells
Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)
Also known as: Intravenous injection of stem cells
Intravitreal injection of Bone Marrow Derived Stem Cells (BMSC)
Also known as: Intravitreal injection of stem cells
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.
Also known as: Intraocular injection of stem cells with vitrectomy
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.
Time frame: 1 day to 12 months
Visual fields
Visual fields will be evaluated with automated perimetry during post- procedure visits as needed and specifically at 6 months and 12 months.
Time frame: 1 day to 12 months
Plan to share: No
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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