Stem Cell Ophthalmology Treatment Study

Study Overview
=================
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/

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.

Official Title
-----------------
Bone Marrow Derived Stem Cell Ophthalmology Treatment Study

Conditions
-----------------
Retinal Disease, Macular Degeneration, Hereditary Retinal Dystrophy, Optic Nerve Disease, Glaucoma

Intervention / Treatment
-----------------
* Procedure: RB (Retrobulbar)
* Procedure: ST (Subtenon)
* Procedure: IV (Intravenous)
* Procedure: IVIT (Intravitreal)
* Procedure: IO (Intraocular)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RB, ST, IV<br>Injections of BMSC retrobulbar (RB), subtenon (ST) and intravenous (IV) | Procedure: RB (Retrobulbar)<br>* Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC)<br>* Other names: Retrobulbar injection of stem cells;Procedure: ST (Subtenon)<br>* Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)<br>* Other names: Subtenon injection of stem cells;Procedure: IV (Intravenous)<br>* Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)<br>* Other names: Intravenous injection of stem cells;|
| Active Comparator: RB, ST, IV, IVIT<br>Injections of BMSC retrobulbar, subtenon, intravenous and intravitreal ( IVIT ) | Procedure: RB (Retrobulbar)<br>* Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC)<br>* Other names: Retrobulbar injection of stem cells;Procedure: ST (Subtenon)<br>* Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)<br>* Other names: Subtenon injection of stem cells;Procedure: IV (Intravenous)<br>* Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)<br>* Other names: Intravenous injection of stem cells;Procedure: IVIT (Intravitreal)<br>* Intravitreal injection of Bone Marrow Derived Stem Cells (BMSC)<br>* Other names: Intravitreal injection of stem cells;|
| Active Comparator: RB, ST, IV, IO<br>Injection of BMSC retrobulbar, subtenon, intravenous and intraocular (IO) with vitrectomy | Procedure: RB (Retrobulbar)<br>* Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC)<br>* Other names: Retrobulbar injection of stem cells;Procedure: ST (Subtenon)<br>* Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)<br>* Other names: Subtenon injection of stem cells;Procedure: IV (Intravenous)<br>* Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)<br>* Other names: Intravenous injection of stem cells;Procedure: IO (Intraocular)<br>* 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.<br>* 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cone Dystrophy, Cone Rod Dystrophy, Maculopathy, Optic Nerve Disease, Optic Nerve Atrophy, Optic Atrophy, Ischemic Optic Neuropathy, Optic Nerve Damage, Optic Nerve Compression, Compressive Optic Neuropathy, Devics Syndrome, 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, Hereditary Retinal Dystrophy, Retinitis Pigmentosa, Stargardt Disease