Stem Cell Ophthalmology Treatment Study

Not Applicable

• Conditions: Retinal Disease; Optic Nerve Disease; Glaucoma; Hereditary Retinal Dystrophy; Macular Degeneration
• Interventions: Procedure: RB (Retrobulbar); Procedure: ST (Subtenon); Procedure: IV (Intravenous); Procedure: IO (Intraocular); Procedure: IVIT (Intravitreal)

• Registration Number: NCT01920867
• Lead Sponsor: MD Stem Cells

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-08-08
• Study First Submitted QC: 2013-08-09
• Study First Posted: 2013-08-12
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-23
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RB, ST, IV	IV (Intravenous)	Injections of BMSC retrobulbar (RB), subtenon (ST) and intravenous (IV)
RB, ST, IV	ST (Subtenon)	Injections of BMSC retrobulbar (RB), subtenon (ST) and intravenous (IV)
RB, ST, IV, IVIT	RB (Retrobulbar)	Injections of BMSC retrobulbar, subtenon, intravenous and intravitreal ( IVIT )
RB, ST, IV, IVIT	ST (Subtenon)	Injections of BMSC retrobulbar, subtenon, intravenous and intravitreal ( IVIT )
RB, ST, IV	RB (Retrobulbar)	Injections of BMSC retrobulbar (RB), subtenon (ST) and intravenous (IV)
RB, ST, IV, IO	IO (Intraocular)	Injection of BMSC retrobulbar, subtenon, intravenous and intraocular (IO) with vitrectomy
RB, ST, IV, IVIT	IV (Intravenous)	Injections of BMSC retrobulbar, subtenon, intravenous and intravitreal ( IVIT )
RB, ST, IV, IVIT	IVIT (Intravitreal)	Injections of BMSC retrobulbar, subtenon, intravenous and intravitreal ( IVIT )
RB, ST, IV, IO	RB (Retrobulbar)	Injection of BMSC retrobulbar, subtenon, intravenous and intraocular (IO) with vitrectomy
RB, ST, IV, IO	ST (Subtenon)	Injection of BMSC retrobulbar, subtenon, intravenous and intraocular (IO) with vitrectomy
RB, ST, IV, IO	IV (Intravenous)	Injection of BMSC retrobulbar, subtenon, intravenous and intraocular (IO) with vitrectomy

Primary Outcome Measures

Name	Time	Method
Visual acuity	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.

Secondary Outcome Measures

Name	Time	Method
Visual fields	1 day to 12 months	Visual fields will be evaluated with automated perimetry during post- procedure visits as needed and specifically at 6 months and 12 months.

Trial Locations

Locations (1)

MD Stem Cells; 🇺🇸 Westport, Connecticut, United States