NCT01920867

Stem Cell Ophthalmology Treatment Study

Bone Marrow Derived Stem Cell Ophthalmology Treatment Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: MD Stem Cells · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Retinal Disease
• Macular Degeneration
• Hereditary Retinal Dystrophy
• Optic Nerve Disease
• Glaucoma

Interventions

Type	Name	Description
PROCEDURE	RB (Retrobulbar)	Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC)
PROCEDURE	ST (Subtenon)	Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)
PROCEDURE	IV (Intravenous)	Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)
PROCEDURE	IVIT (Intravitreal)	Intravitreal injection of Bone Marrow Derived Stem Cells (BMSC)
PROCEDURE	IO (Intraocular)	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.

Timeline

• Start date: 2012-08-01
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2013-08-12
• Last updated: 2019-10-23

Locations

1 site across 1 country: United States