Trials / Recruiting
RecruitingNCT03011541
Stem Cell Ophthalmology Treatment Study II
Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- 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.
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
- Age-Related Macular Degeneration
- Retinitis Pigmentosa
- Stargardt Disease
- Optic Neuropathy
- Nonarteritic Ischemic Optic Neuropathy
- Optic Atrophy
- Optic Nerve Disease
- Glaucoma
- Leber Hereditary Optic Neuropathy
- Blindness
- Vision Loss Night
- Vision Loss Partial
- Vision, Low
- Retinopathy
- Maculopathy
- Macular Degeneration
- Retina Atrophy
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2026-07-31
- Completion
- 2027-07-31
- First posted
- 2017-01-05
- Last updated
- 2025-03-20
Locations
4 sites across 3 countries: United States, Austria, United Arab Emirates
Source: ClinicalTrials.gov record NCT03011541. Inclusion in this directory is not an endorsement.