Stem Cell Ophthalmology Treatment Study II
Part of paid clinical trials in Westport, Connecticut.
- Sponsor
- MD Stem Cells
- Study ID
- NCT03011541
- Status
- Recruiting
Conditions
- Age-Related Macular Degeneration
- Blindness
- Glaucoma
- Leber Hereditary Optic Neuropathy
- Macular Degeneration
- Maculopathy
- Nonarteritic Ischemic Optic Neuropathy
- Optic Atrophy
- Optic Nerve Disease
- Optic Neuropathy
- Retina Atrophy
- Retinal Disease
- Retinitis Pigmentosa
- Retinopathy
- Stargardt Disease
- Vision Loss Night
- Vision Loss Partial
- Vision, Low
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Arm 1 — PROCEDUREProcedure/ 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)
Study Details
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.
Key Dates
- Start date
- Jan 31, 2016
- Status verified
- Mar 2025
- Primary completion
- Jul 31, 2026
- Completion
- Jul 31, 2027
Study Design
- Enrollment
- 500 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: Arm 1BMSC provided retrobulbar, subtenon and intravenous for one or both eyes
Primary Outcome Measure
Visual Acuity [ Time Frame: Change from pre-procedure to 12 months ]
Central Contacts
- Steven Levy, MD203-423-9494
- Steven Levy, MD203-423-9494
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| MD Stem Cells | Westport | Connecticut | 06880 | Steven Levy, MD 203-423-9494 Steven Levy, MD (SUB_INVESTIGATOR) Jeffrey Weiss, MD (PRINCIPAL_INVESTIGATOR) |
| MD Stem Cells | Coral Springs | Florida | 33065 | Steven Levy, MD 203-423-9494 |
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