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 — PROCEDURE
    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)

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 1
    BMSC 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

Locations (2)

FacilityCityStateZIPSite coordinators
MD Stem CellsWestportConnecticut06880
Steven Levy, MD
203-423-9494
Steven Levy, MD
203-423-9494
Steven Levy, MD (SUB_INVESTIGATOR)
Jeffrey Weiss, MD (PRINCIPAL_INVESTIGATOR)
MD Stem CellsCoral SpringsFlorida33065
Steven Levy, MD
203-423-9494

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