Recruiting

Stem Cell Ophthalmology

Sponsor:

MD Stem Cells

Code:

NCT03011541

Conditions

Retinal Disease

Age-Related Macular Degeneration

Retinitis Pigmentosa

Stargardt Disease

Optic Neuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Arm 1

Study Details

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.

Conditions

Retinal Disease

Age-Related Macular Degeneration

Retinitis Pigmentosa

Stargardt Disease

Optic Neuropathy

Study ID

NCT03011541

Start date

Jan, 2016

Status verified date

Jun, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 20/30 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

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Arm 1

BMSC provided retrobulbar, subtenon and intravenous for one or both eyes

Interventions

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)

Primary outcome measure

  • Visual Acuity [ Time Frame: Change from pre-procedure to 12 months ]

Central Contacts and Locations

Central contacts

Steven Levy, MD

203-423-9494stevenlevy@mdstemcells.com

Steven Levy, MD

203-423-9494

Locations

MD Stem Cells

Recruiting

Westport, Connecticut, United States, 06880

Contacts

Steven Levy, MD

203-423-9494stevenlevy@mdstemcells.com

Steven Levy, MD

203-423-9494

Principal Investigator:

Jeffrey Weiss, MD

MD Stem Cells

Recruiting

Coral Springs, Florida, United States, 33065

Contacts

Steven Levy, MD

203-423-9494

More Information

Sponsor

MD Stem Cells

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • Stem Cells
  • Bone Marrow Derived Stem Cells
  • BMSC
  • Mesenchymal Stem Cells
  • MSC
  • Eye Disease
  • Ophthalmology
  • Ophthalmic Disease
  • Retina
  • Retinal Disease
  • Macular Degeneration
  • Age Related Macular Degeneration
  • Myopic Macular Degeneration
  • Geographic Atrophy
  • Dry Macular Degeneration
  • Wet Macular Degeneration
  • Retinal Atrophy
  • Retinal Dystrophy
  • Hereditary Retinal Dystrophy
  • Malattia Leventinese
  • Retinitis Pigmentosa
  • Stargardt Disease
  • Cone Dystrophy
  • Rod-Cone Dystrophy
  • Cone-Rod Dystrophy
  • Maculopathy
  • Optic Nerve Disease
  • Optic Atrophy
  • Optic Neuropathy
  • Ischemic Optic Neuropathy
  • Optic Nerve Damage
  • Optic Nerve Compression
  • Compressive Optic Neuropathy
  • Devics Syndrome
  • Ushers Syndrome
  • Neuromyelitis Optica
  • Dominant Optic Atrophy
  • Kjers Optic Atrophy
  • Leber Hereditary Optic Neuropathy
  • Blindness
  • Vision Loss
  • Retina Atrophy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by MD Stem Cells on 2026-06-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.