RECRUITING

Stem Cell Ophthalmology Treatment Study II

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Conditions

Retinal DiseaseAge-Related Macular DegenerationRetinitis PigmentosaStargardt DiseaseOptic NeuropathyNonarteritic Ischemic Optic NeuropathyOptic AtrophyOptic Nerve DiseaseGlaucomaLeber Hereditary Optic NeuropathyBlindnessVision Loss NightVision Loss PartialVision, LowRetinopathyMaculopathyMacular DegenerationRetina AtrophyStem CellsBone Marrow Derived Stem CellsBMSCMesenchymal Stem CellsMSCEye DiseaseOphthalmologyOphthalmic DiseaseRetinaAge Related Macular DegenerationMyopic Macular DegenerationGeographic AtrophyDry Macular DegenerationWet Macular DegenerationRetinal AtrophyRetinal DystrophyHereditary Retinal DystrophyMalattia LeventineseCone DystrophyRod-Cone DystrophyCone-Rod DystrophyIschemic Optic NeuropathyOptic Nerve DamageOptic Nerve CompressionCompressive Optic NeuropathyDevics SyndromeUshers SyndromeNeuromyelitis OpticaDominant Optic AtrophyKjers Optic AtrophyVision Loss

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II

Quick Facts

Study Start:2016-01
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03011541

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have objective, documented damage to the retina or optic nerve unlikely to improve OR
  2. * 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.
  3. * Be at least 3 months post-surgical treatment intended to treat any ophthalmologic disease and stable.
  4. * 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 ).
  5. * Have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.
  6. * Be over the age of 18
  7. * Be medically stable and able to be medically cleared by their primary care physician or a licensed primary care practitioner for the procedure.
  8. * 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.
  1. * Patients who are not capable of an adequate ophthalmologic examination or evaluation to document the pathology.
  2. * 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.
  3. * Patients who are not capable of providing informed consent.
  4. * Patients who may be at significant risk to general health or to the eyes and visual function should they undergo the procedure.

Contacts and Locations

Study Contact

Steven Levy, MD
CONTACT
203-423-9494
stevenlevy@mdstemcells.com
Steven Levy, MD
CONTACT
203-423-9494

Principal Investigator

Steven Levy, MD
STUDY_CHAIR
MD Stem Cells
Jeffrey Weiss, MD
PRINCIPAL_INVESTIGATOR
Coral Springs

Study Locations (Sites)

MD Stem Cells
Westport, Connecticut, 06880
United States
MD Stem Cells
Coral Springs, Florida, 33065
United States

Collaborators and Investigators

Sponsor: MD Stem Cells

  • Steven Levy, MD, STUDY_CHAIR, MD Stem Cells
  • Jeffrey Weiss, MD, PRINCIPAL_INVESTIGATOR, Coral Springs

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-01
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2016-01
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • 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