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New treatment option for Retinal Disease
Official title Stem Cell Ophthalmology Treatment Study II
ClinicalTrials.gov ID: NCT03011541
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Westport, Connecticut, United States
- Coral Springs, Florida, United States
- Vienna, Austria, Austria
- Dubai, United Arab Emirates, United Arab Emirates
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Westport, Connecticut, United States; Coral Springs, Florida, United States; Vienna, Austria, Austria; Dubai, United Arab Emirates, United Arab Emirates. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.