Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for NAION

Launched by THE FOUNDATION FOR ORTHOPAEDICS AND REGENERATIVE MEDICINE · Nov 29, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the safety of using special cells called mesenchymal stem cells, which are taken from umbilical cords, to treat various eye diseases such as retinitis pigmentosa, glaucoma, diabetic retinopathy, macular degeneration, traumatic optic neuropathy, and optic atrophy. The researchers want to see if giving these cells through an injection into the vein or near the eye is safe and effective for patients with these conditions.

To join the trial, participants need to have a diagnosed eye disease and be willing to sign a consent form to show they understand the study. However, certain people cannot participate, including those with active infections or cancer, serious organ failures, pregnant women, or those with certain medical conditions that could put their safety at risk. If you or someone you know is interested in this trial, it’s a chance to help researchers learn more about possible new treatments for eye diseases while being closely monitored for any side effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of NAION (non-arteritic ischemic optic neuropathy)
• • Understanding and willingness to sign a written informed consent document
• Exclusion Criteria:
• • Active infection
• • Active cancer
• • Chronic multisystem organ failure
• • Pregnancy
• • Clinically significant Abnormalities on pre-treatment laboratory evaluation
• • Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
• • Continued drug abuse
• • Pre-menopausal women not using contraception
• • Previous organ transplant
• • Hypersensitivity to sulfur