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Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Exosomes for NAION

RecruitingPhase 1

Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Exosomes for the Treatment of Non-arteritic Ischemic Optic Neuropathy

Who can join

All ages · All sexes

Full 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

About the study

This trial will study the safety and efficacy of intranasal delivery of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes for the treatment of non-arteritic ischemic optic neuropathy

What is being tested

Sponsor: The Foundation for Orthopaedics and Regenerative Medicine · Participants: 20 · Started: Feb 1, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05147701

Locations in the U.S.

FloridaProdromos Stem Cell Institute, Naples

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.