Recruiting
Phase 1

Exosomes

Sponsor:

The Foundation for Orthopaedics and Regenerative Medicine

Code:

NCT05147701

Conditions

Eye Diseases

Retinitis Pigmentosa

Diabetic Retinopathy

Macular Degeneration

Traumatic Optic Neuropathy

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes

Study Details

Brief summary:

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

Conditions

Eye Diseases

Retinitis Pigmentosa

Diabetic Retinopathy

Macular Degeneration

Traumatic Optic Neuropathy

Study ID

NCT05147701

Start date

Feb 1, 2022

Status verified date

Oct, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

Intranasal delivery

Interventions

cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes

cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes

Primary outcome measure

  • Safety (adverse events) [ Time Frame: Four year follow-up ]

Central Contacts and Locations

Central contacts

Chadwick Prodromos, MD

847-699-6810care@thepsci.com

Locations

Prodromos Stem Cell Institute

Recruiting

Naples, Florida, United States, 34102

Contacts

Chadwick Prodromos, MD

847-699-6810care@thepsci.com

More Information

Sponsor

The Foundation for Orthopaedics and Regenerative Medicine

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

  • Eye Diseases
  • Retinitis Pigmentosa
  • stem cell treatment
  • Diabetic Retinopathy
  • Macular Degeneration
  • Traumatic Optic Neuropathy
  • Optic Atrophy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by The Foundation for Orthopaedics and Regenerative Medicine on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.