NCT05147701

Brief Summary

This trial will study the safety and efficacy of intravenous and sub-tenon delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of non-arteritic ischemic optic neuropathy

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2022

Longer than P75 for phase_1

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

3.9 years

First QC Date

November 29, 2021

Last Update Submit

April 15, 2025

Conditions

Eye DiseasesRetinitis PigmentosaDiabetic RetinopathyMacular DegenerationTraumatic Optic NeuropathyOptic Atrophy

Keywords

Eye DiseasesRetinitis Pigmentosastem cell treatmentDiabetic RetinopathyMacular DegenerationTraumatic Optic NeuropathyOptic Atrophy

Outcome Measures

Primary Outcomes (1)

  • Safety (adverse events)

    Clinical monitoring of possible adverse events or complications

    Four year follow-up

Study Arms (1)

Treatment Group (AlloRx)

EXPERIMENTAL

intravenous and sub-tenon delivery (total dose of 100 million cells)

Biological: AlloRx

Interventions

AlloRxBIOLOGICAL

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Treatment Group (AlloRx)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of NAION (non-arteritic ischemic optic neuropathy)
  • Understanding and willingness to sign a written informed consent document

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

RECRUITING

Center for Investigation in Tissue Engineering and Cellular Therapy

Buenos Aires, Argentina

RECRUITING

Related Publications (3)

  • Sung Y, Lee SM, Park M, Choi HJ, Kang S, Choi BI, Lew H. Treatment of traumatic optic neuropathy using human placenta-derived mesenchymal stem cells in Asian patients. Regen Med. 2020 Oct;15(10):2163-2179. doi: 10.2217/rme-2020-0044. Epub 2020 Dec 14.

    PMID: 33315474BACKGROUND

  • Zhao T, Liang Q, Meng X, Duan P, Wang F, Li S, Liu Y, Yin ZQ. Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells Maintains and Partially Improves Visual Function in Patients with Advanced Retinitis Pigmentosa. Stem Cells Dev. 2020 Aug;29(16):1029-1037. doi: 10.1089/scd.2020.0037. Epub 2020 Jul 15.

    PMID: 32679004BACKGROUND

  • Ozmert E, Arslan U. Management of retinitis pigmentosa by Wharton's jelly derived mesenchymal stem cells: preliminary clinical results. Stem Cell Res Ther. 2020 Jan 13;11(1):25. doi: 10.1186/s13287-020-1549-6.

    PMID: 31931872BACKGROUND

MeSH Terms

Conditions

Eye DiseasesRetinitis PigmentosaDiabetic RetinopathyMacular DegenerationOptic Nerve InjuriesOptic Atrophy

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesCranial Nerve InjuriesCranial Nerve DiseasesNervous System DiseasesOptic Nerve DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Chadwick Prodromos, MD

    The Foundation for Orthopaedics and Regenerative Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 7, 2021

Study Start

February 1, 2022

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

April 17, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

AN(1)AR(1)