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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05147701
Recruitment Status : Recruiting
First Posted : December 7, 2021
Last Update Posted : January 5, 2022
Sponsor:
Information provided by (Responsible Party):
The Foundation for Orthopaedics and Regenerative Medicine

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 Eye diseases

Condition or disease Intervention/treatment Phase
Eye Diseases Retinitis Pigmentosa Glaucoma Diabetic Retinopathy Macular Degeneration Traumatic Optic Neuropathy Optic Atrophy Biological: AlloRx Phase 1

Detailed Description:
This patient funded trial aims to study the safety and efficacy of intravenous and sub-tenon delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Eye Diseases. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Eye Diseases
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026


Arm Intervention/treatment
Experimental: Treatment Group (AlloRx)
intravenous and sub-tenon delivery (total dose of 100 million cells)
Biological: AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells




Primary Outcome Measures :
  1. Safety (adverse events) [ Time Frame: Four year follow-up ]
    Clinical monitoring of possible adverse events or complications



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of eye disease
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05147701


Locations
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Antigua and Barbuda
Medical Surgical Associates Center Recruiting
St. John's, Antigua and Barbuda
Contact: Chadwick Prodromos, M.D.    8476996810    care@thepsci.com   
Sponsors and Collaborators
The Foundation for Orthopaedics and Regenerative Medicine
Investigators
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Principal Investigator: Chadwick Prodromos, MD The Foundation for Orthopaedics and Regenerative Medicine
Publications:
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Responsible Party: The Foundation for Orthopaedics and Regenerative Medicine
ClinicalTrials.gov Identifier: NCT05147701    
Other Study ID Numbers: ATG-1-MSC-014
First Posted: December 7, 2021    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by The Foundation for Orthopaedics and Regenerative Medicine:
Eye Diseases
Retinitis Pigmentosa
stem cell treatment
Glaucoma
Diabetic Retinopathy
Macular Degeneration
Traumatic Optic Neuropathy
Optic Atrophy
Additional relevant MeSH terms:
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Optic Nerve Diseases
Optic Atrophy
Optic Nerve Injuries
Glaucoma
Macular Degeneration
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Retinitis
Retinitis Pigmentosa
Atrophy
Ocular Hypertension
Retinal Degeneration
Pathological Conditions, Anatomical
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Genetic Diseases, Inborn
Cranial Nerve Diseases
Nervous System Diseases
Cranial Nerve Injuries
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries