Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Eye Diseases
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| ClinicalTrials.gov Identifier: NCT05147701 |
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Recruitment Status :
Recruiting
First Posted : December 7, 2021
Last Update Posted : January 5, 2022
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Sponsor:
The Foundation for Orthopaedics and Regenerative Medicine
Information provided by (Responsible Party):
The Foundation for Orthopaedics and Regenerative Medicine
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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 |
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.
| 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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment Group (AlloRx)
intravenous and sub-tenon delivery (total dose of 100 million cells)
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Biological: AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells |
Primary Outcome Measures :
- Safety (adverse events) [ Time Frame: Four year follow-up ]Clinical monitoring of possible adverse events or complications
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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
| 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
| Principal Investigator: | Chadwick Prodromos, MD | The Foundation for Orthopaedics and Regenerative Medicine |
Publications:
| 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 |
| 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:
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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 |