Clinical trial NCT05147701: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for NAION
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Non-arteritic Ischemic Optic Neuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Eye Diseases
Retinitis Pigmentosa
Diabetic Retinopathy
Macular Degeneration
Traumatic Optic Neuropathy
Optic Atrophy
Keywords: Eye Diseases
Retinitis Pigmentosa
stem cell treatment
Diabetic Retinopathy
Macular Degeneration
Traumatic Optic Neuropathy
Optic Atrophy
Lead sponsor: The Foundation for Orthopaedics and Regenerative Medicine
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 non-arteritic ischemic optic neuropathy. 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.

For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

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

Primary outcomes:
measure: Safety (adverse events)
timeFrame: Four year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: St. John's
country: Antigua and Barbuda
facility: Medical Surgical Associates Center
city: Buenos Aires
country: Argentina
facility: Center for Investigation in Tissue Engineering and Cellular Therapy
Study officials:
affiliation: The Foundation for Orthopaedics and Regenerative Medicine
name: Chadwick Prodromos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.