Treatment of Optic Neuropathies Using Autologous Bone Marrow-Derived Stem Cells

Phase 1

• Conditions: Optic Neuropathy
• Interventions: Biological: Stem Cells

• Registration Number: NCT02638714
• Lead Sponsor: Stem Cells Arabia

Brief Summary

A single arm, single center trial to assess the safety and efficacy of restoring function in damaged optic nerves using autologous purified populations of bone-marrow derived stem cells (BM-SCs) through a 24 month follow up period.

Detailed Description

Optic nerve atrophy (ONA) is a condition defined as a damage to the optic nerve that harmfully affects central and peripheral vision. ONA may occur as a result of optic neuritis, compression by tumors or aneurysms, toxic and nutritional neuropathies, trauma, or as a secondary complication to other systemic diseases such as diabetes. Symptoms of ONA vary diversely, but mainly include blurred vision and a reduction in optic sharpness and color visualization. ONA is irreversible process, and current medical strategies focus on finding the underlying cause, and trying to prevent further vision loss and protect the other healthy eye. This is a Single arm, Single Center trial to assess the safety and efficacy of purified adult autologous bone marrow derived CD34+, CD133+, and CD271+ stem cells through a 24 month follow-up period. The combination of these three cell types was based on their diverse potentialities to differentiate into specific functional cell types to regenerate damaged optic nerves and supporting issues and vasculature, and the availability of clinical-grade purification system (CliniMACS) and Microbeads to purify the target cell populations in clinically-approved methods. Anticipated outcomes of this study are defined in an overall improvement of vision, restoration of functions to damaged optic nerves, and improvement in quality of life of patients.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2015-12-07
• Study First Submitted QC: 2015-12-19
• Study First Posted: 2015-12-23
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-15
• Last Update Posted: 2020-03-17
• Primary Completion: 2021-09-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient should suffer from Optic Nerve Atrophy diseases like diabetic retinopathy and retinal pigmentation.
• Age in between 18-55 years old
• Willingness to undergo bone marrow derived autologous cell therapy.
• Ability to comprehend the explained protocol
• Ability and willingness to regularly visit to hospital for protocol and follow up

Exclusion Criteria

• Patients with preexisting or current systemic disease such as lung, liver, gastrointestinal, cardiac, immunodeficiency, syphilis, or clinically relevant polyneuropathies.
• History of life threatening allergic or immune- mediated reaction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem Cells	Stem Cells	Intervention: Transplantation of autologous purified stem cells

Primary Outcome Measures

Name	Time	Method
Reduction in degeneration of the optic nerve using the visual field assessment with the Humphrey automated and Goldmann manual perimeters	24 months

Secondary Outcome Measures

Name	Time	Method
improvement in visual function using the documentation of visual acuity using the Snellen chart	24 months

Trial Locations

Locations (1)

Stem Cells of Arabia; 🇯🇴 Amman, Jordan