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

NCT ID: NCT02638714

Last Updated: 2020-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2021-10-01

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.

Conditions

Optic Neuropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stem Cells

Intervention: Transplantation of autologous purified stem cells

Group Type: EXPERIMENTAL

Stem Cells

Intervention Type: BIOLOGICAL

Intervention: Transplantation of autologous purified stem cells

Interventions

Stem Cells

Intervention: Transplantation of autologous purified stem cells

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stem Cells Arabia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adeeb AlZoubi, PhD

Role: PRINCIPAL_INVESTIGATOR

Locations

Stem Cells of Arabia

Amman, , Jordan

Site Status: RECRUITING

Countries

Jordan

Facility Contacts

Adeeb AlZoubi, PhD

Role: primary

adeebalzoubi@stemcellsarabia.net

Other Identifiers

SCA-ON1

Identifier Type: -

Identifier Source: org_study_id