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

  • STATUS
    Recruiting
  • days left to enroll
    69
  • participants needed
    100
  • sponsor
    Stem Cells Arabia
Updated on 23 January 2021
cell therapy
diabetic retinopathy

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.

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.

Details
Condition EYE DISORDER, Foster-Kennedy Syndrome, Optic Nerve, Eye Disorders/Infections, Dry Eye Disease, Eye Disorders/Infections (Pediatric), Eye Disease, optic neuropathy, optic nerve disorders, optic neuropathies
Treatment Stem cells
Clinical Study IdentifierNCT02638714
SponsorStem Cells Arabia
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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