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

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ClinicalTrials.gov Identifier: NCT02638714
Recruitment Status : Active, not recruiting
First Posted : December 23, 2015
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Optic Neuropathy Biological: Stem Cells Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Optic Neuropathies Using Autologous Bone-Marrow Derived Clusters of Differentiation (CD) 34+, 133+, and 271+ Stem Cells: A Pilot Study
Study Start Date : April 2013
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Stem Cells
Intervention: Transplantation of autologous purified stem cells
Biological: Stem Cells
Intervention: Transplantation of autologous purified stem cells


Outcome Measures

Primary Outcome Measures :
  1. Reduction in degeneration of the optic nerve using the visual field assessment with the Humphrey automated and Goldmann manual perimeters [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. improvement in visual function using the documentation of visual acuity using the Snellen chart [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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): NCT02638714


Locations
Jordan
Stem Cells of Arabia
Amman, Jordan, 11953
Sponsors and Collaborators
Stem Cells Arabia
Investigators
Principal Investigator: Adeeb AlZoubi, PhD
More Information

Responsible Party: Stem Cells Arabia
ClinicalTrials.gov Identifier: NCT02638714     History of Changes
Other Study ID Numbers: SCA-ON1
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: December 2015

Keywords provided by Stem Cells Arabia:
Optic Neuropathies
Stem Cell Therapy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Optic Nerve Diseases
Neuromuscular Diseases
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases