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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 : Recruiting
First Posted : December 23, 2015
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Stem Cells Arabia

Tracking Information
First Submitted Date  ICMJE December 7, 2015
First Posted Date  ICMJE December 23, 2015
Last Update Posted Date March 17, 2020
Study Start Date  ICMJE April 2013
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
Reduction in degeneration of the optic nerve using the visual field assessment with the Humphrey automated and Goldmann manual perimeters [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2015)
Reduction in degeneration of the Optic nerve with improvement in vision. [ Time Frame: 24 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
improvement in visual function using the documentation of visual acuity using the Snellen chart [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2015)
  • Increase in Visual Function using questionnaires [ Time Frame: 24 months ]
  • Improvement in idiopathic intracranial hypertension using assessment with Humphrey and Goldmann perimeters and documentation of visual acuity and contrast sensitivity [ Time Frame: 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Optic Neuropathies Using Autologous Bone Marrow-Derived Stem Cells
Official Title  ICMJE Treatment of Optic Neuropathies Using Autologous Bone-Marrow Derived Clusters of Differentiation (CD) 34+, 133+, and 271+ Stem Cells: A Pilot Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Optic Neuropathy
Intervention  ICMJE Biological: Stem Cells
Intervention: Transplantation of autologous purified stem cells
Study Arms  ICMJE Experimental: Stem Cells
Intervention: Transplantation of autologous purified stem cells
Intervention: Biological: Stem Cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 19, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Jordan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02638714
Other Study ID Numbers  ICMJE SCA-ON1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stem Cells Arabia
Study Sponsor  ICMJE Stem Cells Arabia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adeeb AlZoubi, PhD
PRS Account Stem Cells Arabia
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP