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

Primary Purpose

Optic Neuropathy

Status
Unknown status
Phase
Phase 1
Locations
Jordan
Study Type
Interventional
Intervention
Stem Cells
Sponsored by
Stem Cells Arabia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Optic Neuropathy focused on measuring Optic Neuropathies, Stem Cell Therapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stem Cells of ArabiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem Cells

Arm Description

Intervention: Transplantation of autologous purified stem cells

Outcomes

Primary Outcome Measures

Reduction in degeneration of the optic nerve using the visual field assessment with the Humphrey automated and Goldmann manual perimeters

Secondary Outcome Measures

improvement in visual function using the documentation of visual acuity using the Snellen chart

Full Information

First Posted
December 7, 2015
Last Updated
March 15, 2020
Sponsor
Stem Cells Arabia
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1. Study Identification

Unique Protocol Identification Number
NCT02638714
Brief Title
Treatment of Optic Neuropathies Using Autologous Bone Marrow-Derived Stem Cells
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 Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stem Cells Arabia

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Neuropathy
Keywords
Optic Neuropathies, Stem Cell Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stem Cells
Arm Type
Experimental
Arm Description
Intervention: Transplantation of autologous purified stem cells
Intervention Type
Biological
Intervention Name(s)
Stem Cells
Intervention Description
Intervention: Transplantation of autologous purified stem cells
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
improvement in visual function using the documentation of visual acuity using the Snellen chart
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeeb AlZoubi, PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stem Cells of Arabia
City
Amman
ZIP/Postal Code
11953
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adeeb AlZoubi, PhD
Email
adeebalzoubi@stemcellsarabia.net
First Name & Middle Initial & Last Name & Degree
Adeeb AlZoubi, PhD

12. IPD Sharing Statement

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

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