- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02638714
Treatment of Optic Neuropathies Using Autologous Bone Marrow-Derived Stem Cells
March 15, 2020 updated by: Stem Cells Arabia
Treatment of Optic Neuropathies Using Autologous Bone-Marrow Derived Clusters of Differentiation (CD) 34+, 133+, and 271+ Stem Cells: A Pilot Study
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.
Study Overview
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
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amman, Jordan, 11953
- Recruiting
- Stem Cells of Arabia
-
Contact:
- Adeeb AlZoubi, PhD
- Email: adeebalzoubi@stemcellsarabia.net
-
Principal Investigator:
- Adeeb AlZoubi, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stem Cells
Intervention: Transplantation of autologous purified stem cells
|
Intervention: Transplantation of autologous purified stem cells
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in degeneration of the optic nerve using the visual field assessment with the Humphrey automated and Goldmann manual perimeters
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
improvement in visual function using the documentation of visual acuity using the Snellen chart
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adeeb AlZoubi, PhD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Anticipated)
September 1, 2021
Study Completion (Anticipated)
October 1, 2021
Study Registration Dates
First Submitted
December 7, 2015
First Submitted That Met QC Criteria
December 19, 2015
First Posted (Estimate)
December 23, 2015
Study Record Updates
Last Update Posted (Actual)
March 17, 2020
Last Update Submitted That Met QC Criteria
March 15, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCA-ON1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Optic Neuropathy
-
Shahid Beheshti University of Medical SciencesUnknownAcute Nonarteritic Anterior Ischemic Optic NeuropathyIran, Islamic Republic of
-
Rigshospitalet, DenmarkUniversity of Colorado, Denver; King's College Hospital NHS Trust; Odense University... and other collaboratorsRecruitingNon-arteritic Ischemic Optic Neuropathy | Optic Disk DrusenDenmark, United Kingdom, United States, Australia, Canada, France, Iran, Islamic Republic of, Israel, New Zealand
-
Shahid Beheshti University of Medical SciencesUnknownNon-Arteritic Anterior Ischemic Optic Neuropathy (NAION)Iran, Islamic Republic of
-
Instituto Universitario de Oftalmobiología Aplicada...University of ValladolidActive, not recruitingNon Arteritic Ischemic Optic NeuropathySpain
-
Fraser HealthWithdrawnIschemic Optic Neuropathy | Optic Neuropathy, Ischemic | Anterior Ischemic Optic Neuropathy | Optic Neuropathy, Anterior IschemicCanada
-
Emory UniversityCompletedNon-Arteritic Anterior Ischemic Optic NeuropathyUnited States
-
Eli Lilly and CompanyCompletedNonarteritic Anterior Ischemic Optic NeuropathyUnited States
-
Shahid Beheshti University of Medical SciencesUnknownNAION( Non-arteritic Anterior Ischemic Optic Neuropathy)Iran, Islamic Republic of
-
Jeffrey L GoldbergCompletedIschemic Optic Neuropathy/Optic Nerve StrokeUnited States
-
Medical University of BialystokUniversity of BialystokRecruitingOptic Neuritis | Ischemic Optic Neuropathy | Traumatic Optic Neuropathy | Toxic Optic Neuropathy | Compressive Optic Neuropathy | Hereditary Optic NeuropathiesPoland
Clinical Trials on Stem Cells
-
StemCells, Inc.WithdrawnNeuronal Ceroid LipofuscinosisUnited States
-
University College, LondonUnknownTendinopathy | Achilles Tendinitis | Achilles Degeneration | Achilles Tendinitis, Right Leg | Achilles Tendon Thickening | Achilles Tendinitis, Left LegUnited Kingdom
-
Hadassah Medical OrganizationCompletedAmyotrophic Lateral Sclerosis
-
Honya Medical IncChang Gung Memorial HospitalNot yet recruitingCoronary Artery DiseaseTaiwan
-
El-Rayadh Fertility CentreUnknownPremature Ovarian FailureEgypt
-
Hospital ZnojmoUnknown
-
Guangzhou General Hospital of Guangzhou Military...UnknownSpinal Cord InjuryChina
-
Guangzhou General Hospital of Guangzhou Military...Guangzhou Municipal Twelfth People's Hospital; Guangdong Prevention and Treatment...Unknown
-
National Research Center for Hematology, RussiaUnknownRelapse | Graft-versus-host DiseaseRussian Federation
-
Guangzhou General Hospital of Guangzhou Military...UnknownParkinson's DiseaseChina