Optic NeuropathyPhase 1/2NCT02638714
Treatment of Optic Neuropathies Using Autologous Bone Marrow-Derived Stem Cells
A Phase 1/2 study testing Stem Cells in people with Optic Neuropathy, run by Stem Cells Arabia at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Optic Neuropathy
- What is being tested?
- Stem Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJordan
- Study dates
- Apr 2013to 1 Oct 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
Stem Cells of Arabia
Amman, 11953
Adeeb AlZoubi, PhD, adeebalzoubi@stemcellsarabia.net
Adeeb AlZoubi, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Optic Neuropathy
- Being tested
- Stem Cells
- Keywords
- Optic Neuropathies, Stem Cell Therapy
- Medical subject headings
- Optic Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem CellsBiological
Intervention: Transplantation of autologous purified stem cells
| Study group | Role | What they receive |
|---|---|---|
| Stem Cells | Experimental | Intervention: Transplantation of autologous purified stem cells Receives: Biological: Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in degeneration of the optic nerve using the visual field assessment with the Humphrey automated and Goldmann manual perimeters
Measured: 24 months
Secondary outcomes (1)
improvement in visual function using the documentation of visual acuity using the Snellen chart
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startApr 2013
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stem Cells Arabia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeeb AlZoubi, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638714
- Sponsor's protocol ID
- SCA-ON1
- Status last verified
- Mar 2020
- First submitted
- 7 Dec 2015
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Optic Neuropathies Using Autologous Bone-Marrow Derived Clusters of Differentiation (CD) 34+, 133+, and 271+ Stem Cells: A Pilot Study
- ClinicalTrials.gov ID
- NCT02638714
- Acronym / sponsor ID
- SCA-ON1
- Conditions
- Optic Neuropathy
- Keywords
- Optic Neuropathies, Stem Cell Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stem Cells ArabiaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 23 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem Cells | Experimental | Biological: Stem CellsIntervention: Transplantation of autologous purified stem cells |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stem CellsIntervention: Transplantation of autologous purified stem cells | Biological | Stem Cells |
Primary outcome
Reduction in degeneration of the optic nerve using the visual field assessment with the Humphrey automated and Goldmann manual perimeters
Time frame: 24 months
1 secondary outcome
improvement in visual function using the documentation of visual acuity using the Snellen chart
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeeb AlZoubi, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stem Cells in people with Optic Neuropathy, run by Stem Cells Arabia at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in degeneration of the optic nerve using the visual field assessment with the Humphrey automated and Goldmann manual perimeters (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.