Non Arteritic Ischemic Optic NeuropathyPhase 2NEUROSTEMNCT03173638
Safety Assessment of Intravitreal Mesenchymal Stem Cells for Acute Non Arteritic Anterior Ischemic Optic Neuropathy
A Phase 2 study testing intravitreal injection of MSV in people with Non Arteritic Ischemic Optic Neuropathy, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 1 site in Spain.
Trial summary
In this study the investigators propose to perform a Phase II Clinical Trial which seeks to evaluate the safety of cell therapy as a new treatment for patients who suffer from acute non-arteritic anterior ischemic optic neuropathy (NAION). If it is successful, a later study to assess efficacy will be performed. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Arteritic Ischemic Optic Neuropathy
- What is being tested?
- intravitreal injection of MSV
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSpain
- Study dates
- 23 Mar 2018to Dec 2022
- Phase
- Phase 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute unilateral NAION (within two weeks after the first symptoms) with at least two of the following:
- Sudden and unpainful monocular vision loss
- Visual field defects
- Dyschromatopsia.
- Ocular nerve head edema.
- Afferent relative pupil defect.
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- Patients ≥ 50 years old, able to freely give informed consent.
- Best corrected visual acuity (BCVA) ≤ 0,1 in study eye.
- Pseudophakia in study eye.
- Preserved pupil sphincter muscle motility
- Signed informed consent form before any study procedure.
- Signed data protection consent form before any study procedure.
Who cannot join
- Giant cell arteritis evidence (clinical history, Erythrocyte sedimentation rate (ESR), C-Reactive Protein)
- Evidence of any other etiology that may justify the optic neuropathy (even in the non-study eye)
- History of systemic vasculitis, multiple sclerosis, collagenopathies or previous cancer treatments.
- Hypersensitivity or allergy to any compound used in the study, including investigational medicinal product (IMP).
- Positive pregnancy test at baseline
- Participation in any other research study within 2 months
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- Ophthalmic exclusion criteria
- History of uveitis or active ocular inflammation
- History or evidence of glaucoma or high intraocular pressure ( ≥ 24 mmHg in either eye).
- Mean opacities or retinal pathologies in the study eye.
- Any previous vitreous or glaucoma surgery in the study eye
- Cataract surgery within 3 months in the study eye
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Safety Assessment of Intravitreal Injection of Mesenchymal Stem Cells for Acute Non Arteritic Anterior Ischemic Optic Neuropathy (NAION)
In this study the investigators propose to perform a Phase II Clinical Trial which seeks to evaluate the safety of cell therapy as a new treatment for patients who suffer from acute non-arteritic anterior ischemic optic neuropathy (NAION). If it is successful, a later study to assess efficacy will be performed.
This disease has an age-adjusted incidence rate of 10/100.000, and in many cases it results in blindness. Currently, there is no available treatment and second eye involvement occurs in approximately 15-25% of the cases.
Read more
All this background originates a particularly dramatic outcome for the patient. Therefore, it seems justified to evaluate new therapies that maintain or improve the visual function in these patients.
The Project includes a clinical trial whose purpose is the assessment of the safety of intravitreal administration of allogenic mesenchymal stem cells (MSC) in patients with NAION, a product in clinical research phase (PEI No. 15-007) already approved for other human clinical applications (PEI No. 15-007).
It can be considered that the therapy with intravitreal injection of MSC is a treatment option in patients with acute NAION, since through the paracrine properties of these cells (secretion of neurotrophic, immunomodulatory and anti-apoptotic factors) it may prevent or reduce the progression of axonal degeneration caused by this disease.
- Conditions
- Non Arteritic Ischemic Optic Neuropathy
- Being tested
- intravitreal injection of MSV
- Keywords
- acute non arteritic anterior ischemic optic neuropathy, mesenchymal stem cells, intravitreal injection, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal injection of MSVProcedure or surgery
A unique intravitreal injection of MSV in acute fase of NAION
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem from valladolid (MSV) | Experimental | Allogenic mesenchymal stem cells from bone marrow Receives: Procedure: intravitreal injection of MSV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of inflammatory reaction - Slit lamp exploration - SUN (Standardization of Uveitis Nomenclature) scale
Following the SUN scale, the parameters that will be taken into account in the slit lamp exploration will be: cells and flare in anterior chamber, and vitreous flare
Measured: Changes compared to baseline in visits V1 (1day), V2 (1week), V3 (1 month), V4 (3 months), V5 (6 months) and V6 (12months) and in any unscheduled visit any patient might need
Secondary outcomes (1)
Adverse events procedure-related (intravitreal injection)
Conjunctival haemorrhages, anterior chamber inflammation, changes in intraocular pressure, infectious endophthalmitis, vitreous inflammation, retinal detachment, choroidal detachment, corneal opacities, lens opacities, neovascularization, macular edema or any other adverse event that may appear
Measured: Throughout the study after treatment in visits V1 (1day), V2 (1week), V3 (1 month), V4 (3 months), V5 (6 months) and V6 (12months) and in any unscheduled visit any patient might need
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start23 Mar 2018
- Primary completionApr 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Arteritic Ischemic 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valladolid
- Responsible party
- Sponsor
- Investigators
- José C Pastor Jimeno, MD, PhD, Principal investigator, IOBA-UVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173638
- Sponsor's protocol ID
- IOBA01-2016
- Other IDs
- 2016-003029-40, 2016
- Acronym
- NEUROSTEM
- Status last verified
- Apr 2021
- First submitted
- 24 May 2017
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pastor JC, Pastor-Idoate S, Lopez-Paniagua M, Para M, Blazquez F, Murgui E, Garcia V, Coco-Martin RM. Intravitreal allogeneic mesenchymal stem cells: a non-randomized phase II clinical trial for acute non-arteritic optic neuropathy. Stem Cell Res Ther. 2023 Sep 21;14(1):261. doi: 10.1186/s13287-023-03500-7.
PubMed 37735668
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Safety Assessment of Intravitreal Injection of Mesenchymal Stem Cells for Acute Non Arteritic Anterior Ischemic Optic Neuropathy (NAION)
- ClinicalTrials.gov ID
- NCT03173638
- Acronym / sponsor ID
- NEUROSTEM / IOBA01-2016
- Conditions
- Non Arteritic Ischemic Optic Neuropathy
- Keywords
- acute non arteritic anterior ischemic optic neuropathy, mesenchymal stem cells, intravitreal injection, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBAUniversity, hospital or other
- Collaborators
- University of Valladolid
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Jun 2017 (actual)
- 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.
In this study the investigators propose to perform a Phase II Clinical Trial which seeks to evaluate the safety of cell therapy as a new treatment for patients who suffer from acute non-arteritic anterior ischemic optic neuropathy (NAION). If it is successful, a later study to assess efficacy will be performed.
This disease has an age-adjusted incidence rate of 10/100.000, and in many cases it results in blindness. Currently, there is no available treatment and second eye involvement occurs in approximately 15-25% of the cases.
All this background originates a particularly dramatic outcome for the patient. Therefore, it seems justified to evaluate new therapies that maintain or improve the visual function in these patients.
The Project includes a clinical trial whose purpose is the assessment of the safety of intravitreal administration of allogenic mesenchymal stem cells (MSC) in patients with NAION, a product in clinical research phase (PEI No. 15-007) already approved for other human clinical applications (PEI No. 15-007).
It can be considered that the therapy with intravitreal injection of MSC is a treatment option in patients with acute NAION, since through the paracrine properties of these cells (secretion of neurotrophic, immunomodulatory and anti-apoptotic factors) it may prevent or reduce the progression of axonal degeneration caused by this disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem from valladolid (MSV) | Experimental | Procedure: intravitreal injection of MSVAllogenic mesenchymal stem cells from bone marrow |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with acute unilateral NAION (within two weeks after the first symptoms) with at least two of the following:
- Patients ≥ 50 years old, able to freely give informed consent.
- Best corrected visual acuity (BCVA) ≤ 0,1 in study eye.
- Pseudophakia in study eye.
- Preserved pupil sphincter muscle motility
Key exclusion criteria (12 listed)
- Giant cell arteritis evidence (clinical history, Erythrocyte sedimentation rate (ESR), C-Reactive Protein)
- Evidence of any other etiology that may justify the optic neuropathy (even in the non-study eye)
- History of systemic vasculitis, multiple sclerosis, collagenopathies or previous cancer treatments.
- Hypersensitivity or allergy to any compound used in the study, including investigational medicinal product (IMP).
- Positive pregnancy test at baseline
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 |
|---|---|---|
| intravitreal injection of MSVA unique intravitreal injection of MSV in acute fase of NAION | Procedure or surgery | Mesenchymal stem from valladolid (MSV) |
Primary outcome
Absence of inflammatory reaction - Slit lamp exploration - SUN (Standardization of Uveitis Nomenclature) scale
Time frame: Changes compared to baseline in visits V1 (1day), V2 (1week), V3 (1 month), V4 (3 months), V5 (6 months) and V6 (12months) and in any unscheduled visit any patient might need
Following the SUN scale, the parameters that will be taken into account in the slit lamp exploration will be: cells and flare in anterior chamber, and vitreous flare
1 secondary outcome
Adverse events procedure-related (intravitreal injection)
Time frame: Throughout the study after treatment in visits V1 (1day), V2 (1week), V3 (1 month), V4 (3 months), V5 (6 months) and V6 (12months) and in any unscheduled visit any patient might need
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Derived from this study: PubMed 37735668Pastor JC, Pastor-Idoate S, Lopez-Paniagua M, Para M, Blazquez F, Murgui E, Garcia V, Coco-Martin RM. Intravitreal allogeneic mesenchymal stem cells: a non-randomized phase II clinical trial for acute non-arteritic optic neuropathy. Stem Cell Res Ther. 2023 Sep 21;14(1):261. doi: 10.1186/s13287-023-03500-7.
- European Union Clinical Trials RegisterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
José C Pastor Jimeno, MD, PhD principal investigator
IOBA-UVA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intravitreal injection of MSV in people with Non Arteritic Ischemic Optic Neuropathy, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 1 site in Spain.
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 12 inclusion and 12 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 6 Apr 2021. 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 Spain. 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 phase mean?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of inflammatory reaction - Slit lamp exploration - SUN (Standardization of Uveitis Nomenclature) scale (time frame: Changes compared to baseline in visits V1 (1day), V2 (1week), V3 (1 month), V4 (3 months), V5 (6 months) and V6 (12months) and in any unscheduled visit any patient might need). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03173638, which also lists 1 linked publication.
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 6 Apr 2021.