Multiple System AtrophyPhase 1NCT05698017
Study to Evaluate Investigational Allogeneic Cell Therapy Product hOMSC300 for Treatment of Early to Moderate Stage Multiple System Atrophy (MSA)
A Phase 1 study testing hOMSC300 in people with Multiple System Atrophy and MSA - Multiple System Atrophy, run by Cytora Ltd. at 1 site in Israel.
Trial summary
Purpose of this phase 1 study is to assess the safety of intrathecal administration of allogeneic human oral mucosa stem cells (hOMSCs) in patients suffering from early to moderate stage Multiple System Atrophy (MSA) Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Multiple System Atrophy, MSA - Multiple System Atrophy
- What is being tested?
- hOMSC300
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 7 Nov 2022to 19 Feb 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient was diagnosed with probable MSA-C (cerebellar) or MSA-P (parkinsonian) variant within 60 months of symptom onset (excluding impotence)
- Subject can ambulate without the assistance of another person, defined as the ability to take at least 10 steps. Use of assistive devices is allowed
- Patient cognitive state permits him to sign informed consent, according to the PI's clinical judgement, and MoCA >= 24
Who cannot join
- Pregnant women and women before menopause
- Participants with a clinically significant or unstable medical or surgical condition that, in the opinion of the investigator, might preclude safe completion of the treatment or affect the treatment outcome.
- Patients with thrombocytopenia, other bleeding diathesis or taking anticoagulant therapy (not including Aspirin up to 100mg per day)
- Patients with known hypersensitivities to Plasmalyte, Gadolinium, Penicillin, and with general hypersensitivity to antibiotics
- Patients who fulfill the criteria of Parkinson's Disease
- History of electroconvulsive therapy
- History of brain surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Open-Label Study for Treatment of Early to Moderate Stage Multiple System Atrophy Patients With the Investigational Allogeneic Cell Therapy Product, hOMSC300
Purpose of this phase 1 study is to assess the safety of intrathecal administration of allogeneic human oral mucosa stem cells (hOMSCs) in patients suffering from early to moderate stage Multiple System Atrophy (MSA)
- Being tested
- hOMSC300
- Keywords
- multiple system atrophy, MSA, stem cells, intrathecal
- Medical subject headings
- Multiple System Atrophy, Shy-Drager Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hOMSC300Biological
Human Oral Mucosa Stem Cells
| Study group | Role | What they receive |
|---|---|---|
| Low dose hOMSC300 | Experimental | Single IT administration of low dose hOMSC300 Receives: Biological: hOMSC300 |
| High dose hOMSC300 | Experimental | Single IT administration of high dose hOMSC300 Receives: Biological: hOMSC300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment related serious adverse events (SAEs)
Measured: 18 months
Number of participants with treatment related adverse events (AEs)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start7 Nov 2022
- Primary completion19 Feb 2026 (estimated)
- Study completion19 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System AtrophyStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Patients will be allocated to one of the following arms: 1. The first 2 subjects recruited will be treated with the Low dose single Intrathecal (IT) administration of hOMSC300 2. The following 2 subjects recruited will be treated with the High dose single intrathecal (IT) administration of hOMSC300; In the absence of any treatment related SAEs, the remaining patients (6) will be treated with the high dose, without further staggering.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytora Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698017
- Sponsor's protocol ID
- Cyt MSA hOMSC300
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Open-Label Study for Treatment of Early to Moderate Stage Multiple System Atrophy Patients With the Investigational Allogeneic Cell Therapy Product, hOMSC300
- ClinicalTrials.gov ID
- NCT05698017
- Acronym / sponsor ID
- Cyt MSA hOMSC300
- Keywords
- multiple system atrophy, MSA, stem cells, intrathecal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cytora Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 19 Feb 2026 (estimated)
- Study completion
- 19 Feb 2026 (estimated)
- First posted
- 26 Jan 2023 (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.
Purpose of this phase 1 study is to assess the safety of intrathecal administration of allogeneic human oral mucosa stem cells (hOMSCs) in patients suffering from early to moderate stage Multiple System Atrophy (MSA)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be allocated to one of the following arms: 1. The first 2 subjects recruited will be treated with the Low dose single Intrathecal (IT) administration of hOMSC300 2. The following 2 subjects recruited will be treated with the High dose single intrathecal (IT) administration of hOMSC300; In the absence of any treatment related SAEs, the remaining patients (6) will be treated with the high dose, without further staggering.
| Arm | Type | Receives |
|---|---|---|
| Low dose hOMSC300 | Experimental | Biological: hOMSC300Single IT administration of low dose hOMSC300 |
| High dose hOMSC300 | Experimental | Biological: hOMSC300Single IT administration of high dose hOMSC300 |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient was diagnosed with probable MSA-C (cerebellar) or MSA-P (parkinsonian) variant within 60 months of symptom onset (excluding impotence)
- Subject can ambulate without the assistance of another person, defined as the ability to take at least 10 steps. Use of assistive devices is allowed
- Patient cognitive state permits him to sign informed consent, according to the PI's clinical judgement, and MoCA >= 24
Key exclusion criteria (7 listed)
- Pregnant women and women before menopause
- Participants with a clinically significant or unstable medical or surgical condition that, in the opinion of the investigator, might preclude safe completion of the treatment or affect the treatment outcome.
- Patients with thrombocytopenia, other bleeding diathesis or taking anticoagulant therapy (not including Aspirin up to 100mg per day)
- Patients with known hypersensitivities to Plasmalyte, Gadolinium, Penicillin, and with general hypersensitivity to antibiotics
- Patients who fulfill the criteria of Parkinson's Disease
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 |
|---|---|---|
| hOMSC300Human Oral Mucosa Stem Cells | Biological | High dose hOMSC300, Low dose hOMSC300 |
Primary outcome
Number of participants with treatment related serious adverse events (SAEs)
Time frame: 18 months
Number of participants with treatment related adverse events (AEs)
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hOMSC300 in people with Multiple System Atrophy and MSA - Multiple System Atrophy, run by Cytora Ltd. at 1 site in Israel.
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 3 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2025. 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 Israel. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants with treatment related serious adverse events (SAEs) (time frame: 18 months). The study lists 2 primary outcomes in all. 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 29 Jan 2025.