Motor DisordersPhase 1NCT07105371
Patients With ALS and Other Motor Disorders Will be Treated With Umbilical or Placental Mesenchymal Cell Exosome Solution
A Phase 1 study testing Exosome Secretome in people with Motor Disorders, run by The Foundation for Orthopaedics and Regenerative Medicine at 2 sites in 2 countries.
Trial summary
Patients with ALS and other Motor Discorders will be treated with mesenchymal cell exosome solution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Motor Disorders
- What is being tested?
- Exosome Secretome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Jul 2024to 14 May 2026
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will need a diagnosis established by a neurologist. Patients must be able to provide informed consent, or have a guardian who does. They must be able to travel to the site of treatment.
Who cannot join
- Patients were excluded from the trial if they were pregnant or had active cancer at the screening consultation.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Prodromos Stem Cell Institute
Naples, Florida, 34102
About this study
Official title: Patients With ALS and Other Motor Discorders Will be Treated With Mesenchymal Cell Exosome Solution
Patients with ALS and other Motor Discorders will be treated with mesenchymal cell exosome solution.
Read the detailed description
Single Arm non-controlled study. Patients are prospectively evaluated then treated. Outcomes are tracked after treatment.
- Conditions
- Motor Disorders
- Being tested
- Exosome Secretome
- Keywords
- exosomes, secretome, ALS, Kennedy disease, Congenital Myasthenic Syndrome, Lewy body dementia
- Medical subject headings
- Motor Disorders, Bulbo-Spinal Atrophy, X-Linked, Myasthenic Syndromes, Congenital, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exosome SecretomeBiological
This is an intranasal treatment of exosomes derived from Umbilical or Placental Derived Mesenchymal Stem Cells.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group (Exosome Secretome) | Experimental | Not described Receives: Biological: Exosome Secretome |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALSFRS-R Results
Measured: from enrollment until 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start14 Jul 2024
- Primary completion1 May 2026
- Study completion14 May 2026
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 Motor DisordersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Foundation for Orthopaedics and Regenerative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105371
- Sponsor's protocol ID
- FOREM2024EX01
- Status last verified
- Oct 2026
- First submitted
- 22 Jul 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Prodromos CC, Del Villar R, Jin MY, Abd-Elsayed A, Candido K. Exosome-rich mesenchymal stem cell secretome improves strength in patients with amyotrophic lateral sclerosis, Kennedy disease, congenital myasthenic syndrome and Lewy body dementia. Am J Stem Cells. 2025 Oct 15;14(4):217-229. doi: 10.62347/FTXA8845. eCollection 2025.
PubMed 41278139
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients With ALS and Other Motor Discorders Will be Treated With Mesenchymal Cell Exosome Solution
- ClinicalTrials.gov ID
- NCT07105371
- Acronym / sponsor ID
- FOREM2024EX01
- Conditions
- Motor Disorders
- Keywords
- exosomes, secretome, ALS, Kennedy disease, Congenital Myasthenic Syndrome, Lewy body dementia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- The Foundation for Orthopaedics and Regenerative MedicineUniversity, hospital or other
- Study start
- 14 Jul 2024 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 14 May 2026 (actual)
- First posted
- 5 Aug 2025 (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.
Patients with ALS and other Motor Discorders will be treated with mesenchymal cell exosome solution.
Detailed description
Single Arm non-controlled study. Patients are prospectively evaluated then treated. Outcomes are tracked after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group (Exosome Secretome) | Experimental | Biological: Exosome Secretome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients will need a diagnosis established by a neurologist. Patients must be able to provide informed consent, or have a guardian who does. They must be able to travel to the site of treatment.
Key exclusion criteria (1 listed)
- Patients were excluded from the trial if they were pregnant or had active cancer at the screening consultation.
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 |
|---|---|---|
| Exosome SecretomeThis is an intranasal treatment of exosomes derived from Umbilical or Placental Derived Mesenchymal Stem Cells. | Biological | Treatment Group (Exosome Secretome) |
Primary outcome
ALSFRS-R Results
Time frame: from enrollment until 6 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Derived from this study: PubMed 41278139Prodromos CC, Del Villar R, Jin MY, Abd-Elsayed A, Candido K. Exosome-rich mesenchymal stem cell secretome improves strength in patients with amyotrophic lateral sclerosis, Kennedy disease, congenital myasthenic syndrome and Lewy body dementia. Am J Stem Cells. 2025 Oct 15;14(4):217-229. doi: 10.62347/FTXA8845. eCollection 2025.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exosome Secretome in people with Motor Disorders, run by The Foundation for Orthopaedics and Regenerative Medicine at 2 sites in 2 countries.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ALSFRS-R Results (time frame: from enrollment until 6 months after treatment). 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 NCT07105371, 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 16 Oct 2026.