Human amniotic mesenchymal cell secretome to reduce nerve inflammation and support repair in ALS and MS
Contrasting Chronic Inflammation and Neurodegeneration Using the Human Amniotic Mesenchymal Cell Secretome as an Innovative Therapeutic Strategy
This trial will test whether substances released by human amniotic mesenchymal cells can reduce inflammation and promote nerve repair in people with ALS or recently diagnosed MS using blood and skin samples in laboratory models.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 2 sites (Roma and 1 other locations) |
| Trial ID | NCT06551649 on ClinicalTrials.gov |
What this trial studies
The study collects blood and skin samples from people with ALS, recently diagnosed MS patients not on immunomodulators or corticosteroids, and matched healthy volunteers to generate three-dimensional in vitro models of neurodegeneration. Researchers will apply the secretome (the mix of factors released) from human amniotic mesenchymal stromal cells to these models to observe immunomodulatory and pro-regenerative effects. Outcomes focus on markers of inflammation, neuronal survival, and remyelination in ALS- and MS-relevant lab systems. All work is preclinical and performed in vitro rather than as a therapeutic intervention in patients.
Who should consider this trial
Good fit: Ideal candidates are people with ALS aged 50–60 with similar onset/duration, recently diagnosed MS patients aged 20–50 who are not on immunomodulators or corticosteroids, and healthy spouses matched by age and sex as controls.
Not a fit: Patients in an acute MS flare, those receiving immunomodulatory drugs or corticosteroids, or individuals outside the specified age ranges are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could point to new treatments that reduce inflammation and support nerve repair, potentially slowing disease progression or improving function in ALS and MS.
How similar studies have performed: Preclinical work with mesenchymal stromal cell secretomes has shown promising anti-inflammatory and neuroprotective effects in laboratory and animal models, but clinical application in ALS and MS remains largely unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * For patients with amyotrophic lateral sclerosis (ALS): aged between 50 and 60 years and similar age of onset and duration of the disease. * For patients with multiple sclerosis (MS): with recently confirmed diagnosis of MS, aged between 20 and 50 years and considering the male-to-female ratio in MS of approximately 2:1. * For healthy volunteers: spouses of patients unaffected by any neurological disease and matching their age and gender ratio for both conditions. Exclusion Criteria: * Patients who do not consent to participate in the study. * MS patients who have received treatment with immunomodulators or corticosteroids and are in an acute phase of the disease.
Where this trial is running
Roma and 1 other locations
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, Italy (Not_yet_recruiting)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Ornella Parolini — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Ornella Parolini
- Email: ornella.parolini@policlinicogemelli.it
- Phone: +0630154464
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.