NCT06551649 Human Amniotic Mesenchymal Cell Secretome for Neurodegeneration and Neuroinflammation
| NCT ID | NCT06551649 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-01-17 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-01-17 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Neurodegenerative diseases are debilitating conditions characterized by chronic inflammation, leading to dysfunction of both the non-neuronal cellular components of the central nervous system and peripheral blood immune cells. Thus, it is crucial to develop an innovative therapeutic strategy that not only effectively contrast neurodegeneration but also aims to reduce inflammation. The overall aim of the study is to provide a preclinical in vitro demonstration of the immunomodulatory and pro-regenerative potential of the human amniotic mesenchymal stromal cell (hAMSC) secretome in counteracting neurodegeneration. This potential will be evaluated in three-dimensional in vitro models of neurodegenerative diseases, such as amyotrophic lateral sclerosis (ALS) and chronic demyelinating disease (multiple sclerosis - MS). To this end, the study includes sample collection from patients without pharmacological treatment and without medical devices. Patients diagnosed with ALS, patients diagnosed with MS, and healthy volunteers will be recruited to collect blood samples and skin biopsies. Patient-specific and control organoid platforms, mimicking cellular heterogeneity and tridimensional interactions within the central nervous system including the inflammatory compartment, will be developed to be used as a valuable tool to investigate the in vitro efficacy of the hAMSC secretome.
Eligibility 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.
Contact & Investigator
Ornella Parolini
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06551649 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 60 Years, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06551649 currently recruiting?
Yes, NCT06551649 is actively recruiting participants. Contact the research team at ornella.parolini@policlinicogemelli.it for enrollment information.
Where is the NCT06551649 trial being conducted?
This trial is being conducted at Roma, Italy, Rome, Italy.
Who is sponsoring the NCT06551649 clinical trial?
NCT06551649 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Ornella Parolini at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 60 participants.
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