Human Amniotic Mesenchymal Cell Secretome for Neurodegeneration and Neuroinflammation
Recruiting
N/AInterventional Study
Amyotrophic Lateral SclerosisMultiple Sclerosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
20 – 60
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
60 (estimated)
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Other
Who this trial is looking for
This trial is looking for patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS) and healthy volunteers. Participants will provide blood samples and skin biopsies to help investigate a potential treatment using human cells.
Are You a Good Fit for This Trial?
You may be able to join if
I am aged between 50 and 60 and have ALS.
I have recently been diagnosed with MS and am aged between 20 and 50.
I am the spouse of a patient and do not have any neurological disease.
You may not be able to join if
I do not consent to participate in the study.
I have received treatment with immunomodulators or corticosteroids for my MS.
I am in an acute phase of my MS.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.