Human Amniotic Mesenchymal Cell Secretome for Neurodegeneration and Neuroinflammation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Venous blood draw and skin biopsy.
- Who it may be relevant to
- Registry conditions: Amyotrophic Lateral Sclerosis, Multiple Sclerosis. Basic parameters: 20 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Contrasting Chronic Inflammation and Neurodegeneration Using the Human Amniotic Mesenchymal Cell Secretome as an Innovative Therapeutic Strategy
Overview
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.
Interventions
- Other Venous blood draw and skin biopsy
The skin tissue will be used to isolate fibroblasts, which will then be reprogrammed into induced pluripotent stem cells (iPSCs). These iPSCs will be differentiated to develop patient-specific and control organoids. The blood samples will be used to isolate peripheral blood mononuclear cells (PBMC) to study the contribution of inflammation in the in vitro models developed.
Primary outcome measures
- Neurite length measurement in a three-dimensional cellular model of amyotrophic lateral sclerosis. [Time frame: 18 months]
- Percentage of apoptotic cells in a three-dimensional cellular model of amyotrophic lateral sclerosis. [Time frame: 18 months]
- Area measurement of damaged myelin in a three-dimensional cellular model of multiple sclerosis. [Time frame: 18 months]
- Number of inflamed microglial cells in a three-dimensional cellular model of multiple sclerosis. [Time frame: 18 months]
- Neurite length measurement in amyotrophic lateral sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome. [Time frame: 24 months]
- Percentage of apoptotic cells in amyotrophic lateral sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome. [Time frame: 24 months]
- Area measurement of damaged myelin in multiple sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome. [Time frame: 24 months]
- Number of immunoregulatory microglial cells in multiple sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome. [Time frame: 24 months]
Secondary outcome measures (1)
- Percentage of altered immune phenotypic markers in amyotrophic lateral sclerosis and multiple sclerosis patients [Time frame: 18 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Italy · 2 centers
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome
Identifiers
NCT: NCT06551649 · 6823