Clinical trial NCT06551649: Human Amniotic Mesenchymal Cell Secretome for Neurodegeneration and Neuroinflammation
Official title: Contrasting Chronic Inflammation and Neurodegeneration Using the Human Amniotic Mesenchymal Cell Secretome as an Innovative Therapeutic Strategy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Multiple Sclerosis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Primary outcomes:
measure: Neurite length measurement in a three-dimensional cellular model of amyotrophic lateral sclerosis.
timeFrame: 18 months
measure: Percentage of apoptotic cells in a three-dimensional cellular model of amyotrophic lateral sclerosis.
timeFrame: 18 months
measure: Area measurement of damaged myelin in a three-dimensional cellular model of multiple sclerosis.
timeFrame: 18 months
measure: Number of inflamed microglial cells in a three-dimensional cellular model of multiple sclerosis.
timeFrame: 18 months
measure: Neurite length measurement in amyotrophic lateral sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome.
timeFrame: 24 months
measure: Percentage of apoptotic cells in amyotrophic lateral sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome.
timeFrame: 24 months
measure: Area measurement of damaged myelin in multiple sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome.
timeFrame: 24 months
measure: Number of immunoregulatory microglial cells in multiple sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome.
timeFrame: 24 months
Secondary outcomes:
measure: Percentage of altered immune phenotypic markers in amyotrophic lateral sclerosis and multiple sclerosis patients
timeFrame: 18 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Ornella Parolini
role: PRINCIPAL_INVESTIGATOR
References: