Human Amniotic Mesenchymal Cell Secretome for Neurodegeneration and Neuroinflammation (CONTRASTOME)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Multiple Sclerosis; Amyotrophic Lateral Sclerosis

Treatments: Other: Venous blood draw and skin biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06551649

6823

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Patients diagnosed with amyotrophic lateral sclerosis

Experimental group

Description:

Amyotrophic lateral sclerosis patients will be recruited to obtain venous blood draw and skin biopsy, to optimize a three-dimensional cellular model of multiple sclerosis in which determine the neuroprotective and anti-inflammatory/immunomodulatory effects of the human amniotic mesenchymal stromal cell secretome.

Treatment:

Other: Venous blood draw and skin biopsy

Patients diagnosed with multiple sclerosis

Experimental group

Description:

Multiple sclerosis patients will be recruited to obtain venous blood draw and skin biopsy, to optimize a three-dimensional cellular model of multiple sclerosis in which determine the neuroprotective and anti-inflammatory/immunomodulatory effects of the human amniotic mesenchymal stromal cell secretome.

Treatment:

Other: Venous blood draw and skin biopsy

Healthy volunteers, patients' unaffected spouses

Active Comparator group

Description:

Spouses of patients will be enrolled as healthy controls, matching their age and male-to-female ratio for both conditions, to obtain venous blood draw and skin biopsy, in order to develop a control model against which to evaluate the preclinical efficacy of the human amniotic mesenchymal stromal cell secretome.

Treatment:

Other: Venous blood draw and skin biopsy