Human Amniotic Mesenchymal Cell Secretome for Neurodegeneration and Neuroinflammation

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT06551649
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Venous blood draw and skin biopsy — OTHER
    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.

Study Details

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.

Key Dates

First listed
Aug 13, 2024
Start date
Jan 17, 2025
Status verified
Aug 2025
Primary completion
Mar 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Patients diagnosed with amyotrophic lateral sclerosis
    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.
  • Experimental: Patients diagnosed with multiple sclerosis
    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.
  • Active Comparator: Healthy volunteers, patients' unaffected spouses
    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.

Primary Outcome Measure

Neurite length measurement in a three-dimensional cellular model of amyotrophic lateral sclerosis. [ Time Frame: 18 months ]

Central Contacts

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