Running, not recruitingNot a drug-phase studyMS (type not specified)NCT06551649

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Venous blood draw and skin biopsy

What it measured

Main measures

  • Neurite length measurement in a three-dimensional cellular model of amyotrophic lateral sclerosis.

    18 months

  • Percentage of apoptotic cells in a three-dimensional cellular model of amyotrophic lateral sclerosis.

    18 months

  • Area measurement of damaged myelin in a three-dimensional cellular model of multiple sclerosis.

    18 months

  • Number of inflamed microglial cells in a three-dimensional cellular model of multiple sclerosis.

    18 months

    Smouldering inflammationImmune response
  • Neurite length measurement in amyotrophic lateral sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome.

    24 months

  • Percentage of apoptotic cells in amyotrophic lateral sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome.

    24 months

  • Area measurement of damaged myelin in multiple sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome.

    24 months

  • Number of immunoregulatory microglial cells in multiple sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome.

    24 months

    Smouldering inflammation

Other measures (1)

  • Percentage of altered immune phenotypic markers in amyotrophic lateral sclerosis and multiple sclerosis patients

    18 months

    Thinking and memoryImmune response

Who could take part

MS (type not specified) · 20 to 60

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Jan 2025

      2. Main results due

        Mar 2026

      3. Finished

        Feb 2027

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