Human Amniotic Mesenchymal Cell Secretome for Neurodegeneration and Neuroinflammation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-17

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Amyotrophic Lateral Sclerosis Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Venous blood draw and skin biopsy

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Venous blood draw and skin biopsy

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Venous blood draw and skin biopsy

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes