Amyotrophic Lateral SclerosisCONTRASTOMENCT06551649
Human Amniotic Mesenchymal Cell Secretome for Neurodegeneration and Neuroinflammation
A study testing Venous blood draw and skin biopsy in people with Amyotrophic Lateral Sclerosis and Multiple Sclerosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Multiple Sclerosis
- What is being tested?
- Venous blood draw and skin biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesItaly
- Study dates
- 17 Jan 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Italy2 sites
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
About this study
Official title: Contrasting Chronic Inflammation and Neurodegeneration Using the Human Amniotic Mesenchymal Cell Secretome as an Innovative Therapeutic Strategy
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.
- Conditions
- Amyotrophic Lateral Sclerosis, Multiple Sclerosis
- Being tested
- Venous blood draw and skin biopsy
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous blood draw and skin biopsyOther
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 group | Role | What they receive |
|---|---|---|
| Patients diagnosed with amyotrophic lateral sclerosis | Experimental | 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. Receives: Other: Venous blood draw and skin biopsy |
| Patients diagnosed with multiple sclerosis | Experimental | 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. Receives: Other: Venous blood draw and skin biopsy |
| Healthy volunteers, patients' unaffected spouses | Active comparator | 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. Receives: Other: Venous blood draw and skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurite length measurement in a three-dimensional cellular model of amyotrophic lateral sclerosis.
Organoids from induced pluripotent stem cells (iPSCs) isolated from skin biopsies of 6 amyotrophic lateral sclerosis (ALS) patients and 6 healthy controls will be generated. Neurite degeneration will be measured in fluorescence microscopy as total βIII-TUBULIN-positive fiber length divided by the number of βIII-TUBULIN-positive cells in micrometers. Measurements will be taken from at least 5 ALS and 5 control organoids to analyze correlations and differences between groups. The significance level for statistical tests and models is set at 0.05.
Measured: 18 months
Percentage of apoptotic cells in a three-dimensional cellular model of amyotrophic lateral sclerosis.
Organoids from induced pluripotent stem cells (iPSCs) isolated from skin biopsies of 6 amyotrophic lateral sclerosis (ALS) patients and 6 healthy controls will be generated. Apoptosis will be assessed by the percentage of propidium iodide-positive cells, representing the proportion of dead cells relative to the total number of cells. Measurements will be taken from at least 5 ALS and 5 control organoids to analyze correlations and differences between groups. The significance level for statistical tests and models is set at 0.05.
Measured: 18 months
Area measurement of damaged myelin in a three-dimensional cellular model of multiple sclerosis.
Organoids from induced pluripotent stem cells (iPSCs) isolated from skin biopsies of 6 multiple sclerosis (MS) patients and 6 healthy controls will be generated. Myelin sheath damage will be assessed via immunofluorescence as the reduction in myelin marker-stained area versus total section area. Measurements will be taken from at least 5 MS and 5 control organoids to analyze correlations and differences between groups. The significance level for statistical tests and models is set at 0.05.
Measured: 18 months
Number of inflamed microglial cells in a three-dimensional cellular model of multiple sclerosis.
Organoids from induced pluripotent stem cells (iPSCs) isolated from skin biopsies of 6 multiple sclerosis (MS) patients and 6 healthy controls will be generated. Microglial activation will be assessed by morphological variations, classifying cells as homeostatic, ramified, hyper-ramified, or amoeboid. Inflammatory microglia increase will be defined as the proportion of activated morphology cells relative to total cell count. Inflammatory markers HLA-DR and iNOS will be evaluated in terms of CD68 and IBA1 positive cells and fluorescence intensity. Measurements will be taken from at least 5 MS and 5 control organoids to analyze correlations and differences between groups. The significance level for statistical tests and models is set at 0.05.
Measured: 18 months
Neurite length measurement in amyotrophic lateral sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome.
Neurite length in amyotrophic lateral sclerosis (ALS)-derived organoids treated with human amniotic mesenchymal stromal cell (hAMSC) secretome will be quantified using fluorescence microscopy as the total βIII-TUBULIN-positive fiber length divided by the number of βIII-TUBULIN-positive cells. The ability of the hAMSC secretome to restore ALS organoids (at least 5) to values close to healthy-donors organoids (at least 5) will be evaluated. The significance level is set at 0.05.
Measured: 24 months
Percentage of apoptotic cells in amyotrophic lateral sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome.
Apoptosis will be measured by the reduction in propidium iodide-positive cells, expressed as a percentage of the total cells, in amyotrophic lateral sclerosis (ALS)-derived organoids treated with human amniotic mesenchymal stromal cell (hAMSC) secretome. The ability of the hAMSC secretome to restore ALS organoids (at least 5) to values close to healthy-donors organoids (at least 5) will be evaluated. The significance level is set at 0.05.
Measured: 24 months
Area measurement of damaged myelin in multiple sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome.
Reduction of demyelinated areas in multiple sclerosis (MS)-derived organoids treated with human amniotic mesenchymal stromal cell (hAMSC) secretome will be measured by the increase in mature oligodendrocyte markers relative to total section area. The ability of the hAMSC secretome to restore MS organoids (at least 5) to values close to healthy-donors organoids (at least 5) will be evaluated. The significance level is set at 0.05.
Measured: 24 months
Number of immunoregulatory microglial cells in multiple sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome.
The acquisition of an immunoregulatory phenotype will be determined in multiple sclerosis (MS)-derived organoids after treatment with human amniotic mesenchymal stromal cell (hAMSC) secretome by analyzing cells that are iNOS-negative, Arginase-positive, and HLA-DR low. Immunofluorescence analysis will count the number of cells positive for inflammatory/immunoregulatory markers out of total microglial IBA1+ cells. Fluorescence intensity changes will also be evaluated. The ability of the hAMSC secretome to restore MS organoids (at least 5) to values close to healthy-donors organoids (at least 5) will be evaluated. The significance level is set at 0.05.
Measured: 24 months
Secondary outcomes (1)
Percentage of altered immune phenotypic markers in amyotrophic lateral sclerosis and multiple sclerosis patients
The altered immune phenotype of peripheral blood mononuclear cells (PBMC) from patients with amyotrophic lateral sclerosis (ALS, n=15) and multiple sclerosis (MS, n=15) will be compared to age- and gender-matched healthy controls PBMC (n=30). Flow cytometry will be used to identify alteration in T and B lymphocytes, and monocytes and their subsets, including naïve and memory subsets, senescence status, expression of activation markers, and costimulatory molecules. The percentage of more than 40 markers will be considered and positive expression for each marker will be recorded. Immunophenotypic variation between patient PBMC and healthy control PBMC will be considered statistically significant with a p value < 0,05.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start17 Jan 2025
- Primary completion31 Mar 2026
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ornella Parolini, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551649
- Sponsor's protocol ID
- 6823
- Acronym
- CONTRASTOME
- Status last verified
- Sep 2026
- First submitted
- 16 Jul 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrasting Chronic Inflammation and Neurodegeneration Using the Human Amniotic Mesenchymal Cell Secretome as an Innovative Therapeutic Strategy
- ClinicalTrials.gov ID
- NCT06551649
- Acronym / sponsor ID
- CONTRASTOME / 6823
- Conditions
- Amyotrophic Lateral Sclerosis, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with amyotrophic lateral sclerosis | Experimental | Other: Venous blood draw and skin biopsyAmyotrophic 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. |
| Patients diagnosed with multiple sclerosis | Experimental | Other: Venous blood draw and skin biopsyMultiple 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. |
| Healthy volunteers, patients' unaffected spouses | Active comparator | Other: Venous blood draw and skin biopsySpouses 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous blood draw and skin biopsyThe 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. | Other | Healthy volunteers, patients' unaffected spouses, Patients diagnosed with amyotrophic lateral sclerosis, Patients diagnosed with multiple sclerosis |
Primary outcome
Neurite length measurement in a three-dimensional cellular model of amyotrophic lateral sclerosis.
Time frame: 18 months
Organoids from induced pluripotent stem cells (iPSCs) isolated from skin biopsies of 6 amyotrophic lateral sclerosis (ALS) patients and 6 healthy controls will be generated. Neurite degeneration will be measured in fluorescence microscopy as total βIII-TUBULIN-positive fiber length divided by the number of βIII-TUBULIN-positive cells in micrometers. Measurements will be taken from at least 5 ALS and 5 control organoids to analyze correlations and differences between groups. The significance level for statistical tests and models is set at 0.05.
Percentage of apoptotic cells in a three-dimensional cellular model of amyotrophic lateral sclerosis.
Time frame: 18 months
Organoids from induced pluripotent stem cells (iPSCs) isolated from skin biopsies of 6 amyotrophic lateral sclerosis (ALS) patients and 6 healthy controls will be generated. Apoptosis will be assessed by the percentage of propidium iodide-positive cells, representing the proportion of dead cells relative to the total number of cells. Measurements will be taken from at least 5 ALS and 5 control organoids to analyze correlations and differences between groups. The significance level for statistical tests and models is set at 0.05.
Area measurement of damaged myelin in a three-dimensional cellular model of multiple sclerosis.
Time frame: 18 months
Organoids from induced pluripotent stem cells (iPSCs) isolated from skin biopsies of 6 multiple sclerosis (MS) patients and 6 healthy controls will be generated. Myelin sheath damage will be assessed via immunofluorescence as the reduction in myelin marker-stained area versus total section area. Measurements will be taken from at least 5 MS and 5 control organoids to analyze correlations and differences between groups. The significance level for statistical tests and models is set at 0.05.
Number of inflamed microglial cells in a three-dimensional cellular model of multiple sclerosis.
Time frame: 18 months
Organoids from induced pluripotent stem cells (iPSCs) isolated from skin biopsies of 6 multiple sclerosis (MS) patients and 6 healthy controls will be generated. Microglial activation will be assessed by morphological variations, classifying cells as homeostatic, ramified, hyper-ramified, or amoeboid. Inflammatory microglia increase will be defined as the proportion of activated morphology cells relative to total cell count. Inflammatory markers HLA-DR and iNOS will be evaluated in terms of CD68 and IBA1 positive cells and fluorescence intensity. Measurements will be taken from at least 5 MS and 5 control organoids to analyze correlations and differences between groups. The significance level for statistical tests and models is set at 0.05.
Neurite length measurement in amyotrophic lateral sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome.
Time frame: 24 months
Neurite length in amyotrophic lateral sclerosis (ALS)-derived organoids treated with human amniotic mesenchymal stromal cell (hAMSC) secretome will be quantified using fluorescence microscopy as the total βIII-TUBULIN-positive fiber length divided by the number of βIII-TUBULIN-positive cells. The ability of the hAMSC secretome to restore ALS organoids (at least 5) to values close to healthy-donors organoids (at least 5) will be evaluated. The significance level is set at 0.05.
Percentage of apoptotic cells in amyotrophic lateral sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome.
Time frame: 24 months
Apoptosis will be measured by the reduction in propidium iodide-positive cells, expressed as a percentage of the total cells, in amyotrophic lateral sclerosis (ALS)-derived organoids treated with human amniotic mesenchymal stromal cell (hAMSC) secretome. The ability of the hAMSC secretome to restore ALS organoids (at least 5) to values close to healthy-donors organoids (at least 5) will be evaluated. The significance level is set at 0.05.
Area measurement of damaged myelin in multiple sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome.
Time frame: 24 months
Reduction of demyelinated areas in multiple sclerosis (MS)-derived organoids treated with human amniotic mesenchymal stromal cell (hAMSC) secretome will be measured by the increase in mature oligodendrocyte markers relative to total section area. The ability of the hAMSC secretome to restore MS organoids (at least 5) to values close to healthy-donors organoids (at least 5) will be evaluated. The significance level is set at 0.05.
Number of immunoregulatory microglial cells in multiple sclerosis organoids after treatment with human amniotic mesenchymal stromal cell secretome.
Time frame: 24 months
The acquisition of an immunoregulatory phenotype will be determined in multiple sclerosis (MS)-derived organoids after treatment with human amniotic mesenchymal stromal cell (hAMSC) secretome by analyzing cells that are iNOS-negative, Arginase-positive, and HLA-DR low. Immunofluorescence analysis will count the number of cells positive for inflammatory/immunoregulatory markers out of total microglial IBA1+ cells. Fluorescence intensity changes will also be evaluated. The ability of the hAMSC secretome to restore MS organoids (at least 5) to values close to healthy-donors organoids (at least 5) will be evaluated. The significance level is set at 0.05.
1 secondary outcome
Percentage of altered immune phenotypic markers in amyotrophic lateral sclerosis and multiple sclerosis patients
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ornella Parolini principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venous blood draw and skin biopsy in people with Amyotrophic Lateral Sclerosis and Multiple Sclerosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurite length measurement in a three-dimensional cellular model of amyotrophic lateral sclerosis. (time frame: 18 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.