Human Amniotic Mesenchymal Cell Secretome for Neurodegeneration and Neuroinflammation

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Aug 9, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for neurodegenerative diseases, specifically amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). The researchers are studying the secretome, which is a mixture of substances released by human amniotic mesenchymal stromal cells (hAMSC), to see if it can help reduce inflammation and support the repair of nerve cells in the brain and spinal cord. By using special three-dimensional models that mimic the conditions of these diseases, the study aims to understand how this treatment might work in a lab setting before moving on to human trials.

To participate in this study, patients with ALS should be between 50 and 60 years old, while those with MS should be between 20 and 50 years old and have recently received a diagnosis. Healthy volunteers, ideally spouses of the patients, are also needed and should be of similar age and gender. Participants will provide blood samples and skin biopsies to help researchers create models that resemble the complex interactions within the nervous system. It’s important to note that patients who have recently been treated for their conditions or who don’t agree to take part will not be included. This study is still in the planning stages and has not started recruiting participants yet.

Gender

ALL

Eligibility criteria

• 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.