Exploring the effects of osmotin plant protein in progressive multiple sclerosis
Exploratory Trial of Forza™️, a Novel Nutraceutical From Actinidia Deliciosa Plants Bioengineered to Bio-encapsulate the Osmotin Plant Protein as Adjuvant for the Treatment of Progressive Multiple Sclerosis
NA · Ospedale Policlinico San Martino · NCT05937802
This study is testing if a new plant protein called osmotin can help people with progressive multiple sclerosis by reducing inflammation and protecting their nerves.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Ospedale Policlinico San Martino (other) |
| Locations | 2 sites (Genova and 1 other locations) |
| Trial ID | NCT05937802 on ClinicalTrials.gov |
What this trial studies
This study investigates the anti-inflammatory and neuroprotective properties of a novel nutraceutical product, Forza™️, which contains the plant protein osmotin, in patients diagnosed with progressive multiple sclerosis (PMS). Participants will undergo magnetic resonance imaging (MRI) to assess brain metabolism and microstructure at various time points: six months prior to treatment, at baseline, and after one and six months of treatment. Additionally, clinical assessments, electrophysiology tests, and neurofilament quantification will be conducted to evaluate the treatment's efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with progressive multiple sclerosis and an Expanded Disability Status Scale (EDSS) score of 6.5 or lower.
Not a fit: Patients with contraindications to MRI, those who are pregnant, or individuals with severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for managing symptoms and slowing the progression of multiple sclerosis.
How similar studies have performed: While the specific use of osmotin in this context is novel, similar studies exploring plant-based nutraceuticals for neurological conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed written informed consent * Diagnosis of progressive multiple sclerosis (PMS) * Expanded Disability Status Scale EDSS ≤ 6.5 Exclusion Criteria: * Contraindications to MRI * Pregnancy * HIV positivity * Severe renal, hepatic, oncological, hematological and psychiatric diseases
Where this trial is running
Genova and 1 other locations
- IRCCS Ospedale Policlinico San Martino — Genova, Italy (RECRUITING)
- Azienda Ospedaliera Universitaria Sant'Andrea — Roma, Italy (RECRUITING)
Study contacts
- Study coordinator: Matilde Inglese
- Email: m.inglese@unige.it
- Phone: 0103537028
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Progressive Multiple Sclerosis, Osmotin