Osmotin Plant Protein for Progressive Multiple Sclerosis

Ospedale Policlinico San Martino

Status: Enrolling

Conditions: Progressive Multiple Sclerosis

Treatments: Dietary Supplement: Osmotin

Study type: Interventional

Funder types: Other

Identifiers

NCT05937802

12042 (Registry Identifier)

Details and patient eligibility

About

The aim of this study is to explore the anti-inflammatory and neuroprotective effects of a novel nutraceutical product (commercial name Forza™️), consisting of the plant osmotin protein, in patients with progressive multiple sclerosis (PMS). The potential effect on brain metabolism and microstructure will be evaluated by magnetic resonance imaging (MRI) performed six months before starting treatment, at baseline, and after one and six months of treatment. At the same timepoints, electrophysiology, neurofilaments (NfL) quantification, optical coherence tomography (OCT) and clinical assessments will be performed.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Osmotin

Experimental group

Description:

Administration of a nutraceutical supplement provided in capsules, that consists of lyophilised and pulverised kiwi leaves from bioengineered kiwi (Actinidia Deliciosa) plants overexpressing the tobacco protein Osmotin.

Treatment:

Dietary Supplement: Osmotin