Osmotin Plant Protein for 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
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Osmotin
What it measured
Main measures
Incidence and severity of treatment-related adverse events after 1 month of therapy.
1 month (after 1 month of treatment).
SafetyIncidence and severity of treatment-related adverse events after 6 months of therapy.
6 months (after 6 months of treatment).
Safety
Other measures (13)
Change in Expanded Disability Status Scale (EDSS).
12 months (6 month before starting treatment, at baseline and both after one month and six months of treatment)
Disability progressionChange in Timed 25 Foot Walk (T25FW).
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
Disability progressionWalking and mobilityChange in 12-item Multiple Sclerosis Walking Scale (MSWS12).
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
Walking and mobilityChange in Nine-Hole Peg Test (9HPT).
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
Disability progressionArm and hand functionChange in Montreal Cognitive Assessment (MOCA).
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
Thinking and memoryChange in Symbol Digit Modalities Test (SDMT).
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
Thinking and memoryChange in patient self-evaluation of depression and anxiety recorded with Hospital Anxiety Depression Scale (HADS).
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
Mood and sleepChange in bladder domain function recorded with Overactive Bladder (OAB) questionnaire.
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
Bladder, bowel and sexual functionThe impact of Forza™️ on neurophysiology in PMS.
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
Myelin repairNerve conduction testsThe impact of Forza™️ on retinal atrophy in PMS.
12 months (6 months before starting treatment, at baseline and both after one month and six months of treatment)
Brain volume lossRetina scans (OCT)
Who could take part
Progressive MS · 18 to 70
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Study protocol: Exploratory trial of Forza™, an osmotin-based nutraceutical as adjuvant for the treatment of progressive multiple sclerosis.PLoS One · 2025
Background
Dangond F, Donnelly A, Hohlfeld R, Lubetzki C, Kohlhaas S, Leocani L, Ciccarelli O, Stankoff B, Sormani MP, Chataway J, Bozzoli F, Cucca F, Melton L, Coetzee T, Salvetti M. Facing the urgency of therapies for progressive MS - a Progressive MS Alliance proposal. Nat Rev Neurol. 2021 Mar;17(3):185-192. doi: 10.1038/s41582-020-00446-9. Epub 2021 Jan 22.Background
University of California, San Francisco MS-EPIC Team; Cree BAC, Hollenbach JA, Bove R, Kirkish G, Sacco S, Caverzasi E, Bischof A, Gundel T, Zhu AH, Papinutto N, Stern WA, Bevan C, Romeo A, Goodin DS, Gelfand JM, Graves J, Green AJ, Wilson MR, Zamvil SS, Zhao C, Gomez R, Ragan NR, Rush GQ, Barba P, Santaniello A, Baranzini SE, Oksenberg JR, Henry RG, Hauser SL. Silent progression in disease activiBackground
Kappos L, Wolinsky JS, Giovannoni G, Arnold DL, Wang Q, Bernasconi C, Model F, Koendgen H, Manfrini M, Belachew S, Hauser SL. Contribution of Relapse-Independent Progression vs Relapse-Associated Worsening to Overall Confirmed Disability Accumulation in Typical Relapsing Multiple Sclerosis in a Pooled Analysis of 2 Randomized Clinical Trials. JAMA Neurol. 2020 Sep 1;77(9):1132-1140. doi: 10.1001/jBackground
Green AJ. Potential Benefits of Early Aggressive Treatment in Multiple Sclerosis. JAMA Neurol. 2019 Mar 1;76(3):254-256. doi: 10.1001/jamaneurol.2018.4932. No abstract available.Background
Singh NK, Bracker CA, Hasegawa PM, Handa AK, Buckel S, Hermodson MA, Pfankoch E, Regnier FE, Bressan RA. Characterization of osmotin : a thaumatin-like protein associated with osmotic adaptation in plant cells. Plant Physiol. 1987 Oct;85(2):529-36. doi: 10.1104/pp.85.2.529.Background
Narasimhan ML, Coca MA, Jin J, Yamauchi T, Ito Y, Kadowaki T, Kim KK, Pardo JM, Damsz B, Hasegawa PM, Yun DJ, Bressan RA. Osmotin is a homolog of mammalian adiponectin and controls apoptosis in yeast through a homolog of mammalian adiponectin receptor. Mol Cell. 2005 Jan 21;17(2):171-80. doi: 10.1016/j.molcel.2004.11.050.Background
Carbone F, La Rocca C, Matarese G. Immunological functions of leptin and adiponectin. Biochimie. 2012 Oct;94(10):2082-8. doi: 10.1016/j.biochi.2012.05.018. Epub 2012 Jun 26.Background
Takahashi Y, Watanabe R, Sato Y, Ozawa N, Kojima M, Watanabe-Kominato K, Shirai R, Sato K, Hirano T, Watanabe T. Novel phytopeptide osmotin mimics preventive effects of adiponectin on vascular inflammation and atherosclerosis. Metabolism. 2018 Jun;83:128-138. doi: 10.1016/j.metabol.2018.01.010. Epub 2018 Feb 2.Background
Liu J, Sui H, Zhao J, Wang Y. Osmotin Protects H9c2 Cells from Simulated Ischemia-Reperfusion Injury through AdipoR1/PI3K/AKT Signaling Pathway. Front Physiol. 2017 Sep 25;8:611. doi: 10.3389/fphys.2017.00611. eCollection 2017.
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History
Started
Jan 2023
Main results due
Jan 2024
Finished
Jan 2025