Blood plasma fractions for use in muscle regeneration
Inventors
Kheifets, Viktoria • Lu, Benson • Tennstaedt, Annette
Assignees
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Publication Number
US-11439687-B2
Publication Date
2022-09-13
Expiration Date
Abstract
Methods and compositions for treating aging-related diseases as well as muscle recovery, prevention of muscle degeneration, and maintenance of muscle are described. The compositions used in the methods include blood plasma and blood plasma fractions derived from blood plasma with efficacy in treating and/or preventing disease.
Core Innovation
Plasma-derived fraction products are provided for improving skeletal muscle regeneration and for treating and/or preventing muscle degeneration and injury. The document connects these plasma fractions to muscle disorder symptom reduction, including aging-related sarcopenia and dystrophies. The described approach is grounded in regenerative biology involving satellite cells and muscle regenerative processes.
The invention focuses on plasma fractionation to obtain plasma protein fraction (PPF) defined by specific albumin/globulin composition ranges. The document describes a PPF containing between 83% and 95% albumin, no more than 17% globulin, and no more than 1% gamma globulin, and it also describes additional fractionation streams and effluents with reduced clotting factors and/or altered protein composition, including protein-enriched plasma protein products.
The document further associates the plasma fraction products with observed functional and molecular effects in vitro and in vivo. These effects include increased muscle mass and enhanced slow-twitch gene expression, improved twitch force after injury, and elevated serum IGF-1, along with reduced age-related cardiac hypertrophy markers associated with the plasma fraction products. The document also describes pulsed-dosing concepts and broad treatment indications for muscle disorders.
Claims Coverage
The independent claim set centers on administering a plasma-derived Plasma Fraction that is a Plasma Protein Fraction (PPF) defined by albumin/globulin composition, with multiple dependent claims refining the muscle disorder scope and the administration format. Across the family, at least four main inventive feature areas are explicitly stated: the specific PPF composition limits, improving muscle regeneration, targeting symptom reduction in subjects diagnosed with a muscle disorder, and optionally applying pulse dosing and/or narrowing to dystrophy subtypes and additional enumerated muscle disorders.
Albumin-defined plasma protein fraction composition limits
Administering a Plasma Fraction that is a Plasma Protein Fraction (PPF) containing between 83% and 95% albumin, no more than 17% globulin and no more than 1% gamma globulin.
Improving muscle regeneration to reduce muscle disorder symptoms
Administering an effective amount of the defined Plasma Fraction to improve muscle regeneration thereby reducing symptoms of a muscle disorder in a subject diagnosed with the muscle disorder.
Pulse dose administration regimen
Performing the method by administering the treatment using a Pulse Dose dosing regimen.
Dystrophy scope as the muscle disorder
Where the muscle disorder is a dystrophy.
Specific dystrophy subtypes
Where the dystrophy is selected from Duchenne, Becker, myotonic, limb girdle, Emery-Dreifuss, congenital muscular, or facioscapulohumeral muscular dystrophy.
Enumerated muscle disorder types beyond dystrophy
Carrying out the method for a muscle disorder selected from a group including muscle atrophy, muscle weakness, McArdle disease, muscle weakness associated with stroke, degeneration associated with amyotrophic lateral sclerosis, neuromuscular junction disorders, myasthenia gravis, toxic myopathy, inflammatory myopathy, lipid storage myopathy, ischemia, and contraction-induced damage.
Symptom reduction by eliminating symptoms
Including eliminating symptoms of a muscle disorder to reduce the disorder’s symptoms.
Claim coverage is anchored on administration of an effective amount of an albumin/globulin-defined plasma protein fraction (PPF) to improve muscle regeneration and reduce muscle disorder symptoms, with dependent features narrowing to dystrophy (including specified dystrophy subtypes), expanding to additional enumerated muscle disorder categories, and optionally specifying a pulse dose administration regimen and symptom elimination.
Stated Advantages
Improving muscle regeneration.
Reducing symptoms of a muscle disorder.
Treating and/or preventing muscle degeneration and injury, including aging-related sarcopenia and dystrophies.
Symptom reduction framed as eliminating symptoms of a muscle disorder.
Documented Applications
Treating and/or preventing muscle degeneration and injury in contexts including aging-related sarcopenia and dystrophies.
Improving skeletal muscle regeneration and reducing symptoms of a muscle disorder in a subject diagnosed with the muscle disorder.
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