Compositions and methods for treating and repairing tendons
Inventors
Hoffmann, Rolf • McElwee, Kevin John
Assignees
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Publication Number
US-10272118-B2
Publication Date
2019-04-30
Expiration Date
Abstract
The present invention relates to compositions and methods utilizing hair follicle derived Non-Bulbar Dermal Sheath cells for use in the treatment or prevention of the tendon injuries.
Core Innovation
The invention relates to a method for treating a tendon injury by administering to a subject in need thereof a composition comprising isolated non-bulbar dermal sheath (NBDS) cells. The method is directed to tendon injuries including tendon rupture, tendon tear, and microtears. The NBDS cells are derived from hair follicle-derived material and provided as an isolated cell product within a therapeutic composition.
A core aspect is the production of isolated NBDS cells using a defined workflow starting from vital hair. The method includes cleaving vital hair to remove the hair follicle bulb and obtain an isolated dermal sheath, isolating NBDS tissue from the dermal sheath, and cultivating the isolated NBDS tissue to produce the isolated NBDS cells. This ties the therapeutic cell product to a specific origin in non-bulbar dermal sheath tissue generated from vital hair.
The disclosed compositions for administration can include formats that involve serum/plasma or combinations with biomaterials, including fibrin and hyaluronic materials, and can also be serum/plasma-free. The compositions may further include selected extracellular matrix components, cytokines, chemokines, and therapeutic agents such as analgesic, anti-inflammatory, and immunomodulatory agents. The document also describes characterization concepts for NBDS cells using cell markers and controlling keratinocytes/melanocytes contamination.
Claims Coverage
The independent claim provides a treatment method that includes administering isolated NBDS cells for a tendon injury and producing those NBDS cells through a vital hair-to-cleaved dermal sheath-to-isolated NBDS tissue-to-cultivation workflow. Across the claims, inventive features span production, composition, and treatment scope.
Treating a tendon injury with isolated NBDS cells
A method for treating a tendon injury comprising administering to a subject in need thereof a composition comprising isolated non-bulbar dermal sheath (NBDS) cells.
Producing isolated NBDS cells from vital hair by cleaving and cultivating
The isolated NBDS cells are produced by preparing vital hair, cleaving the vital hair to remove the hair follicle bulb and obtain an isolated dermal sheath, isolating NBDS tissue from the dermal sheath, and cultivating the isolated NBDS tissue to produce the isolated NBDS cells.
Producing NBDS cells by enzymatic digestion of isolated NBDS tissue
The method includes producing isolated NBDS cells by enzymatically digesting isolated Non-Bulbar Dermal Sheath tissue.
Enzymatic digestion using collagenase
The method is carried out by performing enzymatic digestion using collagenase.
Tendon injury selected from complete rupture, partial rupture, or micro-tear
The tendon injury is selected from a complete tendon rupture, a partial tendon rupture, or a tendon micro-tear.
Serum/plasma exclusion in the administered composition
The composition does not contain serum or plasma.
Administered composition further including selected components
The composition further includes at least one selected component from fibrin, hyaluronic acid, an extracellular matrix component, cytokine, chemokine, and/or a therapeutic agent.
Overall, the claims center on administering isolated NBDS cells produced from vital hair through cleaving to remove the hair follicle bulb, isolating NBDS tissue, and cultivating to generate NBDS cells. The claims also refine the production by enzymatic digestion, including collagenase, and specify tendon injury categories and composition features including serum/plasma-free and component-containing formats.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treating a tendon injury in a subject by administering a composition comprising isolated NBDS cells.
Tendon injury indications described include complete tendon rupture, partial tendon rupture, and tendon micro-tear, including tendon rupture/tear and microtears.
Documented experimental context describes in vitro tendon stretch/collagen (Type I) production evidence from NBDS/plasma gels with mechanical stretching.
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