Methods for treating genitourinary disorders
Inventors
Damaser, Margot S. • Dissaranan, Charuspong • Goldman, Howard B. • Kiedrowski, Matthew • Penn, Marc S.
Assignees
Cleveland Clinic Foundation • US Department of Veterans Affairs
Publication Number
US-9782440-B2
Publication Date
2017-10-10
Expiration Date
2033-02-19
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Abstract
One aspect of the present disclosure can include a therapeutic composition useful for treatment of a genitourinary disorder. The composition can be derived from a culture media having been in contact with a population of bone marrow-derived mesenchymal stem cells for a sufficient time period necessary to endow therapeutic activity in the culture media. The therapeutic property endowed to the culture media is the ability to promote structural and functional recovery of a dysfunctional organ or biological tissue associated with the genitourinary disorder.
Core Innovation
The invention provides a therapeutic composition derived from culture media previously in contact with bone marrow-derived mesenchymal stem cells (MSCs) for a sufficient period to endow the media with therapeutic activity. This therapeutic property is the ability to promote structural and functional recovery of organs or biological tissues associated with genitourinary disorders.
The invention also discloses methods for treating or preventing genitourinary disorders by administering either a therapeutically effective amount of bone marrow-derived MSCs or a therapeutically effective amount of concentrated culture media derived from such MSCs to a subject. The MSCs can home to target organs associated with the disorder and promote repair via secretion of paracrine factors, while the concentrated culture media provides similar therapeutic effects through these secreted factors without requiring administration of viable cells.
The problem being solved is that current treatments for genitourinary disorders, such as stress urinary incontinence (SUI), often address symptoms but do not repair underlying pathophysiology. For example, surgery can improve symptoms of SUI but does not restore the damaged tissues caused by childbirth. The invention aims to provide effective noninvasive treatments that promote the repair and functional recovery of damaged genitourinary tissues, thereby addressing the underlying cause of disorders like SUI.
Claims Coverage
The patent includes one independent claim describing a method involving bone marrow-derived mesenchymal stem cells and concentrated culture media for treatment of genitourinary disorders. The inventive features relate to culture, preparation, and administration of the concentrated culture media substantially free of MSCs.
Method for treating genitourinary disorder with concentrated culture media
A method comprising culturing a population of bone marrow-derived mesenchymal stem cells (MSCs), obtaining a concentrated culture media from the cultured MSCs substantially free of MSCs, and administering a therapeutically effective amount of this concentrated culture media to a subject.
Culturing conditions to promote paracrine factor secretion
The culturing step is conducted for a time and under conditions sufficient to promote secretion of extracellular proteins and cellular metabolites which support growth of the MSC population and endow therapeutic activity to the culture media.
Concentration of culture media
The culture media is concentrated at least about 10-fold, and in some embodiments at least about 50-fold, to enrich therapeutic factors before administration.
Administration at or near target location
The therapeutically effective amount of the concentrated culture media is administered at or near a target location associated with the genitourinary disorder, such as via periurethral injection.
Treatment of various genitourinary disorders
The method is applicable to treating disorders including urinary incontinence, stress urinary incontinence, overactive bladder, pelvic organ prolapse, interstitial cystitis, incontinence following prostatectomy, fecal incontinence, and erectile dysfunction.
The claims cover the inventive method of treating genitourinary disorders by administering a therapeutically effective amount of concentrated culture media derived from cultured bone marrow-derived MSCs. The method emphasizes culturing conditions, concentration of media, delivery at relevant target sites, and application to various genitourinary conditions.
Stated Advantages
Bone marrow-derived MSCs injected intravenously promote recovery of urethral structure and function in genitourinary disorders.
Proteins secreted by bone marrow-derived MSCs can elicit similar improvements as cell administration, allowing for treatment with concentrated culture media without risks of unwanted cell differentiation or neoplasms.
The methods provide a noninvasive approach to treating genitourinary disorders through paracrine factor-mediated repair and regeneration of damaged tissues.
Using concentrated culture media enables scalable, off-the-shelf therapeutic formulations that avoid the complexities of cell harvesting and expansion from patients.
Documented Applications
Treatment of stress urinary incontinence caused by childbirth by administering bone marrow-derived MSCs or concentrated culture media to promote structural and functional urethral recovery.
Treatment or prevention of genitourinary disorders including urinary incontinence, overactive bladder, pelvic organ prolapse, interstitial cystitis, incontinence after prostatectomy, fecal incontinence, and erectile dysfunction.
Use as a noninvasive therapy for urethral and pelvic floor disorders by injecting concentrated culture media or MSCs to induce tissue repair via paracrine effects.
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