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pp-092

Injection

Dossier type
EU CTD
Dossier status
Under development
Country of origin
Japan
GMP approvals
EU GMP
Comments
Indication: Stress urinary incontinence from sphincter weakness or injury causing involuntary urine loss during exertion; for patients not adequately managed by conservative therapy, medication, surgery, or devices. Clinical stage: Multiple Phase I/II trials completed; Phase IIb in 2010–2011; large multinational Phase III study; data from 32 clinics in seven countries. Modality: Autologous cell therapy. Mechanism / Target: Injection of expanded skeletal muscle cells into the urethral sphincter to regenerate and restore muscle function. Route / form: Local injection into the urethral sphincter. Differentiation: First regenerative cell therapy program globally to reach advanced-stage clinical development for stress urinary incontinence; designed to provide long-term functional sphincter restoration, overcoming limitations of conservative treatments, pharmacotherapy, surgical procedures, and devices; supported by extensive multinational clinical experience.
Manufacturer #38642

A clinical-stage biotechnology firm developing regenerative cell therapies to treat fecal and urinary incontinence by restoring sphincter muscle function rather than just managing symptoms. It advances proprietary autologous cell therapy programs through multinational Phase III clinical development with global strategic aims. The organization combines R&D, manufacturing and clinical expertise to address high unmet needs.

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