Skeletal Muscle-derived Cell Implantation for the Treatment of Fecal Incontinence: a Phase III, Randomized, Controlled, Double Blind, Two Armed Clinical Study

The objective of this study is the final assessment of clinical safety and efficacy of autologous autologous skeletal muscle derived cells for patients with urge fecal incontinence due to external anal sphincter dysfunction caused by its disruption and/or weakness.

Start Date11 May 2022

Sponsor / Collaborator

Innovacell GmbH

100 Clinical Results associated with ICEF-15

100 Translational Medicine associated with ICEF-15

100 Patents (Medical) associated with ICEF-15

Literatures (Medical) associated with ICEF-15

01 May 2022·International Journal of Gynecology & ObstetricsQ4 · MEDICINE

The effect of skeletal muscle‐derived cells implantation on stress urinary incontinence and functional urethral properties in female patients

Q4 · MEDICINE

Article

Author: Lukanović, Adolf ; Blaganje, Mija

AbstractObjectiveTo evaluate improvement of stress urinary incontinence (SUI) and functional status of the urethra after autologous skeletal‐muscle derived cell (aSMDC) implantation.MethodsPhase I–II, open, non‐randomized, single‐center study of ultrasound guided aSMDC implantation (dosed at 0.2 × 106 cells/2 mL) into the external urethral sphincter to treat SUI.ResultsA total of 38 patients were treated and followed for 2 years. SUI measured by Incontinence Episode Frequency score, short pad test, quality of life, patient's and clinician's perception significantly improved and remained improved after 2 years. However, urodynamic urethral properties in general did not improve at 1‐year after treatment. Subgroup analysis revealed that addition of an adjuvant functional electrical stimulation therapy discontinued 4 weeks after injection in the compliant group, gave better urodynamic values and maintained the long‐term SUI improvement at 2 years.ConclusionThe aSMDC injection was safe and well‐tolerated by patients. The status of SUI improved and with it the quality of life of patients, even if this was not necessarily reflected in the urodynamic urethral properties. Electrical stimulation, as an adjuvant therapy, could have an essential role in the success of the therapy.Clinical registrationClinical study was registered under Eudra‐CT number: 2010‐021867‐34 at European Clinical Trial Database (EudraCT), accessible at: EudraCT (europa.eu).

100 Deals associated with ICEF-15

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Indication	Highest Phase	Country/Location	Organization	Date
Fecal Incontinence	Phase 3	Japan	Innovacell GmbH	11 May 2022
Fecal Incontinence	Phase 3	Italy	Innovacell GmbH	11 May 2022
Fecal Incontinence	Phase 3	Poland	Innovacell GmbH	11 May 2022
Fecal Incontinence	Phase 3	Czechia	Innovacell GmbH	11 May 2022
Fecal Incontinence	Phase 3	United Kingdom	Innovacell GmbH	11 May 2022
Fecal Incontinence	Phase 3	Austria	Innovacell GmbH	11 May 2022
Fecal Incontinence	Phase 3	Bulgaria	Innovacell GmbH	11 May 2022
Fecal Incontinence	Phase 3	France	Innovacell GmbH	11 May 2022
Fecal Incontinence	Phase 3	Germany	Innovacell GmbH	11 May 2022
Fecal Incontinence	Phase 3	Sweden	Innovacell GmbH	11 May 2022

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