The rising success of cell therapies places an increasing burden on health care costs. Consequently, the need to reduce production costs while maintaining quality has been widely acknowledged. In addition, the demand for high-quality products with an optimal safety profile is increasing. The proposed cell treatment is the first therapeutical option with the possibility to revert the underlying condition. The investigators expect that this healing response will be achieved with minimal side effects justifying the addional costs and complexity.
muscle precursor cells (MPCs) will be isolated from biopsies of the lower leg of patients, seeded, expanded and cultivated in vitro in a GMP facility to generate vital muscle cells dedicated for implantation. These muscle cells exhibit myogenic phenotype (IHC and flow cytometry) and therefore morphological and histological prerequisites approximating the properties of native skeletal muscle tissue. The muscle progenitor cells shall be applied in external sphincter muscle for the treatment of patients with stress urinary incontinence.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The advanced therapeutic investigational product, the MPCs, is a living, autologous cell-product isolated from a biopsy of the patient's own musculus soleus.
University Hospital Zurich
Zurich, Switzerland
Incidence of clinically relevant Adverse Events of MPCs or related to cell injection
Number of clinically relevant findings related to cell injection
Time frame: at 3 months post-implantation
Feasibility of MPC injection
Percentage of subjects with successful injection
Time frame: day of implantation
Efficacy of MPC injection measured by post-void residual volume
post-void residual volume
Time frame: at baseline, day of implantation, 1 month, 3 months and 6 months post-implantation
Efficacy of MPC injection measured by Uroflowmetry
Uroflowmetry: urinary flow pattern
Time frame: at baseline, day of implantation, 1 month, 3 months and 6 months post-implantation
Efficacy of MPC injection measured by Urodynamic Evaluation
2 Filling-Cystometries
Time frame: at baseline, 3 months and 6 months post-implantation
Efficacy of MPC injection measured by Urodynamic Evaluation
2 Pressure-Flow studies
Time frame: at baseline, 3 months and 6 months post-implantation
Efficacy of MPC injection measured by Urodynamic Evaluation
Urethal-Pressure-Profile
Time frame: at baseline, 3 months and 6 months post-implantation
Efficacy of MPC injection measured by 1h pad test
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1h pad test
Time frame: at baseline, 1 month, 3 months and 6 months post-implantation
Efficacy measured by average Incontinence Score
Incontinence Score. Range from 0 (no incentinence) to 21 (highly incontinent)
Time frame: at baseline, 1 month, 3 months and 6 months post-implantation
Efficacy measured by average score of Visual Analog Scale of degree of suffering
Visual Analog Scale of degree of suffering. Range 0 (worst) to 10 (best)
Time frame: at baseline, 1 month, 3 months and 6 months post-implantation
Efficacy measured by average score of Quality of Life
Quality of Life Score, using SF-36v2™ Health Survey
Time frame: at baseline, 1 month, 3 months and 6 months post-implantation
Efficacy
Number for (planned) subsequent incontinence surgery
Time frame: 6 months post-implantation
Number of patients with abnormal laboratory values and/or Adverse Events that are related to MPC injection
Safety measures (ultrasound, physical examination, laboratroy)
Time frame: at baseline, day of implantation, 1 month, 3 months and 6 months post-implantation