NCT03439527

Multisystem Cell Therapy for Improvement of Urinary Continence

Open-label, Monocentric, First-in-man Trial to Assess Safety and Tolerability of a New Therapeutic Strategy for Stress Urinary Incontinence Based on the Implantation of Muscle Precursor Cells (MPCs)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: Female
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Urinary Stress Incontinence

Interventions

Type	Name	Description
OTHER	Muscle Precursor Cells (MPCs), ATMP	The advanced therapeutic investigational product, the MPCs, is a living, autologous cell-product isolated from a biopsy of the patient's own musculus soleus.

Timeline

• Start date: 2020-01-22
• Primary completion: 2021-09-03
• Completion: 2021-10-21
• First posted: 2018-02-20
• Last updated: 2021-11-03

Locations

1 site across 1 country: Switzerland