Skeletal muscle-derived cell implantation in female patients with stress urinary incontinence: a multinational and multicenter open follow-up study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001656-34-BG

Enrollment

Registered

2014-06-13

Start date

2014-10-01

Completion date

Unknown

Last updated

2016-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress urinary incontinence (SUI) in female patients of moderate severity (Grade 2 and Grade 3) MedDRA version: 17.1 Level: PT Classification code 10066218 Term: Stress urinary incontinence System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Product Name: Skeletal Muscie Derived Cells Product Code: ICES13 Pharmaceutical Form: Suspension for injection in cartridge

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who participated in the phase II study IC-01-01-04-003 “SUITE”, 2. Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 78 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1. Evidence of uncooperative attitude, 2. Patients who, according to the clinical judgment of the investigator, are not suitable for this study

Design outcomes

Primary

Measure	Time frame
Main Objective: To show the long term efficacy and safety of the skeletal muscle-derived cell therapy;Secondary Objective: not applicable;Primary end point(s): Change in the Incontinence Episode Frequency (IEF) score compared to pre-treatment baseline measured in predecessor phase II study IC-01-01-04-003 “SUITE”;Timepoint(s) of evaluation of this end point: The study includes two visits (visit 1 and visit 2, minimum one week after visit 1). Period per patie: 1 week	—

Measure

Time frame

Main Objective: To show the long term efficacy and safety of the skeletal muscle-derived cell therapy;Secondary Objective: not applicable;Primary end point(s): Change in the Incontinence Episode Frequency (IEF) score compared to pre-treatment baseline measured in predecessor phase II study IC-01-01-04-003 “SUITE”;Timepoint(s) of evaluation of this end point: The study includes two visits (visit 1 and visit 2, minimum one week after visit 1). Period per patie: 1 week

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Secondary

Measure	Time frame
Secondary end point(s): Efficacy variables • I-QoL score, • VAS score, • Examinations based on the micturition diary records, • Investigator’s assessment by CGI score, • Patient’s assessment by PGI Safety variables • Adverse events, • Safety laboratory measurements, vital signs, physical examinations. ;Timepoint(s) of evaluation of this end point: The study includes two visits (visit 1 and visit 2, minimum one week after visit 1). Period per patient: 1 week	—

Measure

Time frame

Secondary end point(s): Efficacy variables • I-QoL score, • VAS score, • Examinations based on the micturition diary records, • Investigator’s assessment by CGI score, • Patient’s assessment by PGI Safety variables • Adverse events, • Safety laboratory measurements, vital signs, physical examinations. ;Timepoint(s) of evaluation of this end point: The study includes two visits (visit 1 and visit 2, minimum one week after visit 1). Period per patient: 1 week

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Countries

Bulgaria

Contacts

Public ContactBCCR Ltd

Bulgarian Centers for Clinical Research Ltd

office@bccr.eu35929504630

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026