Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT05534269
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2022-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stress Urinary Incontinence Study to Assess Safety and Efficacy of Muvon's Muscle Precursor Cell Therapy
Sponsor:
University of Zurich
Organization:
Study Overview
Official Title:
Stress Urinary Incontinence Study to Assess Safety and Efficacy of Muvon's Muscle Precursor Cell Therapy
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUISSE MPC2
Brief Summary:
The objective of the SUISSE MPC 2 study is to treat stress urinary incontinence in adult women.
Detailed Description:
Stress urinary incontinence (SUI) is the loss of small amounts of urine associated with coughing, laughing, sneezing, exercising or other activities that increase pressure on the abdomen and, subsequently, the bladder.
The goal of the SUISSE MPC2 study is to treat SUI in women using their own autologous muscle precursor cells. To generate enough outcome data, a sufficient number of patients will be enrolled to yield evaluable data from 30 patients.
The study will be conducted as a self-controlled case series (SCCS) with each patient serving as their own comparators. Patients will participate in the study for up to approximately 8 to 9 months, including a baseline visit for screening, a visit to obtain a muscle biopsy approximately 12 weeks later, an injection of MPCCOLs up to 5 weeks later, and follow-up visits at 1, 3 and 6 months post injection. The injection is performed with ultrasound guidance using an endocavity ultrasound probe mounted on an Injection Device specifically designed for the clinical trial.
All patients will be treated with one of two doses of MPCCOL, assigned according to the study's randomization method.
Half of the participating patients will receive the tissue engineered product (TEP) dose that was previously studied in the completed phase I study. The other half of the participants will receive a higher dose of the cell therapy to investigate the effects of dose increase. All study participants will be monitored via medical examinations.
Separate from the Principal Investigator, safety events will be reported to and investigated by an independent Data Safety Monitoring Board (DSMB) consisting of independent physicians and experts in the field. Data regarding the functionality and safety of the Injection Device will also be collected.
The goal of the SUISSE MPC2 study is to treat SUI in women using their own autologous muscle precursor cells. To generate enough outcome data, a sufficient number of patients will be enrolled to yield evaluable data from 30 patients.
The study will be conducted as a self-controlled case series (SCCS) with each patient serving as their own comparators. Patients will participate in the study for up to approximately 8 to 9 months, including a baseline visit for screening, a visit to obtain a muscle biopsy approximately 12 weeks later, an injection of MPCCOLs up to 5 weeks later, and follow-up visits at 1, 3 and 6 months post injection. The injection is performed with ultrasound guidance using an endocavity ultrasound probe mounted on an Injection Device specifically designed for the clinical trial.
All patients will be treated with one of two doses of MPCCOL, assigned according to the study's randomization method.
Half of the participating patients will receive the tissue engineered product (TEP) dose that was previously studied in the completed phase I study. The other half of the participants will receive a higher dose of the cell therapy to investigate the effects of dose increase. All study participants will be monitored via medical examinations.
Separate from the Principal Investigator, safety events will be reported to and investigated by an independent Data Safety Monitoring Board (DSMB) consisting of independent physicians and experts in the field. Data regarding the functionality and safety of the Injection Device will also be collected.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: