Multisystem Cell Therapy for Improvement of Urinary Continence

NCT03439527 | Completed Phase 1 DMC

• 2 other identifiers: H2020-SC1-2016-2017731377
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Stress Incontinence

Keywords

Muscle Precursor Cells

Outcome Measures

Primary Outcomes (1)

• Incidence of clinically relevant Adverse Events of MPCs or related to cell injection

  Number of clinically relevant findings related to cell injection

  at 3 months post-implantation

Secondary Outcomes (12)

• Feasibility of MPC injection

  day of implantation

• Efficacy of MPC injection measured by post-void residual volume

  at baseline, day of implantation, 1 month, 3 months and 6 months post-implantation

• Efficacy of MPC injection measured by Uroflowmetry

  at baseline, day of implantation, 1 month, 3 months and 6 months post-implantation

• Efficacy of MPC injection measured by Urodynamic Evaluation

  at baseline, 3 months and 6 months post-implantation

• Efficacy of MPC injection measured by Urodynamic Evaluation

  at baseline, 3 months and 6 months post-implantation

Study Arms (2)

MPC-group

EXPERIMENTAL

All patients are treated by the same product: Autologous MPCs

Other: Muscle Precursor Cells (MPCs), ATMP

NMES+MPC-group

OTHER

After treatment, the patients will be randomized 1:1 in the MPC-group or NMES+MPC-group to investigate the benefits of an additional physiotherapy (Neuromuscular Electromagnetic Stimulation, NMES)

Other: Muscle Precursor Cells (MPCs), ATMP

Interventions

Muscle Precursor Cells (MPCs), ATMP OTHER

The advanced therapeutic investigational product, the MPCs, is a living, autologous cell-product isolated from a biopsy of the patient's own musculus soleus.

MPC-group; NMES+MPC-group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Gender Eligibility Details: due to injection technique
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult women 20y-60y
• Incontinence \>/= grade I since at least 6 months
• Predominant clinical diagnosis of SUI
• Candidate for a surgical treatment (artificial urinary sphincter, synthetic compressive tapes or adjustable balloons).
• Can independently use toilet without difficulty
• Capacity to answer the questionnaires of evaluation
• Negative blood test for: Human immunodeficiency virus (HIV 1/2), Hepatitis B HBsAg, Anti HBc, Hepatitis C Anti-HCV-Ab, Syphilis
• Competent to comprehend, sign and date informed consent form before any study-specific procedure is performed

You may not qualify if:

• History of anti-incontinence or prolapse surgery.
• Previous diagnosis of any of the following conditions, disorders, or diseases of the urinary tract:
• Clinically significant cystocele or rectocele
• Ureteric bladder, urethral or rectal fistula
• Uncorrected congenital abnormality leading to urinary incontinence
• Interstitial cystitis
• Urinary urgency that results in leakage (as a predominant symptom)
• Adult enuresis
• Urodynamically proven detrusor instability
• Sensory urgency defined as first sensation of bladder fill (urge to void) of \<100 ml; bladder capacity of \<300 ml
• No sensation at any time during the simple filling cystometry procedure
• Known urethral stenosis (ureterocystoscopy) or urethral diverticulum
• History of urogenital cancer or history of pelvic radiotherapy
• Women who are pregnant, breast feeding or \<12 months postpartum Note: Female subjects who are surgically sterilized, hysterectomized or post-menopausal for longer than 2 years are not considered as having child bearing potential. No pregnancy test will be performed for this population.
• Untreated symptomatic urinary tract infection

Sponsors & Collaborators

• University of Zurich: lead
• University Hospital Tuebingen: collaborator
• Salzburger Landeskliniken: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

cyclic adenosine-5'-trimetaphosphate

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Eberli, Prof

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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) 40 female patients suffering from urinary incontinence since at least 6 months (predominant clinical diagnosis of SUI) and who are candidate for a surgical treatment will be included . All patients are treated by the same product: Autologous MPCs. After treatment, the patients will be randomized 1:1 in the MPC-group or NMES+MPC-group to investigate the benefits of an additional physiotherapy.

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: February 20, 2018
• Study Start: January 22, 2020
• Primary Completion: September 3, 2021
• Study Completion: October 21, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)