Multisystem Cell Therapy for Improvement of Urinary Continence

NCT ID: NCT03439527

Last Updated: 2021-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-22
• Study Completion Date: 2021-10-21

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.

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

Keywords

Muscle Precursor Cells

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MPC-group

All patients are treated by the same product: Autologous MPCs

Group Type: EXPERIMENTAL

Muscle Precursor Cells (MPCs), ATMP

Intervention Type: 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.

NMES+MPC-group

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)

Group Type: OTHER

Muscle Precursor Cells (MPCs), ATMP

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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).
• Post void residual volume of <100 ml (exclusion of overflow incontinence)
• 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

Exclusion Criteria

• 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
• Fever (as defined by ≥ 38,5°C, axillar measurement), any infectious disease, cold or flu within the last 7 days
• Unstable severe systemic disease including uncontrolled hypertension, unstable angina, or myocardial infarction, severe coagulation disorders, bleeding diathesis, emboli, thrombophlebitis, infectious diseases, poor wound healing, and poorly controlled diabetes mellitus within 6 months before enrolment
• Any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results.
• Known allergy or intolerance of at least one of the active ingredients or excipients of the investigational products
• Known allergy or intolerance of Penicillin or Streptomycin
• Known genetically determined or acquired muscular disease.
• Known Neurological disorder (Parkinson's disease, multiple sclerosis, spina bifida, medullary traumatism).
• Medication regimen including estrogens, anti-estrogens or diuretics where dose and/or frequency has not been stable for at least the past 12 weeks or is anticipated to change during the course of the study.
• Chronic use of any of the following drugs and not stopped for at least 2 weeks prior to inclusion into the study: selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI), alpha-receptor antagonists/agonists, beta-3-receptor agonists or anticholinergic/-muscarinic drugs.
• Chronic use of any of the following drugs and not stopped for at least 6 months prior to inclusion into the study: Antidepressants or neuroleptic drugs.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: collaborator

Salzburger Landeskliniken

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Eberli, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

731377

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H2020-SC1-2016-2017

Identifier Type: -

Identifier Source: org_study_id