Transurethral Myoblast Injection for Urinary Incontinence in Children With Bladder Exstrophy

Summary

Muscle precursor cells constantly regenerate striated muscles, and include the quiescent satellite cells located beneath the basal lamina of skeletal myofibers, which are responsible for repair of the terminally differentiated striated muscle tissue. Transurethral implantation of autologous myoblasts may represent an improved alternative to synthetic bulking agents, with the unique ability to compensate for the deficient muscle fibers in the urethral sphincter. Clinical studies of cell therapy based treatment of sphincter insufficiency, using muscle derived stem cell transplantation was carried out in patients with stress incontinence revealed and confirmed the ability of cell therapy to improve the structure and contractile function of the sphincter. In this study autologous heterotopic myoblasts will be transurethrally injected in patients with bladder extrophy epispadias complex who remained incontinent after staged bladder reconstruction and bladder neck reconstruction.

The aim of this study is to investigate the potential therapeutic effects of autologous myoblast injection for the treatment of children presenting with urinary incontinence after modern staged repair and bladder neck reconstruction of extrophy-epispadias complex as well as studying the safety, efficacy and durability of the procedure, and health related quality of life.

Conditions

• Urinary Incontinence

Interventions

PROCEDURE

Myoblast Transplantation

For each patient 4-7 Million cells per ml will be injected into 8 to 10 sites through a cystoscopic injection needle with a 10 mm long, 21 gauge needle connected to a 30 cm long plastic tube, using a 6.75Fr neonatal cystourethroscope. The suspension will be injected in the area of the external sphincter and along the posterior urethra proximal to the verumontanum, aiming to attain visual occlusion of the urethral lumen.

BIOLOGICAL

Neonatal Cystourethroscope Injection

4-7 Million cells per ml will be injected into 8 to 10 sites through a cystoscopic injection needle with a 10 mm long, 21 gauge needle connected to a 30 cm long plastic tube, using a 6.75Fr neonatal cystourethroscope.

Sponsors & Collaborators

• Cairo University

  collaborator OTHER

• Affiliated Hospital to Academy of Military Medical Sciences

  collaborator OTHER

• Al-Azhar University

  lead OTHER

Principal Investigators

• Abdel-Wahab El-Okby, MD · Deaprtment of Pediatric Surgery School of Medicine Al Azhar University

• Abd-Elmoneim Shawky Shams El-deen, MD · Department of Pediatric Surgery , School of Medicine, Al Azhar University

• Hussein Galal, MD · Department of Urology, School of Medicine, Al Azhar University

• Sayed Bakry, PhD · Laboratory of Molecular Biology , School of Science, Al Azhar University

• Hala Gabr, MD · Department of Clinical Pathology , School of Medicine, Al Azhar University

• Wael Abu El Khier, MD · Department of Clinical Pathology and Immunology, Military Academy

• Ahmed Said Sayed Bayomy, MSc · Department of Pediatric Surgery, School of Medicine, Al Azhar University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

2 Years

Max Age

10 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-12-31

Primary Completion

2015-11-30

Completion

2016-12-31

Countries

• Egypt

Study Locations