Fistulae

Stem cells from fat are being investigated as possible treatments for fistulae. Click on the link provided to find out more about each trial. It remains too early to know which approach will be most suitable. We need evidence collected in clinical trials to determine if a proposed stem cell treatment is both safe and effective.

tagged as Fistulae

  • Stem Cells Treatment for Extremely Complex Fistulae Location: Spain
    Overview: This trial is being undertaken by the Instituto de Investigación Hospital Universitario in La Paz to determine whether the patient’s own stem cells can assist healing in complex perianal fistulae. Stem cells will be harvested from fat and will be implanted into the walls of the perianal fistula. Healing will be monitored by ultrasound up to six months after treatment. Participants will also be assessed for complications. The trial expects to recruit 10 subjects between March 2012 and December 2013.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Adult Fatty Tissue Stem Cells
  • Autologous Cell Therapy for Treatment of Fecal Incontinence Location: Canada
    Overview: This trial is investigating the potential of the patient’s muscle cells for the treatment of anal sphincter incontinence. The trial is being conducted at St Pauls Hospital Vancouver and The Jewish General Hospital Montréal and is sponsored by Cook Myosite a biotech pharmaceutical company. The patient’s muscle progenitor cells will be injected directly into the anal sphincter. The trial expects to enrol 30 participants by December 2014 and to conclude by December 2015. Participants will be monitored for complications and anal sphincter functions such as incontinence episodes, incontinence score and sphincter pressure.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Stem Cells (unspecified)
  • Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn's disease Location: Spain
    Overview: This trial aims to assess the safety and effectiveness of using stem cells derived from donated fat for the treatment of perianal fistulas in patients with Crohn's disease. The trial is being sponsored by CELLERIX, S.A and will be conducted at several sites in Europe. The trial proposes to recruit around 200 subjects who have Crohn's disease with complex perianal fistulas. Participants will be randomly allocated into an experimental group which will receive an injection of a proprietary fat derived and expanded stem cells directly into the fistula, or into the control group that will receive a placebo injection only. Participants will be monitored for complications and for fistula healing. The trial commenced in June 2012 and is expected to be completed by 2015.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Adult Fatty Tissue Stem Cells
  • Stromal Vascular Fraction for Treatment of Recto-vaginal Fistula Location: Spain
    Overview: This trial aims to investigate the effects of cells obtained from liposuction for repair of recto-vaginal fistula. The trial is being conducted at the Instituto de Investigación Hospital Universitario La Paz in Madrid and plans to recruit 10 subjects with recto-vaginal fistula. All subjects will receive an injection of fat derived vascular stromal fraction cells directly into the fistula. Participants will be monitored for complications and for fistula healing. The trial is expected to be completed in late 2013.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Adult Fatty Tissue Stem Cells
  • Stromal Vascular Fraction for Treatment of Enterocutaneous Fistula Location: Spain
    Overview: This trial is investigating the effects of cells from cells obtained from liposuction for repair of entero-cutaneous fistula. The trial is being conducted at the Instituto de Investigación Hospital Universitario La Paz in Spain plans to recruit 10 subjects with entero-cutaneous fistula. All subjects will receive an injection of fat derived vascular stromal fraction cells directly into the fistula. Participants will be monitored for complications and for fistula healing. The trial is expected to be completed in late 2013.
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Adult Fatty Tissue Stem Cells