title: Autologous muscle derived cell therapy for stress urinary incontinence: a prospective, dose ranging study.
abstract: OBJECTIVE
  In this feasibility study we assessed the 12-month safety and potential efficacy of autologous muscle derived cells (Cook MyoSite Incorporated, Pittsburgh, Pennsylvania) as therapy for stress urinary incontinence.
  
  
  METHODS
  A total of 38 women in whom stress urinary incontinence had not improved with conservative therapy for 12 or more months underwent intrasphincter injection of low doses (1, 2, 4, 8 or 16 × 10(6)) or high doses (32, 64 or 128 × 10(6)) of autologous muscle derived cells, which were derived from biopsies of their quadriceps femoris. All patients could elect a second treatment of the same dose after 3-month followup. Assessments were made at 1, 3, 6 and 12 months after the last treatment. The primary end point was the incidence and severity of adverse events. In addition, changes in stress urinary incontinence severity were evaluated by pad test, diary of incontinence episodes and quality of life surveys.
  
  
  RESULTS
  Of the 38 patients 33 completed the study. Treatment related complications were limited to minor events such as pain/bruising at the biopsy and injection sites. Of patients who received 2 treatments of autologous muscle derived cells who were eligible for analysis, a higher percentage of those in the high dose vs the low dose group experienced a 50% or greater reduction in pad weight (88.9%, 8 of 9 vs 61.5%, 8 of 13), had a 50% or greater reduction in diary reported stress leaks (77.8%, 7 of 9 vs 53.3%, 8 of 15) and had 0 to 1 leaks during 3 days (88.9%, 8 of 9 vs 33.3%, 5 of 15) at final followup.
  
  
  CONCLUSIONS
  Injection of autologous muscle derived cells in a wide range of doses appears safe with no major treatment related adverse events reported. In addition, treatment with autologous muscle derived cells shows promise for relieving stress urinary incontinence symptoms and improving quality of life.
authors.affiliation: Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. Lesley.Carr@sunnybrook.ca
authors.forename: Lesley K
authors.initials: LK
authors.lastname: Carr
authors.forename: Magali
authors.initials: M
authors.lastname: Robert
authors.forename: Patricia L
authors.initials: PL
authors.lastname: Kultgen
authors.forename: Sender
authors.initials: S
authors.lastname: Herschorn
authors.forename: Colin
authors.initials: C
authors.lastname: Birch
authors.forename: Magnus
authors.initials: M
authors.lastname: Murphy
authors.forename: Michael B
authors.initials: MB
authors.lastname: Chancellor
mesh_terms: D000328:Adult; D000368:Aged; D017690:Cell Transplantation; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D009132:Muscles / Q000166:cytology; D011446:Prospective Studies; D014550:Urinary Incontinence, Stress / Q000601:surgery*