PMID- 37144409
OWN - NLM
STAT- MEDLINE
DCOM- 20231109
LR  - 20231122
IS  - 1528-1140 (Electronic)
IS  - 0003-4932 (Linking)
VI  - 278
IP  - 6
DP  - 2023 Dec 1
TI  - Safety and Efficacy of Iltamiocel Cellular Therapy for the Treatment of Fecal 
      Incontinence. Results of a Phase 1/2 Study.
PG  - 937-944
LID - 10.1097/SLA.0000000000005894 [doi]
AB  - OBJECTIVE: To examine the safety and efficacy of iltamiocel, an investigational 
      cellular therapy of autologous muscle-derived cells, as a treatment for fecal 
      incontinence (FI) in adults. BACKGROUND: Limited therapeutic options are 
      available for patients with FI refractory to conservative treatments. Cell 
      therapy using autologous muscle-derived cells represents a promising, minimally 
      invasive approach for restoring anal sphincter function. METHODS: In this 
      multicenter, prospective, non-randomized study, 48 participants were treated with 
      a single iltamiocel dose of 250x10 6 cells. The primary outcome was the incidence 
      of product or procedure-related adverse events (AEs) and serious AEs. Secondary 
      outcomes were changes in the number of FI episodes, Cleveland Clinic Incontinence 
      Score, Fecal Incontinence Quality of Life, and anorectal manometry at 3, 6, and 
      12 months compared to baseline. RESULTS: No serious AEs and only one 
      product-related AE of inflammation at the injection site were reported. At 12 
      months, there was a reduction in median FI episodes (-6.0; 95% confidence 
      interval (CI): -10.0, -1.0) and days with episodes (-4.0; 95% CI: -8.0, -1.0). A 
      >/=50% reduction in FI episodes was observed in 53.7% of participants, and 24.4% 
      had complete restoration of continence. Symptom severity and quality of life 
      improved with mean Cleveland Clinic Incontinence Score reduction (-2.9; 95% CI: 
      -3.7, -2.1), and Fecal Incontinence Quality of Life increased (2.2; 95% CI:1.4, 
      2.9). No significant changes were detected in anorectal manometry measurements. A 
      history of episiotomy was significantly associated with treatment response in 
      multivariate analysis. CONCLUSION: The administration of iltamiocel cellular 
      therapy is safe. Iltamiocel shows promise for significantly improving fecal 
      incontinence symptoms and quality of life.
CI  - Copyright (c) 2023 Wolters Kluwer Health, Inc. All rights reserved.
FAU - Knowles, Charles H
AU  - Knowles CH
AD  - Barts & the London School of Medicine & Dentistry, Queen Mary University of 
      London, London, UK.
FAU - Canestrari, Emanuele
AU  - Canestrari E
AD  - Cook MyoSite, Pittsburgh, PA, USA.
FAU - Jankowski, Ron J
AU  - Jankowski RJ
AD  - Cook MyoSite, Pittsburgh, PA, USA.
FAU - Cardello, Kelly
AU  - Cardello K
AD  - Cook MyoSite, Pittsburgh, PA, USA.
FAU - Raval, Manoj J
AU  - Raval MJ
AD  - St. Paul's Hospital, University of British Columbia, Vancouver, BC, Canada.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
DEP - 20230505
PL  - United States
TA  - Ann Surg
JT  - Annals of surgery
JID - 0372354
SB  - IM
MH  - Adult
MH  - Female
MH  - Humans
MH  - *Fecal Incontinence/therapy
MH  - Treatment Outcome
MH  - Prospective Studies
MH  - Quality of Life
MH  - Anal Canal/surgery
MH  - Manometry
EDAT- 2023/05/05 06:42
MHDA- 2023/11/09 06:42
CRDT- 2023/05/05 05:27
PHST- 2023/11/09 06:42 [medline]
PHST- 2023/05/05 06:42 [pubmed]
PHST- 2023/05/05 05:27 [entrez]
AID - 00000658-202312000-00016 [pii]
AID - 10.1097/SLA.0000000000005894 [doi]
PST - ppublish
SO  - Ann Surg. 2023 Dec 1;278(6):937-944. doi: 10.1097/SLA.0000000000005894. Epub 2023 
      May 5.