Early Results of a Phase I Trial Using an Adipose-Derived Mesenchymal Stem Cell-Coated Fistula Plug for the Treatment of Transsphincteric Cryptoglandular Fistulas.
Journal
Diseases of the colon and rectum
ISSN: 1530-0358
Titre abrégé: Dis Colon Rectum
Pays: United States
ID NLM: 0372764
Informations de publication
Date de publication:
05 2019
05 2019
Historique:
pubmed:
22
1
2019
medline:
21
5
2019
entrez:
22
1
2019
Statut:
ppublish
Résumé
Management of transsphincteric cryptoglandular fistulas remains a challenging problem and the optimal surgical approach remains elusive. Mesenchymal stem cells, increasingly being utilized for perianal Crohn's disease, offer a novel therapy to treat cryptoglandular fistulas. This study aimed to determine safety and feasibility of using an autologous mesenchymal stem cell-coated fistula plug in patients with transsphincteric cryptoglandular fistulas. This study is a phase I clinical trial. This study was conducted at a tertiary academic medical center. Adult (>18 years) male and female patients with transsphincteric cryptoglandular fistulas were selected. The primary outcomes measured were the safety, feasibility, and efficacy of a mesenchymal stem cell-coated fistula plug in patients with transsphincteric fistulas. Fifteen patients (8 women, mean age 39.8 years) with a single-tract transsphincteric fistula received a mesenchymal stem cell-loaded fistula plug and were followed for 6 months. Duration of disease at the time of study enrollment was a median of 3.0 years (range, 1-13 years) with a median of 3.5 (range, 1-20) prior surgical interventions. Adverse events included 1 plug extrusion, 1 abdominal wall seroma, 3 perianal abscesses requiring drainage, and 1 patient with perianal cellulitis. There were no serious adverse events. At 6 months, 3 patients had complete clinical healing, 8 had partial healing, and 4 patients showed no clinical improvement. Radiographic improvement was seen in 11 of 15 patients. This study was limited by the small cohort and short follow-up. Autologous mesenchymal stem cell-coated fistula plug treatment of transsphincteric cryptoglandular fistulas was safe and feasible and resulted in complete or partial healing in a majority of patients. See Video Abstract at http://links.lww.com/DCR/A897.
Sections du résumé
BACKGROUND
Management of transsphincteric cryptoglandular fistulas remains a challenging problem and the optimal surgical approach remains elusive. Mesenchymal stem cells, increasingly being utilized for perianal Crohn's disease, offer a novel therapy to treat cryptoglandular fistulas.
OBJECTIVES
This study aimed to determine safety and feasibility of using an autologous mesenchymal stem cell-coated fistula plug in patients with transsphincteric cryptoglandular fistulas.
DESIGN
This study is a phase I clinical trial.
SETTING
This study was conducted at a tertiary academic medical center.
PATIENTS
Adult (>18 years) male and female patients with transsphincteric cryptoglandular fistulas were selected.
MAIN OUTCOMES MEASURES
The primary outcomes measured were the safety, feasibility, and efficacy of a mesenchymal stem cell-coated fistula plug in patients with transsphincteric fistulas.
RESULTS
Fifteen patients (8 women, mean age 39.8 years) with a single-tract transsphincteric fistula received a mesenchymal stem cell-loaded fistula plug and were followed for 6 months. Duration of disease at the time of study enrollment was a median of 3.0 years (range, 1-13 years) with a median of 3.5 (range, 1-20) prior surgical interventions. Adverse events included 1 plug extrusion, 1 abdominal wall seroma, 3 perianal abscesses requiring drainage, and 1 patient with perianal cellulitis. There were no serious adverse events. At 6 months, 3 patients had complete clinical healing, 8 had partial healing, and 4 patients showed no clinical improvement. Radiographic improvement was seen in 11 of 15 patients.
LIMITATIONS
This study was limited by the small cohort and short follow-up.
CONCLUSIONS
Autologous mesenchymal stem cell-coated fistula plug treatment of transsphincteric cryptoglandular fistulas was safe and feasible and resulted in complete or partial healing in a majority of patients. See Video Abstract at http://links.lww.com/DCR/A897.
Identifiants
pubmed: 30664554
doi: 10.1097/DCR.0000000000001333
doi:
Types de publication
Clinical Trial, Phase I
Journal Article
Video-Audio Media
Langues
eng
Sous-ensembles de citation
IM