PMID- 23053677
OWN - NLM
STAT- MEDLINE
DCOM- 20130814
LR  - 20220410
IS  - 1432-1262 (Electronic)
IS  - 0179-1958 (Linking)
VI  - 28
IP  - 3
DP  - 2013 Mar
TI  - Expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of 
      complex perianal fistula in Crohn's disease: results from a multicenter phase 
      I/IIa clinical trial.
PG  - 313-23
LID - 10.1007/s00384-012-1581-9 [doi]
AB  - PURPOSE: The management of perianal fistula in patients with Crohn's disease is 
      an extremely challenging medical problem as many fistulas do not respond to 
      available treatments. The objectives were to assess the safety and efficacy of a 
      suspension of expanded adipose-derived allogeneic mesenchymal stem cells (eASCs) 
      for the treatment of complex perianal fistula in Crohn's disease METHODS: An 
      open-label, single-arm clinical trial was conducted at six Spanish hospitals. 
      Twenty-four patients were administered intralesionally with 20 million eASCs in 
      one draining fistula tract. A subsequent administration of 40 million eASCs was 
      performed if fistula closure was incomplete at week 12. Subjects were followed 
      until week 24 after the initial administration. RESULTS: Treatment-related 
      adverse events did not indicate any clinical safety concerns after 6 months 
      follow-up. The full analysis of efficacy data at week 24 showed 69.2 % of the 
      patients with a reduction in the number of draining fistulas, 56.3 % of the 
      patients achieved complete closure of the treated fistula achieved, and 30 % of 
      the cases presenting complete closure of all existing fistula tracts. Of note, 
      closure was strictly defined as: absence of suppuration through the external 
      orifice and complete re-epithelization, plus absence of collections measured by 
      magnetic resonance image scan (MRI). Furthermore, MRI Score of Severity showed 
      statistically significant differences at week 12 with a marked reduction at week 
      24. CONCLUSIONS: Locally injected eASCs appear to be a simple, safe, and 
      beneficial therapy for perianal fistula in Crohn's disease patients. Additional 
      studies are needed to further confirm the efficacy of the eASCs.
FAU - de la Portilla, F
AU  - de la Portilla F
AD  - Coloproctology Unit, Gastrointestinal Surgery Department, Virgen del Rocio 
      University Hospital, Avda. Manuel Siurot s/n, 41013 Seville, Spain. 
      delaportilla@ya.com
FAU - Alba, F
AU  - Alba F
FAU - Garcia-Olmo, D
AU  - Garcia-Olmo D
FAU - Herrerias, J M
AU  - Herrerias JM
FAU - Gonzalez, F X
AU  - Gonzalez FX
FAU - Galindo, A
AU  - Galindo A
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20120929
PL  - Germany
TA  - Int J Colorectal Dis
JT  - International journal of colorectal disease
JID - 8607899
SB  - IM
MH  - Adipose Tissue/*cytology
MH  - Adult
MH  - Cell Proliferation
MH  - Crohn Disease/*complications
MH  - Demography
MH  - Female
MH  - Humans
MH  - Male
MH  - Rectal Fistula/*etiology/*therapy
MH  - *Stem Cell Transplantation/adverse effects
MH  - Stem Cells/*cytology
MH  - Time Factors
MH  - Transplantation, Homologous/adverse effects
MH  - Treatment Outcome
EDAT- 2012/10/12 06:00
MHDA- 2013/08/15 06:00
CRDT- 2012/10/12 06:00
PHST- 2012/09/16 00:00 [accepted]
PHST- 2012/10/12 06:00 [entrez]
PHST- 2012/10/12 06:00 [pubmed]
PHST- 2013/08/15 06:00 [medline]
AID - 10.1007/s00384-012-1581-9 [doi]
PST - ppublish
SO  - Int J Colorectal Dis. 2013 Mar;28(3):313-23. doi: 10.1007/s00384-012-1581-9. Epub 
      2012 Sep 29.