Document Detail


Autologous expanded adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistulas: a phase III randomized clinical trial (FATT 1: fistula Advanced Therapy Trial 1) and long-term evaluation.
MedLine Citation:
PMID:  22706128     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Autologous adipose-derived stem cells may represent a novel approach for the management of complex fistula-in-ano. After successful phase I and II clinical trials, a phase III trial was performed to investigate the safety and efficacy.
DESIGN: In this multicenter, randomized, single-blind, add-on clinical trial, 200 adult patients from 19 centers were randomly assigned to receive 20 million stem cells (group A, 64 patients), 20 million adipose-derived stem cells plus fibrin glue (group B, 60 patients), or fibrin glue (group C, 59 patients) after closure of the internal opening. Fistula healing was defined as reepithelization of the external opening and absence of collection >2 cm by MRI. If the fistula had not healed at 12 weeks, a second dose (40 million stem cells in groups A and B) was administered. Patients were evaluated at 24 to 26 weeks (primary end point) and at 1 year (long-term follow-up).
RESULTS: All results are according to the "blinded evaluator" assessment. After 24 to 26 weeks, the healing rate was 39.1%, 43.3%, 37.3% in groups A, B, and C (p = 0.79). At 1 year, the healing rates were 57.1%, 52.4%, and 37.3 % (p = 0.13). On analysis of the subpopulation treated at the technique's pioneer center, healing rates were 54.55%, 83.33%, and 18.18%, at 24 to 26 weeks (p < 0.001). No SAEs were reported.
CONCLUSIONS: In treatment of complex fistula-in-ano, a dose of 20 or 60 million adipose-derived stem cells alone or in combination with fibrin glue was considered a safe treatment, achieving healing rates of approximately 40% at 6 months and of more than 50% at 1-year follow-up. It was equivalent to fibrin glue alone. No statistically significant differences were found when the 3 groups where compared.
CLINICAL TRIALS REGISTRATION: www.clinicaltrials.gov, identifier NCT00475410; Sponsor, Cellerix SA.
Authors:
M D Herreros; M Garcia-Arranz; H Guadalajara; P De-La-Quintana; D Garcia-Olmo;
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Diseases of the colon and rectum     Volume:  55     ISSN:  1530-0358     ISO Abbreviation:  Dis. Colon Rectum     Publication Date:  2012 Jul 
Date Detail:
Created Date:  2012-06-18     Completed Date:  2012-08-28     Revised Date:  2014-07-31    
Medline Journal Info:
Nlm Unique ID:  0372764     Medline TA:  Dis Colon Rectum     Country:  United States    
Other Details:
Languages:  eng     Pagination:  762-72     Citation Subset:  IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00475410;  NCT01020825
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MeSH Terms
Descriptor/Qualifier:
Adipocytes / cytology*
Adult
Combined Modality Therapy
Female
Fibrin Tissue Adhesive / administration & dosage*,  adverse effects
Follow-Up Studies
Humans
Male
Mesenchymal Stem Cell Transplantation*
Middle Aged
Rectal Fistula / therapy*
Single-Blind Method
Spain
Tissue Adhesives / administration & dosage*,  adverse effects
Transplantation, Autologous
Treatment Outcome
Chemical
Reg. No./Substance:
0/Fibrin Tissue Adhesive; 0/Tissue Adhesives
Investigator
Investigator/Affiliation:
M D Herreros / ; H Guadalajara / ; P De-La-Quintana / ; I Pascual / ; J Trebol / ; T Georgiev-Hristov / ; C Gonzalez-Gomez / ; M Garcia-Arranz / ; E Del-Valle / ; J Zorrilla / ; M Rodriguez / ; L M Jiménez / ; F Muñoz / ; J A Pascual Montero / ; T Butron Vila / ; M Lomas Espadas / ; J Cerdán / ; M García / ; F Jiménez / ; J A Alvarez Sánchez / ; M P Hernández / ; J Garcia-Armengol / ; J V Roig / ; F L Villalba / ; J A Pando / ; A Navarro / ; C Maristany / ; A Muñoz-Duyos / ; J Camps / ; J M Ramirez / ; V Aguilella / ; M A Bielsa / ; M Martínez / ; J Baixauli / ; J L Hernández-Lizoain / ; C Pastor / ; B Oronoz / ; F X González Argenté / ; J J Espert / ; J M Enríquez-Navascués / ; C Placer / ; M Gómez Fleitas / ; J del Castillo / ; A Codina Cazador / ; R Farres Coll / ; J Garcia Garcia / ; J A Alcazar Montero / ; L M Gonzalez Fernandez / ; M D Ruiz Carmona / ; A Solana Bueno / ; R Alós Company / ; V Pla Martí / ; D Moro Valdezate / ; A Galindo Galindo / ; J M Lorente Herce / ; M Marquez Muñoz / ; O Mulet Zayas / ; V Vicente Guillén / ; C Olona Casas / ; A Caro Tarragó / ; J Serra Aracil / ; J Bombardó / ; M de Miguel / ; H Ortiz /

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