Hemotrial Un proyecto de SEHH

Ensayo clínico

"A Phase III multicenter, single blind, randomized, comparative, add?on clinical trial, in three parallel groups, to evaluate the efficacy and safety of a new therapy with adipose?derived autologous stem cells for the treatment of complex perianal fistulas in patients without inflammatory bowel disease" FATT I: Fistula Advanced Therapy Trial (I) Ensayo clínico fase III multicéntrico, simple ciego, aleatorizado, comparativo, add on, en tres grupos paralelos para evaluar la eficacia y seguridad de una nueva terapia con células madre autólogas derivadas de lipoaspirado, para el tratamiento de las fístulas perianales complejas en pacientes sin enfermedad de Crohn.

  • Guardar

  • Imprimir
  • << Volver

Resumen

2017-03-15 04:00:38
2006-003370-95
Cx401/FATT1
"A Phase III multicenter, single blind, randomized, comparative, add?on clinical trial, in three parallel groups, to evaluate the efficacy and safety of a new therapy with adipose?derived autologous stem cells for the treatment of complex perianal fistulas in patients without inflammatory bowel disease" FATT I: Fistula Advanced Therapy Trial (I) Ensayo clínico fase III multicéntrico, simple ciego, aleatorizado, comparativo, add on, en tres grupos paralelos para evaluar la eficacia y seguridad de una nueva terapia con células madre autólogas derivadas de lipoaspirado, para el tratamiento de las fístulas perianales complejas en pacientes sin enfermedad de Crohn.
FATT 1
Cx401/FATT1
Name:N/ANumber:N/A

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
CELLERIX, S.L. CELLERIX, S.L. Jacobo Blanco Spain

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test TISSUCOL DUO
BAXTER LABORATORIES ASCs:adipose derived stem cells
ASCs Suspension for injection
Intralesional use

Detalles del Fármaco (Principio Activo):
ASCs autologous Suspension of a

Concentración del fármaco:
Other equal

60000000

Contenido del fármaco

No
Si

No
No

No
No

No
No

No
No

No
No

No
  FÁRMACO 2:
Comparator
TISSUCOL DUO (5.0ML) FIBRIN TISSUE ADHESIVE
Gel
Intralesional use

Detalles del Fármaco (Principio Activo):
TISSUCOL

Concentración del fármaco:
ml millilitre(s equal

5

Contenido del fármaco

Si
No

No
No

No
No

No
No

No
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:
  PLACEBO 1:

Si
Solution for injection

Intralesional use

Información General

Terapia Celular, Trasplante Hematopoyético

Treatment of complex perianal fistulas in patients without inflammatory bowel disease. Tratamiento de las fístulas perianales complejas en pacientes sin enfermedad inflamatoria intestinal.

Compare the efficacy of ASCs versus ASCs plus fibrin adhesive versus fibrin adhesive for closure of complex perianal fistulas not associated to inflammatory bowel disease. Fistula closure is defined as absence of suppuration of the fistula through the external orifice, spontaneously and by pressure, and complete re-epithelization of the external orifice in the clinical evaluation and absence of collections >2 cm. directly related to the fistula tract treated, as measured by MRI

1. Evaluate the changes over time in the clinical complexity of the fistula in patients treated with ASCs, ASCs plus fibrin adhesive, and fibrin adhesive alone.2. Compare the efficacy of ASCs vs ASCs plus fibrin adhesive and fibrin adhesive alone, for clinical evaluated closure of complex perianal fistulas not associated to inflammatory bowel disease. 3.Evaluate the safety in patients treated with ASCs vs ASCs plus fibrin adhesive versus fibrin adhesive alone. 4.Evaluate the quality of life of patients treated with ASCs in comparison to those treated wit ASCs plus fibrin adhesive and with fibrin adhesive alone (SF36 score). 5. Evaluate the degree of fecal incontinence (if any) using Wexner clinical scale (Wexner incontinence score) in patients treated with ASCs in comparison to those treated wit ASCs plus fibrin adhesive and with fibrin adhesive alone 6.Evaluate the number of surgeries avoided in patients treated with ASCs compared to those treated with fibrin adhesive alone

No


a.Patient with a complex perianal fistula amenable to local treatment with ASCs, as judged by the investigator after a clinical examination and MRI have been conducted. b.Patient of any sex aged 18 years or olderc.Women of childbearing age should have a negative serum or urine pregnancy test and not be lactating before study entry. Both men and women should use adequate birth control methods as defined by the investigator.d.Seton presence is allowed at the time of study entry and until cells (in groups receiving ASCs) or fibrin adhesive are implanted.e.No condition that may prevent the patient from following the study procedures until 26 weeks of follow?up are completed is foreseen.f.Patient should give his/her signed, written informed consent.

a.Patient has been diagnosed with inflammatory bowel disease, as documented by radiology/endoscopy/histopathology.b.Patient has a rectovaginal fistula.c.Patient is a pregnant or lactating womand.Patient has acute sepsis at the time of study entrye.A liposuction to draw al least 100 cc3 of fat from the abdominal wall is not technically feasible, or does not want this procedure to be performed. f.Patient needs surgery in the perianal region for reasons other than fistulas at the time of study entry, or is expected to possibly need any type of surgery in that area in the next 26 weeks. Abscess drainage is permitted. g.Presence of two or more complex perianal fistulas.h.Patient has collections >2 cm in MRI. If such collections exist, the patient may participate in the study if the investigating surgeon performs a complete toilette of the area, draining collections, and the absence of such collections or other collections >2 cm is shown in a subsequent MRI. i.Patient is allergic to local anesthetics or Gadolinium (MRI contrast agent)

Proportion or patients in whom the external openings of the treated perianal fistula are closed clinically evaluated (absence of suppuration through the external opening of the fistula, spontaneously and by pressure, and the complete re-epithelization of the external opening) and also by MRI (absence of collections >2cm associated to the fistulous tract) after the ASC treatment cycle (1 + 1) with a dose of approximately 20 million ASCs in the first administration and 40 millions in the second administration, compared to the proportion of patients treated with ASCs plus fibrin adhesive or with fibrin adhesive alone, 24 weeks after receiving the first dose of study medication (26 in patients with a second dose.)

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

No
Si

No
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
Si

No
No

Si

Centros participantes:

Si
Information no disponible en EudraCT
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO:

1
6
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO EN ESPAÑA:


  POBLACIÓN DE PACIENTES EN EL ESTUDIO:
  Población de pacientes: 1

Rango de edad:

0
1

1

Sexo:

1
1

Número planeado de pacientes a incluir:

0

Para estudios internacionales:

207
207

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


 Por Determinar



En Marcha