Clinical Trial Results:
Estudio fase III, multicéntrico, simple ciego, randomizado, controlado con placebo, para evaluar la eficacia y seguridad de células madre expandidas derivadas de tejido adiposo autólogo (eASCs) (CX-401) para el tratamiento de la fístula perianal compleja en la enfermedad perianal de Crohn. FATT II: Fistula Advanced Therapy Trial (II).
Randomized, single-blind, placebo-controlled multicenter phase III study to assess the efficacy and safety of expanded autologous adipose-derived stem cells (eASCs) (CX-401), for treatment of complex perianal fistulas in Crohn?s disease. FATT 2: Fistula Advanced Therapy Trial (II)
Summary
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EudraCT number |
2008-004286-25 |
Trial protocol |
ES NL AT DE BE CZ |
Global completion date |
28 Feb 2010
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
12 Sep 2020
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First version publication date |
12 Sep 2020
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Other versions |
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Summary report(s) |
CX-401 FATT2 - CSR Synopsis |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.