Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's Disease
This trial is active, not recruiting.
|Treatments||cx601, saline solution|
|Start date||July 2012|
|End date||July 2015|
|Trial size||278 participants|
|Trial identifier||NCT01541579, Cx601-0302|
The current multicentre phase III study is proposed to confirm in an add-on therapy design compared to a placebo-control group, the efficacy of adipose-derived stem cells (eASCs) from healthy donors for the treatment of complex anal fistulas in patients with Crohn's disease over a 24-week period and an extended follow-up period up to 104 weeks.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Innsbruck, Austria||Univ.-Klinik Innsbruck||no longer recruiting|
|St. Veit/Glan, Austria||Krankenhaus||no longer recruiting|
|Wien, Austria||Medizinische Universität||no longer recruiting|
|Genk, Belgium||Hospital Oost-Limburg||no longer recruiting|
|Gent, Belgium||Gent University Hospital||no longer recruiting|
|Leuven, Belgium||Leuven University Hospital||no longer recruiting|
|Roeselare, Belgium||Hospital Hartziekenhuis||no longer recruiting|
|Amiens, France||CHU d'Amiens||no longer recruiting|
|Bordeaux, France||CHU de Bordeaux||no longer recruiting|
|Caen, France||CHU de Caen||no longer recruiting|
|Clichy, France||Hôpital Beaujon||no longer recruiting|
|Lille, France||CHRU de Lille||no longer recruiting|
|Marseille, France||CHU de Marseille||no longer recruiting|
|Nice, France||CHU de Nice||no longer recruiting|
|Paris, France||Hôpital Saint-Louis||no longer recruiting|
|Berlin, Germany||Charite||no longer recruiting|
|Berlin, Germany||Krakenhaus Walfriede||no longer recruiting|
|Braunschweig, Germany||Klinikum Braunscheweig||no longer recruiting|
|Frankfurt/Main, Germany||Klinikum Frankfurt||no longer recruiting|
|Köln, Germany||Evangelisches Krankenhaus Kalk||no longer recruiting|
|Lüneburg, Germany||Klinikum Lüneburg||no longer recruiting|
|Haifa, Israel||Rambam MC||no longer recruiting|
|Jerusalem, Israel||Sharee Zedek MC||no longer recruiting|
|Petah Tikva, Israel||Rabin MC||no longer recruiting|
|Tel Aviv, Israel||Tel Aviv Sourasky MC||no longer recruiting|
|Tel Hashomer, Israel||Sheba MC||no longer recruiting|
|Bologna, Italy||Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant'Orsola Malpighi||no longer recruiting|
|Firenze, Italy||Azienda Ospedaliero-Universitaria Careggi||no longer recruiting|
|Milano, Italy||Instituto Clinico Humanitas IRCCS||no longer recruiting|
|Napoli, Italy||Seconda Università degli Studi di Napoli||no longer recruiting|
|Padova, Italy||Azienda Ospedaliera di Padova||no longer recruiting|
|Rome, Italy||Azienda Ospedaliera San Camillo-Forlanini||no longer recruiting|
|Rome, Italy||Università Cattolica del Sacro Cuore||no longer recruiting|
|Amsterdam, Netherlands||AMC||no longer recruiting|
|Amsterdam, Netherlands||VUMC||no longer recruiting|
|Eindhoven, Netherlands||Catharina Ziekenhuis||no longer recruiting|
|Utrecht, Netherlands||UMCU||no longer recruiting|
|Manises, Spain||Hospital de Manises||no longer recruiting|
|Barcelona, Spain||Hospital Clinic de Barcelona||no longer recruiting|
|Cordoba, Spain||Hospital Universitario Reina Sofia||no longer recruiting|
|Huelva, Spain||Hospital Juan Ramon Jimenez||no longer recruiting|
|Madrid, Spain||Hospital Ramón y Cajal||no longer recruiting|
|Madrid, Spain||Fundacion Jimenez Diaz||no longer recruiting|
|Madrid, Spain||Hospital 12 de Octubre||no longer recruiting|
|Madrid, Spain||Hospital Clinico San Carlos||no longer recruiting|
|Madrid, Spain||Hospital La Princesa||no longer recruiting|
|Madrid, Spain||Hospital Universitario La Paz||no longer recruiting|
|Palma de Mallorca, Spain||Son Espases||no longer recruiting|
|Pontevedra, Spain||Hospital de Montecelo||no longer recruiting|
|Seville, Spain||Hospital Virgen del Rocio||no longer recruiting|
|Valencia, Spain||Hospital de Sagunto||no longer recruiting|
|Valencia, Spain||Hospital Universitario La Fe||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Combine remission of perianal fistulising Crohn's
time frame: 24 weeks
Efficacy Assessment by week 24
time frame: 24 weeks
Efficacy Assessment by week 52
time frame: 52 weeks
Efficacy Assessment by week 104
time frame: 104 Weeks
Safety analysis throughout the study:
time frame: week 24, 52 and 104
Male or female participants at least 18 years old.
- Signed informed consent.
- Patients with Crohn's Disease (CD) diagnosed at least 6 months earlier in accordance with accepted clinical, endoscopic, histological and/or radiologic criteria.
- Presence of complex perianal fistulas with a maximum of 2 fistulas (internal openings) and a maximum of 3 external openings, assessed by clinical assessment and MRI. Fistula must have been draining for at least 6 weeks prior to the inclusion. A complex perianal fistula is defined as a fistula that met one or more of the following criteria during its evolution:
- High inter-sphincteric, trans-sphincteric, extra-sphincteric or supra-sphincteric.
- Presence of ≥ 2 external openings (tracts).
- Associated collections
- Non-active or mildly active luminal CD defined by a CDAI ≤ 220.
- Patients of either sex aged 18 years or older
- Good general state of health according to clinical history and a physical examination.
- For women of a childbearing age, they must have negative serum or urine pregnancy test (sensitive to 25 IU human chorionic gonadotropin (hCG)). Both men and women should use appropriate birth control methods defined by the investigator.
- Presence of dominant luminal active Crohn's disease requiring immediate therapy.
- CDAI >220.
- Concomitant rectovaginal fistulas
- Patient naïve to specific treatment for perianal fistulising Crohn's disease including antibiotics
- Presence of an abscess or collections > 2 cm, unless resolved in the preparation procedure (week -3 to day 0).
- Presence of > 2 fistular lesions.
- Presence of > 3 external openings.
- Rectal and/or anal stenosis and / or active proctitis, if this means a limitation for any surgical procedure.
- Patient who underwent surgery for the fistula other than drainage or seton placement.
- Patient with diverting stomas
- Patient with ongoing steroid treatment or treated with steroids in the last 4 weeks
- Renal impairment defined by creatinine clearance below 60 ml/min calculated using Cockcroft-Gault formula or by serum creatinine ≥ 1.5 x upper limit of normality (ULN)
- Hepatic impairment defined by both of the following laboratory ranges:
- Total bilirubin ≥ 1.5 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase(ALT) ≥ 2.5 x ULN
- Known history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion.
- Malignant tumour or patients with a prior history of any malignant tumour, including any type of fistula carcinoma.
- Current or recent history of abnormal, severe, progressive, uncontrolled hepatic, haematological, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral disease.
- Congenital or acquired immunodeficiencies.
- Known allergies or hypersensitivity to antibiotics including but not limited to penicillin, streptomycin, gentamicin, aminoglycosides; Human Serum Albumin (HSA); Dulbecco Modified Eagle's Medium (DMEM); materials of bovine origin; local anaesthetics or gadolinium (MRI contrast).
- Contraindication to MRI scan, (e.g., due to the presence of pacemakers, hip replacements or severe claustrophobia).
- Major surgery or severe trauma within the previous 6 months.
- Pregnant or breastfeeding women.
- Patients who do not wish to or cannot comply with study procedures.
- Patients currently receiving, or having received within 3 months prior to enrolment into this clinical study, any investigational drug.
- Patients previously treated with eASCs can not be enrol into this clinical study.
- Subjects who need surgery in the perianal region for reasons other than fistulas at the time of inclusion in the study, or for whom such surgery is foreseen in this region in the 24 weeks after treatment administration.
- Contraindication to the anaesthetic procedure.
|Official title||A Phase III, Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicentre Study to Assess Efficacy and Safety of Expanded Allogeneic Adipose-derived Stem Cells (eASCs) for the Treatment of Perianal Fistulising Crohn's Disease Over a Period of 24 Weeks and an Extended Follow-up Period up to 104 Weeks.|
|Principal investigator||Julian Panes, MD|
|Description||The current multicentre phase III study is proposed to confirm in an add-on therapy design compared to a placebo-control group, the efficacy of adipose-derived stem cells (eASCs) from healthy donors for the treatment of complex anal fistulas in patients with Crohn's disease over a 24-week period and an extended follow-up period up to 104 weeks. Subject with perianal fistulising Crohn's disease will be treated with Cx601, suspension of eASCs, at a dose of 120 million cells administered by intralesional injection. The treatment of complex perianal fistulas by local application of eASCs intends to improve significantly the local conditions with very few inconveniences (ambulatory procedure) and minimal risk of possible complications (anal incontinence). Therefore, this is a new therapeutic resource that is expected to be safe and efficacious as well as is expected to improve the quality of life of the patients in this highly debilitating and chronic condition. This treatment would prevent one of the main causes of anal incontinence, would diminish recurrence of the fistula disease and would reduce drastically the significant disorders provoked by the standard fistula surgery in the patients. Indeed, patients can be discharged according to the "One Day Surgical" procedures (major ambulatory surgery).|
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