Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter Phase I/IIa Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.|
- Incidence of treatment emergent adverse-events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- The reduction in the number of draining fistulas [ Time Frame: weeks 10,12, 22 and 24 ] [ Designated as safety issue: No ]
- The increase in the number of closed fistulas. [ Time Frame: weeks 12 and 24 ] [ Designated as safety issue: No ]
- Percentage of subjects in whom, the external openings of treated perianal fistula have closed. [ Time Frame: week 12 ] [ Designated as safety issue: No ]
- Percentage of subjects with MRI fistula healing (absence of collections >2cm) [ Time Frame: weeks 12 and 24 ] [ Designated as safety issue: No ]
- Percentage of subjects presenting luminal relapse [ Time Frame: weeks 12 and 24. ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Suspension of adult expanded allogenic adipose-derived stem cells (eASCs) at a doses of 20 million cells and 40 million cells.
Crohn´s disease (CD) is a severe disorder with significant morbidity and major impact on life. CD can affect any part of the digestive system and symptoms of this chronic illness include abdominal pain, bloating, nausea, vomiting and diarrhea. CD also causes bowel wall ulcers, strictures (narrowing of a hollow structure due to scar tissue and swelling), and fistulas (abnormal passages from the intestines to another organ or the skin).
There is an unmet need for effective medical therapy in CD patients with perianal fistulas, not responding to the conventional strategies, including biological therapies. The current study is designed to assess the safety and efficacy of adipose tissue derived mesenchymal stem cells from healthy donors for the treatment of perianal fistulas in patients presenting CD.
Primary objective: To assess the safety (incidence of treatment emergent adverse-events) of eASCs.
Study design: Multicenter, pilot study, assessing safety and with evaluation of the efficacy by two Gastroenterologists/Surgeons and an independent external radiologist. Subjects will receive a cell suspension of allogenic adipose-derived stem cells, eASCs (20 million cells) in the fistula.
In case of incomplete fistula closure of the treated fistula at week 12, subjects will receive a second dose of eASCs (40 million cells). Subjects will be followed until week 24, following the initial administration of cells.
Subjects may be treated with standard care during the entire study period, according to the investigators discretion, excluding infliximab or any other anti-TNF, tacrolimus or cyclosporine.
. Study population: In total 24 patients, men and women of at least 18 years of age, with perianal CD will be recruited. Patients with a minimum of one and a maximum of three fistula tracts.
Description of treatments: .
Subjects will receive:
Investigational product: CX-601 Suspension of adult expanded allogenic adipose-derived stem cells (eASCs) at a doses of 20 million cells and 40 million cells.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372969
|Hospital Son Dureta|
|Palma de Mallorca, Islas Baleares, Spain, 07014|
|Hospital San Juan de Dios del Aljarafe|
|Bormujos, Sevilla, Spain, 41930|
|Hospital Juan Ramón Jimenez|
|Huelva, Spain, 21005|
|Hospital Universitario La Paz|
|Madrid, Spain, 28042|
|Hospital Universitario Nuestra Señora de Valme|
|Sevilla, Spain, 41014|
|Hospital Virgen de la Macarena|
|Sevilla, Spain, 41071|
|Principal Investigator:||Damián García Olmo, MD||Hospital La Paz|