Long-term Safety and Efficacy of Adipose-derived Stem Cells to Treat Complex Perianal Fistulas in Patients Participating in the FATT-1 Randomized Controlled Trial

Complex Perianal Fistula Clinical Trial

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Official title:

A Prospective Study for the Assessment of the Long-term Safety and Efficacy of Cx401 in Patients Taking Part in the FATT-1 Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01020825
• Other study ID #: CX401-0303
• Secondary ID: EudraCT: 2008-00
• Status: Completed
• Start date: September 2008
• Est. completion date: May 2010

Study information

• Verified date: April 2019
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this extension is to investigate and confirm the long-term (6 months) safety and efficacy of the preceding FATT-1 trial [ClinicalTrials.gov identifier: NTC00475410], which studied patients with perianal fistula treated having received adipose-derived adult stem cell (ASC)and/or fibrin glue.

Description:

Complex perianal fistulas are a source of great distress for suffers. Treatment options are limited and surgery is often associated with incontinence and recurrence.

The biological properties of stem cells derived from adult tissues make them candidates for the treatment of pathologies requiring tissue regeneration or in diseases where the healing process is altered.

This study aims to evaluate the safety and efficacy of patients having participated within a preceding multicenter, placebo-controlled, phase 3 study [ClinicalTrials.gov identifier: NTC00475410]. The present extension aims to collect safety and efficacy data for up to 12 month from initial administration.

Fistula closure is defined as absence of suppuration through the external orifice with complete re-epithelization of the external orifice and absence of collections >2cm directly related to the fistula tract treated, as measured by MRI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: May 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 1 dose of the treatment assigned in the FATT-1 trial

• Informed consent

Exclusion Criteria:

• Other experimental drugs other than Cx401 during the follow-up period

Related Conditions & MeSH terms

• Complex Perianal Fistula
• Fistula
• Rectal Fistula

Intervention

Drug:
• ASCs
Intralesional injection of adult-stem-cells at a dose of 20 and 40 million.
• Fibrin glue
After curettage, the fistulous tract was sealed with fibrin glue.
• ASCs
Intralesional injection of adult-stem-cells at a dose of 20 and 40 million in combination with fibrin glue.

Locations

Country	Name	City	State
Spain	Hospital de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Doctor Josep Trueta	Girona
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Clínica Universitaria Navarra	Pamplona
Spain	Hospital de Sagunto	Sagunto	Valencia
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Universitario Nuestra Señora de Valme	Seville
Spain	Hospital Universitari Joan XXIII	Tarragona
Spain	Hospital Mutua de Terrasa	Terrasa	Barcelona
Spain	Hospital General Univeritario de Valencia	Valencia
Spain	Hospital Clínico Universitario "Lozano Blesa"	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Tigenix S.A.U.

Country where clinical trial is conducted

Spain, 

References & Publications (4)

García-Olmo D, García-Arranz M, García LG, Cuellar ES, Blanco IF, Prianes LA, Montes JA, Pinto FL, Marcos DH, García-Sancho L. Autologous stem cell transplantation for treatment of rectovaginal fistula in perianal Crohn's disease: a new cell-based therapy. Int J Colorectal Dis. 2003 Sep;18(5):451-4. Epub 2003 May 20. — View Citation

García-Olmo D, García-Arranz M, Herreros D, Pascual I, Peiro C, Rodríguez-Montes JA. A phase I clinical trial of the treatment of Crohn's fistula by adipose mesenchymal stem cell transplantation. Dis Colon Rectum. 2005 Jul;48(7):1416-23. — View Citation

Garcia-Olmo D, Garcia-Arranz M, Herreros D. Expanded adipose-derived stem cells for the treatment of complex perianal fistula including Crohn's disease. Expert Opin Biol Ther. 2008 Sep;8(9):1417-23. doi: 10.1517/14712598.8.9.1417 . Review. — View Citation

Garcia-Olmo D, Herreros D, Pascual M, Pascual I, De-La-Quintana P, Trebol J, Garcia-Arranz M. Treatment of enterocutaneous fistula in Crohn's Disease with adipose-derived stem cells: a comparison of protocols with and without cell expansion. Int J Colorectal Dis. 2009 Jan;24(1):27-30. doi: 10.1007/s00384-008-0559-0. Epub 2008 Aug 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of adverse events (clinical or laboratory) attributed to the study therapy in the preceding FATT-1 randomized trial (CX401 or fibrin glue)		6 months (since last visit in FATT-1 trial)
Secondary	Closure of the fistula (defined as suppuration through the external opening of the fistula spontaneously and on pressure, complete re-epithelization of the external opening in the clinical evaluation and absence of collections >2 cm in MRI)		6 months (since last visit of FATT-1 trial)