NCT01803347

Brief Summary

Efficacy of treatment of perianal fistula with mesenchymal stem cells and surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2013

Longer than P75 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2013

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

April 19, 2018

Status Verified

March 1, 2017

Enrollment Period

4.7 years

First QC Date

March 1, 2013

Last Update Submit

April 17, 2018

Conditions

Anal Fistula

Keywords

phase IIIAdipose derived stem cellsAnal fistulaCell therapyStem cell therapy

Outcome Measures

Primary Outcomes (1)

  • Safety/efficacy

    Closure of fistulas defined as absence of suppuration and re-epithelization of the external opening and absence of collections\>2 cm directly related to the fistula tract treated, as measured by MRI (healing) \[ Time Frame: weeks 1, 4, 12 and 16. Week 28 in patients with a second dose \]

    2014, march

Secondary Outcomes (1)

  • Safety/efficacy

    2015, march

Study Arms (2)

ASC + fibrin glue

EXPERIMENTAL

Intervention: drug: ASC + fibrin glue Experimental: ASCs+fibrin glue: Subjects will be treated with a dose of 100 million ASCs plus fibrin glue plus a deep curettage and closure of the internal orifice and evaluated after 16 weeks. If needed a second dose of 100 million ASCs plus fibrin glue will be applied then.

Drug: ◦Drug: ASCs. + fibrin glue

Fibrin glue

ACTIVE COMPARATOR

Intervention: fibrin glue Fibrin glue: Subjects will be treated with a dose fibrin glue plus a deep curettage and closure of the internal orifice, and evaluated after 16 weeks. If needed a second dose of fibrin glue will be applied then.

Drug: fibrin glue

Interventions

◦Drug: ASCs. + fibrin glueDRUG

Experimental group

Also known as: Experimental Drug: ASCs + fibrin glue
ASC + fibrin glue
fibrin glueDRUG

•Active Comparator: Fibrin glue Intervention: Drug: Fibrin adhesive

Fibrin glue

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signature of informed consent.
  • Complex perianal fistula cryptoglandular. Understood as a fistula in which at least one of the following circumstances is present:
  • some degree of fecal incontinence associated
  • extrasphinterics fistulas,
  • fistulas supraresfinterianas
  • high transsphincteric fistulas.
  • Patients of both genders, with more that 18 years.
  • Good overall health, according to data from the clinical history and physical examination.

You may not qualify if:

  • Patient diagnosed with inflammatory bowel disease.
  • Subjects with abscess, except if a complete cleaning of the drainage area of collections is performed and the absence of abscess and other collections larger than 2 cm in maximum diameter before treatment is started is confirmed.
  • Malignancy, except in the case of basal cell carcinoma or squamous cell skin or a history of malignancy, unless they have been found in remission during the previous 5 years.
  • Major surgery or severe trauma of the subject in the previous semester.
  • Pregnant or lactating women.
  • Adult women of childbearing potential not using effective contraception during the trial.
  • Administration of any investigational drug at present to three months prior to enrollment for this trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Clínico Lozano Blesa

Zaragoza, Aragon, 59009, Spain

Location

Hospital Clínico Universitario

Salamanca, Castille and León, 37007, Spain

Location

Hospital General Universitario

Valencia, Valencia, 46014, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Clínica Universitaria de Navarra

Pamplona, 31008, Spain

Location

Related Publications (6)

  • de la Portilla F, Alba F, Garcia-Olmo D, Herrerias JM, Gonzalez FX, Galindo A. Expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of complex perianal fistula in Crohn's disease: results from a multicenter phase I/IIa clinical trial. Int J Colorectal Dis. 2013 Mar;28(3):313-23. doi: 10.1007/s00384-012-1581-9. Epub 2012 Sep 29.

    PMID: 23053677RESULT

  • Guadalajara H, Herreros D, De-La-Quintana P, Trebol J, Garcia-Arranz M, Garcia-Olmo D. Long-term follow-up of patients undergoing adipose-derived adult stem cell administration to treat complex perianal fistulas. Int J Colorectal Dis. 2012 May;27(5):595-600. doi: 10.1007/s00384-011-1350-1. Epub 2011 Nov 9.

    PMID: 22065114RESULT

  • Garcia-Arranz M, Gomez-Pinedo U, Hardisson D, Herreros D, Guadalajara H, Garcia-Gomez I, Garcia-Verdugo JM, Garcia-Olmo D. Histopathological analysis of human specimens removed from the injection area of expanded adipose-derived stem cells. Histopathology. 2010 Jun;56(7):979-82. doi: 10.1111/j.1365-2559.2010.03573.x. No abstract available.

    PMID: 20636801RESULT

  • Garcia-Olmo D, Herreros D, Pascual I, Pascual JA, Del-Valle E, Zorrilla J, De-La-Quintana P, Garcia-Arranz M, Pascual M. Expanded adipose-derived stem cells for the treatment of complex perianal fistula: a phase II clinical trial. Dis Colon Rectum. 2009 Jan;52(1):79-86. doi: 10.1007/DCR.0b013e3181973487.

    PMID: 19273960RESULT

  • 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.

    PMID: 18694359RESULT

  • Garcia-Olmo D, Garcia-Arranz M, Herreros D, Pascual I, Peiro C, Rodriguez-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. doi: 10.1007/s10350-005-0052-6.

    PMID: 15933795RESULT

MeSH Terms

Conditions

Rectal Fistula

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Damián García-Olmo, Prof.

    Instituto de Investigación Hospital Universitario La Paz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2013

First Posted

March 4, 2013

Study Start

February 1, 2013

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

April 19, 2018

Record last verified: 2017-03

Locations

ES(5)