We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    Cx601

Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients With Crohn's Disease (ADMIRE-CD-II)

This study is currently recruiting participants.
Verified November 2017 by Cellerix ( TiGenix S.A.U. )
Sponsor:
ClinicalTrials.gov Identifier:
NCT03279081
First Posted: September 12, 2017
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Cellerix ( TiGenix S.A.U. )
  Purpose
The purpose of this phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn's disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study

Condition Intervention Phase
Crohn's Disease Drug: Cx601 Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Phase-III Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicentre Study to Assess Efficacy and Safety of Cx601, Allogeneic Expanded Adipose-derived Stem Cells for Complex Perianal Fistula(s) in Crohn's Disease.ADMIRE-CD-II

Resource links provided by NLM:


Further study details as provided by Cellerix ( TiGenix S.A.U. ):

Primary Outcome Measures:
  • Combined Remission of complex perianal fistula(s) [ Time Frame: By week 24 ]
    Combined Remission of complex perianal fistula(s) at week 24


Secondary Outcome Measures:
  • Efficacy of Cx601 - Clinical remission (closure of 100%) [ Time Frame: By week 24 ]
    Clinical remission (i.e. closure of all treated external openings that were draining at baseline despite gentle finger compression) at week 24

  • Efficacy of Cx601 - Clinical remission (closure of 100%) [ Time Frame: By week 52 ]
    Clinical remission (i.e. closure of all treated external openings that were draining at baseline, despite gentle finger compression) at week 52

  • Efficacy of Cx601 - Clinical response (closure of 50% or more) [ Time Frame: By week 24 ]
    Clinical response (i.e. closure of at least 50% of all treated external openings that were draining at baseline, despite gentle finger compression) at week 24

  • Efficacy of Cx601 - Clinical response (closure of 50% or more) [ Time Frame: By week 52 ]
    Clinical response (i.e. closure of at least 50% of all treated external openings that were draining at baseline, despite gentle finger compression) at week 52

  • Percentage of Adverse Events, Serious Adverse Events, and their severity summarised according to MedDRA dictionnary by week 24. [ Time Frame: By week 24 ]
    Percentage of Adverse Events, Serious Adverse Events, and their severity summarised according to MedDRA dictionnary by week 24.

  • Percentage of Adverse Events, Serious Adverse Events, and their severity summarised according to MedDRA dictionnary by week 52. [ Time Frame: By week 52 ]
    Percentage of Adverse Events, Serious Adverse Events, and their severity summarised according to MedDRA dictionnary by week 52.


Estimated Enrollment: 326
Actual Study Start Date: September 15, 2017
Estimated Study Completion Date: October 15, 2021
Estimated Primary Completion Date: October 1, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cx601
120 million cells administered by intralesional administration
Drug: Cx601
Allogenic eASCs 5 million cells/ml - suspension for injection Cx601
Placebo Comparator: Placebo
matching placebo administered by intralesional administration
Other: Placebo
Solution for injection

Detailed Description:

The current multicentre phase III study is proposed to evaluate the efficacy and safety of Cx601 compared to placebo for the treatment of complex perianal fistula(s) in patients with Crohn's disease at Week 24 with a follow-up period up to 52 weeks.

The primary efficacy analysis, will be conducted at Week 24 timepoint. The double blind design will be maintained up to Week 52 (both patient and investigator) by a specific blinding for study treatment administration and for evaluating its efficacy .

The study will follow an add-on design, patients receiving any ongoing concomitant medical treatment, at stable doses at the time of screening, for the Crohn's disease (CD) will be allowed to continue it throughout the study.

Study treatments will be allocated, on a 1:1 ratio, by central randomization through interactive web response system (IWRS).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent
  2. Patients of either gender ≥ 18 years and ≤75 years of age
  3. Patients with Crohn's Disease (CD) diagnosed at least 6 months prior to Screening visit in accordance with accepted clinical, endoscopic, histological and/or radiological criteria
  4. Presence of complex perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings
  5. Clinically controlled, non active or mildly active CD, during the last six months prior to Screening visit.
  6. Patients whose perianal fistulas were previously treated and have shown an inadequate response or a loss of response while they were receiving either an immunosuppressive agent or TNF-α antagonist or vedolizumab or ustekinumab, or having documented intolerance
  7. Women of childbearing potential (WCBP) must have negative serum pregnancy test at screening (sensitive to 25 IU human chorionic gonadotropin [hCG]). Both WCBP or male patients participating in this study, with a WCBP as partner, must agree to use an adequate method of contraception during the entire duration of the study.

Exclusion Criteria:

  1. Concomitant rectovaginal or rectovesical fistula(s)
  2. Patient naïve to prior specific medical treatment for perianal complex fistula(s) including IS or anti-TNFs.
  3. Presence of a perianal collection > 2 cm in at least two dimensions on the central reading MRI at Screening visit that was not adequately drained as confirmed by the surgeon
  4. Severe rectal and/or anal stenosis that make impossible to follow the surgical protocol
  5. Patient with diverting stomas
  6. Active, uncontrolled infection requiring parenteral antibiotics
  7. Patient with ongoing systemic or rectal steroids for CD in the last 2 weeks prior to Screening visit
  8. Patients with major alteration on any of the following laboratory tests or increased risk for the surgical procedure:

    1. Serum creatinine levels >1.5 upper limit of normality (ULN)
    2. Total bilirubin >1.5 ULN
    3. AST/ALT >3.0 ULN
    4. Hemoglobin <10.0 g/dL
    5. Platelets <75.0 x109/L
    6. Albuminemia < 3.0 g/dL
  9. Suspected or documented infectious enterocolitis within two weeks prior to Screening visit
  10. Any prior invasive malignancy diagnosed within the last 5 years prior to Screening visit. Patients with basal-cell carcinoma of the skin completely resected outside the perineal region can be included
  11. Current or recent (within 6 months prior to the Screening visit) history of severe, progressive, and/or uncontrolled hepatic, haematological, gastrointestinal (other than CD), renal, endocrine, pulmonary, cardiac, neurological or psychiatric disease that may result in patients increased risk from study participation and/or lack of compliance with study procedures
  12. Patients with primary sclerosing cholangitis
  13. Patients with known chronically active hepatopathy of any origin, including cirrhosis and patients with persistent positive HBV surface antigen (HBsAg) and quantitative HBV polymerase chain reaction (PCR), or positive serology for HCV and quantitative HCV PCR within 6 months prior to Screening.
  14. Congenital or acquired immunodeficiencies, including patients known to be HIV carriers
  15. Known allergies or hypersensitivity to penicillin or aminoglycosides; DMEM (Dulbecco Modified Eagle's Medium); bovin serum; local anaesthetics or gadolinium (MRI contrast)
  16. Contraindication to MRI scan (e.g., due to the presence of pacemakers, hip replacements or severe claustrophobia)
  17. Major surgery or severe trauma within 6 months prior to Screening visit
  18. Pregnant or breastfeeding women
  19. Patients who do not wish to or cannot comply with study procedures
  20. Patients currently receiving, or having received any investigational drug for CD or the perianal fistula(s) within 3 months prior to Screening visit
  21. Patients previously treated with Cx601 or other allogeneic stem-cell therapy cannot be enrolled into this clinical study
  22. Surgery of one or more segments of the colon or terminal ileum within 3 months prior to Screening visit
  23. Patients who had local perianal surgery other than drainage for the fistula within 6 months prior to the Screening visit, or those who may need surgery in the perianal region for reasons other than fistulas at the time of inclusion in the study, or for whom such major surgery is foreseen in this region in the 24 weeks following treatment administration at the time of screening
  24. Contraindication to the anaesthetic procedure
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279081


Locations
Spain
Hospital Clínic i Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Panés    +34932275400    jpanes@clinic.cat   
Hospital Universitario Puerta de Hierro Majadahonda Not yet recruiting
Madrid, Spain
Contact: Vera    +34911916000    farmacologia_clinica@idiphim.org   
Sponsors and Collaborators
TiGenix S.A.U.
  More Information

Responsible Party: TiGenix S.A.U.
ClinicalTrials.gov Identifier: NCT03279081     History of Changes
Other Study ID Numbers: Cx601-0303
2017-000725-12 ( EudraCT Number )
First Submitted: July 21, 2017
First Posted: September 12, 2017
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Cellerix ( TiGenix S.A.U. ):
Crohn's disease
complex perianal fistula(s)

Additional relevant MeSH terms:
Crohn Disease
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical