Complex Perianal FistulaLTENCT01020825
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
An observational study of Complex Perianal Fistula, run by Tigenix S.A.U. at 15 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Perianal Fistula
- What is being tested?
- ASCs and Fibrin glue
- Type of treatment
- Injection or infusion
- How many people
- 148 participants
- Where
- 15 sitesSpain
- Study dates
- Sep 2008to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that received at least one treatment dose in study Cx401/FATT1
Who may be able to join
- At least 1 dose of the treatment assigned in the FATT-1 trial
- Informed consent
Who cannot join
- Other experimental drugs other than Cx401 during the follow-up period
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Hospital de Fuenlabrada
Fuenlabrada, Madrid, 28942
Hospital Doctor Josep Trueta
Girona, 17007
Hospital Gregorio Marañón
Madrid, 28007
Hospital Clínico San Carlos
Madrid, 28040
Hospital 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Clínica Universitaria Navarra
Pamplona, 31008
Hospital de Sagunto
Sagunto, Valencia, 46520
Hospital Universitario de Salamanca
Salamanca, 37007
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Universitario Nuestra Señora de Valme
Seville, 41014
Hospital Universitari Joan XXIII
Tarragona, 17300
Hospital Mutua de Terrasa
Terrassa, Barcelona, 08221
Hospital General Univeritario de Valencia
Valencia, 46014
Hospital Clínico Universitario "Lozano Blesa"
Zaragoza, 50009
About this study
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
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.
Read the detailed 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.
- Conditions
- Complex Perianal Fistula
- Being tested
- ASCs, Fibrin glue
- Keywords
- Complex perianal fistula, Adipose-derived adult stem cells, Fibrin glue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASCsDrug
Also called Cx401 (company code), Ontaril®
Intralesional injection of adult-stem-cells at a dose of 20 and 40 million.
Fibrin glueDrug
After curettage, the fistulous tract was sealed with fibrin glue.
ASCsDrug
Also called Cx401 (company code), Ontaril®
Intralesional injection of adult-stem-cells at a dose of 20 and 40 million in combination with fibrin glue.
| Study group | Role | What they receive |
|---|---|---|
| ASCs | Patients randomized to experimental treatment (ASC transplantation) in the FATT-1 randomized controlled trial [ClinicalTrials.gov identifier: NTC00475410] Receives: Drug: ASCs | |
| Fibrin glue | Patients randomized to the control treatment (application of fibrin glue) in the FATT-1 randomized controlled trial [ClinicalTrials.gov identifier: NTC00475410] Receives: Drug: Fibrin glue | |
| ASCs + Fibrin Glue | Patients randomized to the control treatment (application of fibrin glue) + intralesional injection of ASCs in the FATT-1 randomized controlled trial [ClinicalTrials.gov identifier: NTC00475410] Receives: Drug: ASCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of adverse events (clinical or laboratory) attributed to the study therapy in the preceding FATT-1 randomized trial (CX401 or fibrin glue)
Measured: 6 months (since last visit in FATT-1 trial)
Secondary outcomes (1)
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)
Measured: 6 months (since last visit of FATT-1 trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study startSep 2008
- Primary completionMar 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Complex Perianal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tigenix S.A.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Damián García-Olmo, MD, Principal investigator, General Surgery Department, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020825
- Sponsor's protocol ID
- CX401-0303
- Other IDs
- EudraCT: 2008-003140-10
- Acronym
- LTE
- Status last verified
- Apr 2019
- First submitted
- 25 Nov 2009
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Garcia-Olmo D, Garcia-Arranz M, Garcia LG, Cuellar ES, Blanco IF, Prianes LA, Montes JA, Pinto FL, Marcos DH, Garcia-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. doi: 10.1007/s00384-003-0490-3. Epub 2003 May 20.
PubMed 12756590Garcia-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.
PubMed 15933795Garcia-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.
PubMed 18696086Garcia-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.
PubMed 18694359Herreros MD, Garcia-Arranz M, Guadalajara H, De-La-Quintana P, Garcia-Olmo D; FATT Collaborative Group. Autologous expanded adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistulas: a phase III randomized clinical trial (FATT 1: fistula Advanced Therapy Trial 1) and long-term evaluation. Dis Colon Rectum. 2012 Jul;55(7):762-72. doi: 10.1097/DCR.0b013e318255364a.
PubMed 22706128
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01020825
- Acronym / sponsor ID
- LTE / CX401-0303
- Conditions
- Complex Perianal Fistula
- Keywords
- Complex perianal fistula, Adipose-derived adult stem cells, Fibrin glue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Tigenix S.A.U.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 26 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASCs | – | Drug: ASCsPatients randomized to experimental treatment (ASC transplantation) in the FATT-1 randomized controlled trial [ClinicalTrials.gov identifier: NTC00475410] |
| Fibrin glue | – | Drug: Fibrin gluePatients randomized to the control treatment (application of fibrin glue) in the FATT-1 randomized controlled trial [ClinicalTrials.gov identifier: NTC00475410] |
| ASCs + Fibrin Glue | – | Drug: ASCsPatients randomized to the control treatment (application of fibrin glue) + intralesional injection of ASCs in the FATT-1 randomized controlled trial [ClinicalTrials.gov identifier: NTC00475410] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that received at least one treatment dose in study Cx401/FATT1
Key inclusion criteria (2 listed)
- At least 1 dose of the treatment assigned in the FATT-1 trial
- Informed consent
Key exclusion criteria (1 listed)
- Other experimental drugs other than Cx401 during the follow-up period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASCsAlso: Cx401 (company code), Ontaril®Intralesional injection of adult-stem-cells at a dose of 20 and 40 million. | Drug | ASCs |
| Fibrin glueAfter curettage, the fistulous tract was sealed with fibrin glue. | Drug | Fibrin glue |
| ASCsAlso: Cx401 (company code), Ontaril®Intralesional injection of adult-stem-cells at a dose of 20 and 40 million in combination with fibrin glue. | Drug | ASCs + Fibrin Glue |
Primary outcome
Cumulative incidence of adverse events (clinical or laboratory) attributed to the study therapy in the preceding FATT-1 randomized trial (CX401 or fibrin glue)
Time frame: 6 months (since last visit in FATT-1 trial)
1 secondary outcome
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)
Time frame: 6 months (since last visit of FATT-1 trial)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Background: PubMed 12756590Garcia-Olmo D, Garcia-Arranz M, Garcia LG, Cuellar ES, Blanco IF, Prianes LA, Montes JA, Pinto FL, Marcos DH, Garcia-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. doi: 10.1007/s00384-003-0490-3. Epub 2003 May 20.
- Background: PubMed 15933795Garcia-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.
- Background: PubMed 18696086Garcia-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.
- Background: PubMed 18694359Garcia-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.
- Derived from this study: PubMed 22706128Herreros MD, Garcia-Arranz M, Guadalajara H, De-La-Quintana P, Garcia-Olmo D; FATT Collaborative Group. Autologous expanded adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistulas: a phase III randomized clinical trial (FATT 1: fistula Advanced Therapy Trial 1) and long-term evaluation. Dis Colon Rectum. 2012 Jul;55(7):762-72. doi: 10.1097/DCR.0b013e318255364a.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damián García-Olmo, MD principal investigator
General Surgery Department, Hospital Universitario La Paz
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Perianal Fistula, run by Tigenix S.A.U. at 15 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of adverse events (clinical or laboratory) attributed to the study therapy in the preceding FATT-1 randomized trial (CX401 or fibrin glue) (time frame: 6 months (since last visit in FATT-1 trial)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01020825, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.