Crohn's FistulaNCT05742100
Darvadstrocel for Crohn's Fistula in the Realworld
An observational study of Crohn's Fistula, run by Dolores Herreros Marcos at 1 site in Spain.
Trial summary
Background Perianal fistula may affect 15-50% of patients with Crohn's disease (CD). Treatment is complex, requiring a multidisciplinary approach. Darvadstrocel (allogeneic mesenchymal cells obtained from lipoaspirates) was approved in 2018 by the European Medicines Agency and Spanish Agency of Medicines and Medical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Fistula
- What is being tested?
- Darvadstrocel
- How many people
- 73 participants
- Where
- 1 siteSpain
- Study dates
- 29 Nov 2019to 21 Apr 2022
- 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: All patients with complex anorectal fistulas associated with CD treated with darvadstrocel in the 14 dedicated centres from 29 November 2019 to 21 April2022 will be enrolled in the study.
Who may be able to join
- 1)complex fistula in a patient with CD
- 2)failure of conventional and anti-tumour necrosis factor treatment
- 3)absence of collection s>2cm confirmed by pelvic MRI scan at the time of surgery
Who cannot join
- Patients with a diagnosis of rectovaginal fistula, rectal stenosis or severe active proctitis were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Darvadstrocel (Allogenic Stem Cell Therapy) for Crohn's Fistula in Real Clinical Practice: the National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study)
Background Perianal fistula may affect 15-50% of patients with Crohn's disease (CD). Treatment is complex, requiring a multidisciplinary approach. Darvadstrocel (allogeneic mesenchymal cells obtained from lipoaspirates) was approved in 2018 by the European Medicines Agency and Spanish Agency of Medicines and Medical Products as a treatment for fistulas in CD. Recent European Crohn's and Colitis Organisation (ECCO) andSpanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) guidelines state that darvadstrocel is effective with a favourable safety profile,with a strong level of evidence (level 2).With this study we want to see the real efficacy of darvadstrocel in a Spanish population after 6 months of follow-up.
Read the detailed description
Methods: The criteria for the Spanish National Health System to fund darvadstrocel treatment are: 1)complex fistula in a patient with CD; 2)failure of conventional and anti-tumour necrosis factor treatment; and 3)absence of collection s>2cm confirmed by pelvic MRI scan at the time of surgery. From November 2019 to April 2022, 73 patients were treated with darvadstrocel at 14Spanish centres and evaluated clinically and radiologically 6 months after treatment.
- Conditions
- Crohn's Fistula
- Being tested
- Darvadstrocel
- Keywords
- Adipose-derived stem cells, Cell therapy, Compassionate use, Crohn's disease, Fistula-in-ano
- Medical subject headings
- Crohn Disease, Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarvadstrocelDrug
expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas
| Study group | Role | What they receive |
|---|---|---|
| Group of patients treated with darvadstrocel | Not described Receives: Drug: Darvadstrocel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with clinical remission
Clinical remission was defined as closure of all previously draining external openings treated with darvadstrocel, despite gentle finger compression
Measured: 6-month
Number of Participants with clinical response
Clinical response was defined as closure of ≥50% of previously draining external openings treated with darvadstrocel, despite gentle finger compression
Measured: 6-month
Number of Participants with clinical radiographic healing
Complete radiographic healing was defined as an MRI result with no fluid collection >2cm in all dimensions, no oedema and no inflammation nor sign of active inflammatory response;a remnant fistula tract scar may remain
Measured: 6-month
Number of Participants with combined clinical-radiological response
Combined clinical-radiological response, a new concept, was used to describe patients who achieved both clinical remission and complete radiological healing.
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start29 Nov 2019
- Primary completion21 Apr 2022
- Study completion21 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dolores Herreros Marcos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dolores Herreros Marcos, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Investigators
- Dolores Herreros, Principal investigator, Hospital Fundación Jiménez Diaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742100
- Sponsor's protocol ID
- Darvastrocel Prime Study 001
- Status last verified
- Feb 2023
- First submitted
- 10 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Herreros MD, Ramirez JM, Otero-Pineiro AM, Marti-Gallostra M, Badiola I, Enriquez-Navascues JM, Millan M, Barreiro EM, De La Portilla F, Suarez Alecha J, Garcia-Olmo D; National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study) Group. Use of Darvadstrocel (Allogenic Stem Cell Therapy) for Crohn's Fistulas in Real Clinical Practice: The National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study). Dis Colon Rectum. 2024 Jul 1;67(7):960-967. doi: 10.1097/DCR.0000000000003216. Epub 2024 Apr 11.
PubMed 38603800
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Darvadstrocel (Allogenic Stem Cell Therapy) for Crohn's Fistula in Real Clinical Practice: the National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study)
- ClinicalTrials.gov ID
- NCT05742100
- Acronym / sponsor ID
- Darvastrocel Prime Study 001
- Conditions
- Crohn's Fistula
- Keywords
- Adipose-derived stem cells, Cell therapy, Compassionate use, Crohn's disease, Fistula-in-ano
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Dolores Herreros MarcosUniversity, hospital or other
- Study start
- 29 Nov 2019 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 21 Apr 2022 (actual)
- First posted
- 23 Feb 2023 (actual)
- 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.
Background Perianal fistula may affect 15-50% of patients with Crohn's disease (CD). Treatment is complex, requiring a multidisciplinary approach. Darvadstrocel (allogeneic mesenchymal cells obtained from lipoaspirates) was approved in 2018 by the European Medicines Agency and Spanish Agency of Medicines and Medical Products as a treatment for fistulas in CD. Recent European Crohn's and Colitis Organisation (ECCO) andSpanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) guidelines state that darvadstrocel is effective with a favourable safety profile,with a strong level of evidence (level 2).With this study we want to see the real efficacy of darvadstrocel in a Spanish population after 6 months of follow-up.
Detailed description
Methods: The criteria for the Spanish National Health System to fund darvadstrocel treatment are: 1)complex fistula in a patient with CD; 2)failure of conventional and anti-tumour necrosis factor treatment; and 3)absence of collection s>2cm confirmed by pelvic MRI scan at the time of surgery. From November 2019 to April 2022, 73 patients were treated with darvadstrocel at 14Spanish centres and evaluated clinically and radiologically 6 months after treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group of patients treated with darvadstrocel | – | Drug: Darvadstrocel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with complex anorectal fistulas associated with CD treated with darvadstrocel in the 14 dedicated centres from 29 November 2019 to 21 April2022 will be enrolled in the study.
Key inclusion criteria (3 listed)
- 1)complex fistula in a patient with CD
- 2)failure of conventional and anti-tumour necrosis factor treatment
- 3)absence of collection s>2cm confirmed by pelvic MRI scan at the time of surgery
Key exclusion criteria (1 listed)
- Patients with a diagnosis of rectovaginal fistula, rectal stenosis or severe active proctitis were excluded
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 |
|---|---|---|
| Darvadstrocelexpanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas | Drug | Group of patients treated with darvadstrocel |
Primary outcome
Number of Participants with clinical remission
Time frame: 6-month
Clinical remission was defined as closure of all previously draining external openings treated with darvadstrocel, despite gentle finger compression
Number of Participants with clinical response
Time frame: 6-month
Clinical response was defined as closure of ≥50% of previously draining external openings treated with darvadstrocel, despite gentle finger compression
Number of Participants with clinical radiographic healing
Time frame: 6-month
Complete radiographic healing was defined as an MRI result with no fluid collection >2cm in all dimensions, no oedema and no inflammation nor sign of active inflammatory response;a remnant fistula tract scar may remain
Number of Participants with combined clinical-radiological response
Time frame: 6-month
Combined clinical-radiological response, a new concept, was used to describe patients who achieved both clinical remission and complete radiological healing.
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 23 Feb 2023.
- Derived from this study: PubMed 38603800Herreros MD, Ramirez JM, Otero-Pineiro AM, Marti-Gallostra M, Badiola I, Enriquez-Navascues JM, Millan M, Barreiro EM, De La Portilla F, Suarez Alecha J, Garcia-Olmo D; National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study) Group. Use of Darvadstrocel (Allogenic Stem Cell Therapy) for Crohn's Fistulas in Real Clinical Practice: The National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study). Dis Colon Rectum. 2024 Jul 1;67(7):960-967. doi: 10.1097/DCR.0000000000003216. Epub 2024 Apr 11.
Related trials for Crohn's Fistula
RecruitingPhase 4
Risankizumab for Refractory Perianal Fistulizing Crohn's Disease
Crohn Disease, Perianal Fistula
Recruiting
A Study Comparing Transperineal Ultrasound, Magnetic Resonance Imaging, Endoscopic Ultrasound, and Examination Under Anesthesia to Detect and Classify Perianal Fistulas in Patients With Crohn's Disease or Fistulas of Unknown Cause
Crohn Disease (CD), Cryptoglandular Perianal Fistula
Not yet recruitingPhase 4
MIRICURE: Mirikizumab With Curettage and Repair (Closure) for Perianal Fistulizing Crohn's Disease
Crohn's Disease, Perianal Fistula
RecruitingObservational study
Exclusive Enteral Nutrition Therapy for Active and Complicated Crohn's Disease
Crohn's Disease
RecruitingObservational study
Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells
Crohn Disease, Anal Fistula
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.
Dolores Herreros principal investigator
Hospital Fundación Jiménez Diaz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Fistula, run by Dolores Herreros Marcos at 1 site 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 3 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 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of Participants with clinical remission (time frame: 6-month). The study lists 4 primary outcomes in all. 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 NCT05742100, which also lists 1 linked publication.
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 23 Feb 2023.