Crohn DiseaseNCT05322057
Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease
An observational study of Crohn Disease and Fistula Perianal, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn's disease. However, due to limited clinical data, this multicentre, nationwide study aimed to assess its clinical efficacy in closing complex anal fistula. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Crohn Disease, Fistula Perianal
- What is being tested?
- Darvadstrocel
- Type of treatment
- Injection or infusion
- How many people
- 14 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2018to 1 Dec 2021
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: 14 patients with Crohn's disease and complex fistula got enrolled in this study.
Who may be able to join
- patients aged 18 and older who had a non-active or mildly active luminal CD with complex fistula with a maximum of two internal and three external fistulas
Who cannot join
- rectovaginal fistulas
- rectal and/or anal stenosis
- active proctitis
- diverting stomas
- an abscess (<2cm) that was not drained at the fistula preperation visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease - a Prospective Nationwide Multicentre Study
The use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn's disease. However, due to limited clinical data, this multicentre, nationwide study aimed to assess its clinical efficacy in closing complex anal fistula.
Read the detailed description
Fifteen applications in 14 patients (3 male, 11 female) with complex anal fistulas treated in three tertiary hospitals in Austria were included between October 2018 and April 2021. Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells (Cx601 - Darvadstrocel, Alofisel®) was performed in each patient. Closure of the external fistula opening without secretion by finger compression was defined as success.
- Conditions
- Crohn Disease, Fistula Perianal
- Being tested
- Darvadstrocel
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarvadstrocelDrug
Also called Alofisel
Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells around the fistula opening and around the fistula tract
| Study group | Role | What they receive |
|---|---|---|
| patients with Crohn's disease and complex perianal fistula | 14 patients with Crohn's disease refractory to standard treatment for complex perianal fistula got enrolled in this study. Receives: Drug: Darvadstrocel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula Closure
The study's primary endpoint was established at week 52 with clinically assessed fistula closure.
Measured: 1 year
Secondary outcomes (2)
Evaluation of perianal disease
At every follow up visit the perianal disease was evaluated using the PDAI (Perianal disease activity index)
Measured: 1 year
Evaluation of Crohn's disease
Crohn's disease was evaluated by using the HBI (Harvey Bradshaw Index)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 Oct 2018
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christopher Dawoud, Medical University of Vienna
- Investigators
- Stefan Riss, Prof.MD, Study chair, Medical University of Vienna, Head of Pelvic Floor Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322057
- Sponsor's protocol ID
- 1682/2018
- Status last verified
- Apr 2022
- First submitted
- 3 Apr 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can be shared just in anonymised form in case of an ethical agreement with other researches.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease - a Prospective Nationwide Multicentre Study
- ClinicalTrials.gov ID
- NCT05322057
- Acronym / sponsor ID
- 1682/2018
- Conditions
- Crohn Disease, Fistula Perianal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 11 Apr 2022 (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.
The use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn's disease. However, due to limited clinical data, this multicentre, nationwide study aimed to assess its clinical efficacy in closing complex anal fistula.
Detailed description
Fifteen applications in 14 patients (3 male, 11 female) with complex anal fistulas treated in three tertiary hospitals in Austria were included between October 2018 and April 2021. Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells (Cx601 - Darvadstrocel, Alofisel®) was performed in each patient. Closure of the external fistula opening without secretion by finger compression was defined as success.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with Crohn's disease and complex perianal fistula | – | Drug: Darvadstrocel14 patients with Crohn's disease refractory to standard treatment for complex perianal fistula got enrolled in this study. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 14 patients with Crohn's disease and complex fistula got enrolled in this study.
Key inclusion criteria (1 listed)
- patients aged 18 and older who had a non-active or mildly active luminal CD with complex fistula with a maximum of two internal and three external fistulas
Key exclusion criteria (5 listed)
- rectovaginal fistulas
- rectal and/or anal stenosis
- active proctitis
- diverting stomas
- an abscess (<2cm) that was not drained at the fistula preperation visit
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 |
|---|---|---|
| DarvadstrocelAlso: AlofiselInjection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells around the fistula opening and around the fistula tract | Drug | patients with Crohn's disease and complex perianal fistula |
Primary outcome
Fistula Closure
Time frame: 1 year
The study's primary endpoint was established at week 52 with clinically assessed fistula closure.
2 secondary outcomes
Evaluation of perianal disease
Time frame: 1 year
Evaluation of Crohn's disease
Time frame: 1 year
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 11 Apr 2022.
- Individual participant dataSharing planned: No. IPD can be shared just in anonymised form in case of an ethical agreement with other researches.
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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.
Stefan Riss, Prof.MD study chair
Medical University of Vienna, Head of Pelvic Floor Surgery
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 Disease and Fistula Perianal, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 5 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 11 Apr 2022. 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 Austria. 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?
Fistula Closure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2022.