Crohn's DiseasePhase 3NCT04701411
A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's Disease
A Phase 3 study testing Darvadstrocel in people with Crohn's Disease and Complex Perianal Fistula, run by Takeda at 22 sites in 5 countries.
Trial summary
A perianal fistula is an abnormal passageway that develops between the rectum and the skin near the anus. The fistula is considered complex if it branches into several openings or an abscess is also present. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Crohn's Disease, Complex Perianal Fistula
- What is being tested?
- Darvadstrocel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 30 Jun 2021to 7 May 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Has a CD diagnosis based on accepted clinical, endoscopic, histological and/or radiologic criteria at least 6 months before the screening visit.
- Has complex perianal fistula refractory to at least one of the following treatments: immunosuppressants or biologics (anti-TNFs, anti-integrin, anti-interleukin [IL] 12/23). Fistula(s) refractory to therapy is defined in this study as follows: Immunosuppressants: Inadequate response after 3 months, based on clinical assessment, or more treatment with azathioprine, 6-mercaptopurine or methotrexate. Biologics: Inadequate response after 14 weeks (16 weeks for anti-IL 12/23), based on clinical assessment, or more standard treatment for induction and maintenance.
- A complex perianal fistula(s) that meets one or more of the following criteria, modified from the American Gastroenterological Association (AGA) technical review: High intersphincteric, transsphincteric, extrasphincteric, or suprasphincteric as assessed by MRI. Presence of 2 or 3 external openings (tracts) as assessed by clinical examination. Associated fluid (abscess) collections as determined by MRI.
- This study requires that the participant has complex perianal fistulas with a maximum of 2 internal openings and a maximum of 3 external openings, based on clinical assessment. Darvadstrocel treatment is targeted for fistulas that connect between internal and external openings. A central reading of a locally performed pelvic MRI will be performed to confirm the location of the fistula and potential associated perianal abscess(es). Fistulas must have been draining for at least 6 weeks before the screening visit. Participants with actively draining simple subcutaneous fistulas, at the time of the screening visit, are not allowed in this study.
- Has inactive or mildly active luminal CD defined by meeting all of the following criteria:
- Colonoscopy, flexible sigmoidoscopy or rectoscopy performed either at screening or within the 6 months before screening, demonstrating no rectal ulcers larger than 0.5 cm. A participant who has documented rectal ulcers larger than 0.5 cm within the 6 months before screening but has undergone subsequent treatment may be eligible if there are no rectal ulcers larger than 0.5 cm on a sigmoidoscopy or rectoscopy performed after treatment or at the time of screening.
- The improvement of, or no worsening in stool frequency, sustained for 1 week or more, in the interval between the colonoscopy, flexible sigmoidoscopy or rectoscopy in inclusion criteria 4(a) and the screening visit.
- No initiation or intensification of treatment with corticosteroids, immunosuppressants, or monoclonal antibody dose regimen between the colonoscopy, flexible sigmoidoscopy or rectoscopy in inclusion criteria 4(a) and the screening visit.
Who cannot join
- Has received any investigational compound within 12 weeks/84 days before screening.
- Has received darvadstrocel/eASC in a previous clinical study or as a therapeutic agent.
- The participant weighs <10 kg at screening.
- Has concomitant perianal fistula(s) with only internal or external opening(s).
- Has concomitant internal fistula(s) such as ileo-vesical, rectovaginal or ileo-colonic fistula(s).
- Has an abscess >2 cm, unless resolved in the preparation procedure.
Show all 20Show fewer
- Has rectal and/or anal stenosis, and/or active proctitis, which would restrict the surgical procedure.
- The participant underwent surgery for the fistula other than drainage or seton placement.
- Has diverting stomas.
- Has ongoing systemic corticosteroid treatment or has been treated with systemic corticosteroids within 4 weeks before screening.
- The participant requires new treatment with immunosuppressants/anti-TNF agents during the screening period.
- The participant has known or suspected COVID-19 by the investigator within the past 2 months (additional testing may be performed at the discretion of the investigator). Positive antibody testing for COVID without other evidence of current or recent active infection does not exclude participation. Participants who were in screening at the time that COVID-19-related factors resulted in discontinuation may also be rescreened with approval of the sponsor or designee.
- The participant requires surgery in the perianal region for reasons other than fistulas at the time of screening or foreseen either during the study and/or during the 24 weeks after treatment administration.
- Has malignant tumor or a prior history of any malignant tumor, including any type of fistula carcinoma.
- Has current or recent (within 3 months before the screening) history of abnormal, severe, progressive, uncontrolled hepatic, hematologic, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral disease.
- Has either congenital or acquired immunodeficiencies, including participants known to be HIV carriers or participants with, in the judgment of the investigator, are suspected to have monogenic inflammatory bowel disease.
- Has previously received a bone marrow transplant.
- Has a contraindication to MRI scan or other planned study procedures.
- Has a contraindication to the anesthetic procedure.
- Had major surgery or severe trauma within 6 months before the screening visit.
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
Spain6 sites
Hospital Universitari Germans Trias i Pujol
Badalona, 8916
Hospital Universitari Vall d'Hebron
Barcelona, 8035
Hospital Sant Joan de Deu
Barcelona, 8950
Hospital Infantil Universitario Nino Jesus
Madrid, 28009
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Hospital Materno-Infantil de Malaga
Málaga, 29011
Israel5 sites
Shamir Medical Center (Assaf Harofeh)
Be’er Ya‘aqov, 7033001
Rambam Health Care Campus
Haifa, 3109601
Shaare Zedek Medical Center
Jerusalem, 91031
Hadassah University Hospital-Mt. Scopus
Jerusalem, 9124001
Schneider Children's Medical Center
Petah Tikva, 4920235
Japan5 sites
Juntendo University Hospital
Bunkyō City, 113-8431
Medical Hospital, Tokyo Medical and Dental University
Bunkyō City, 113-8519
Miyagi Children's Hospital
Sendai, 989-3126
Jichi Medical University Hospital
Shimotsuke-shi, 329-0498
Mie University Hospital
Tsu, 514-8507
Netherlands3 sites
Amsterdam UMC, Locatie AMC
Amsterdam, 1105 AZ
Universitair Medisch Centrum Groningen (UMCG)
Groningen, 9713 GZ
Erasmus Medisch Centrum
Rotterdam, 3000 CA
Poland3 sites
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, 30-663
Gabinet Lekarski Bartosz Korczowski
Rzeszów, 35-302
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warsaw, 04-730
About this study
Official title: A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Subjects With Crohn's Disease Over a Period of 24 Weeks and an Extended Follow-up Period for a Total of up to 52 Weeks
A perianal fistula is an abnormal passageway that develops between the rectum and the skin near the anus. The fistula is considered complex if it branches into several openings or an abscess is also present.
The main aim of this study is to learn if complex perianal fistulas in children and teenagers close after treatment with darvadstrocel.
Read more
2 to 3 weeks before treatment with darvadstrocel, each participant will have surgery to clean the fistula and to drain any abscesses. On the day of treatment, each participant will have the fistula cleaned and will receive an injection of darvadstrocel near the fistula, under anesthetic.
For up to 1 year after treatment, participants will regularly visit the clinic for follow-up. The fistula will be examined and any side effects from the treatment will be recorded. Participants will have an MRI at one clinic visit (about 24 weeks after treatment).
Read the detailed description
The drug being tested in this study is called darvadstrocel (Cx601, cell suspension containing 120 million cells of allogeneic expanded adipose-derived mesenchymal stem cells [eASCs]). Darvadstrocel is being tested to treat complex perianal fistula in pediatric participants who have Crohn's disease (CD). This study will look at the safety and efficacy of darvadstrocel in the treatment of complex perianal fistula in CD.
The study will enroll at least 20 patients who will receive a single dose of darvadstrocel.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is 52 weeks.
Participants will make multiple visits to the clinic. In unavoidable circumstances, such as the coronavirus disease 2019 pandemic, exceptions may be granted for alternative methods for conducting participant visits with approval by the medical monitor and/or sponsor.
- Conditions
- Crohn's Disease, Complex Perianal Fistula
- Being tested
- Darvadstrocel
- Keywords
- Drug therapy.
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarvadstrocelBiological
Also called Cx601
Darvadstrocel perilesional injection.
| Study group | Role | What they receive |
|---|---|---|
| Darvadstrocel | Experimental | Participants were administered darvadstrocel (Cx601), 24 milliliters (mL) suspension of 120 million cells as a perilesional injection, once on Day 0. Receives: Biological: Darvadstrocel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved Combined Remission
Combined remission was defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of abscess(es) >2 centimeters (cm) (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by central magnetic resonance imaging (MRI) assessment.
Measured: Week 24
Secondary outcomes (10)
Percentage of Participants Who Achieved Clinical Remission
Clinical remission was defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression.
Measured: Weeks 24 and 52
Percentage of Participants Who Achieved Clinical Response
Clinical response was defined as closure of at least 50% of all treated external openings that were draining at baseline despite gentle finger compression.
Measured: Weeks 24 and 52
Time to Clinical Remission
Time to Clinical Remission was defined as the time in weeks from treatment start to first visit at which clinical remission was observed before Week 52; where clinical remission is said to have occurred if a clinical assessment showed closure of all treated external openings that were draining at baseline despite gentle finger compression. Participants without documented time to clinical remission by the end of study (Week 52), were censored at the date of last assessment along with the participants who discontinued without clinical remission before Week 52 at the date of last visit.
Measured: Up to Week 52
Time to Clinical Response
Time to clinical response defined as the time in weeks from treatment start to first visit at which clinical response was observed before Week 52; where clinical response is said to have occurred if a clinical assessment showed closure of at least 50% of all treated external openings that were draining at baseline despite gentle finger compression. Participants without documented time to clinical response by the end of study (Week 52), were censored at the date of last assessment along with the participants who discontinued without clinical response before Week 52 at the date of last visit.
Measured: Up to Week 52
Percentage of Participants With Relapse in Participants With Combined Remission at Week 24
Relapse was defined as reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed in participants who were in combined remission at Week 24.
Measured: From Week 24 to Week 52
Percentage of Participants With At Least One Treatment-Emergent Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent AE is an AE which occurs after exposure to study treatment.
Measured: Up to Week 52
Percentage of Participants With At Least One Treatment-Emergent Serious Adverse Event (SAE)
An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent SAE is an SAE which occurs after exposure to study treatment.
Measured: Up to Week 52
Percentage of Participants With At Least One Treatment-Emergent Adverse Event of Special Interest (AESI)
AESIs include immunogenicity/alloimmune reactions, hypersensitivity reactions, ectopic tissue formation, medication errors, tumorigenicity, and transmission of infectious agents. A treatment-emergent AESI is an AESI which occurs after exposure to study treatment.
Measured: Up to Week 52
Percentage of Participants With Potentially Clinically Significant Vital Sign Values
Vital signs include body temperature (oral measurement), blood pressure (systolic and diastolic, resting more than 5 minutes), and heart rate (beats per minute).
Measured: Up to Week 52
Percentage of Participants With Potentially Clinically Significant Laboratory Values
Laboratory parameters include hematology, biochemistry, and urinalysis.
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start30 Jun 2021
- Primary completion7 May 2025
- Study completion7 May 2025
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc.
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701411
- Sponsor's protocol ID
- Darvadstrocel-3004
- Other IDs
- 2020-003193-48, EMEA-001561-PIP01-13-M02, 2023-503973-39-00, jRCT2033200314, 2023
- Status last verified
- Nov 2025
- First submitted
- 6 Jan 2021
- Last updated
- 13 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be reidentified (due to the limited number of study participants/study sites.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Subjects With Crohn's Disease Over a Period of 24 Weeks and an Extended Follow-up Period for a Total of up to 52 Weeks
- ClinicalTrials.gov ID
- NCT04701411
- Acronym / sponsor ID
- Darvadstrocel-3004
- Conditions
- Crohn's Disease, Complex Perianal Fistula
- Keywords
- Drug therapy.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 7 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc.
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Posted 6 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A perianal fistula is an abnormal passageway that develops between the rectum and the skin near the anus. The fistula is considered complex if it branches into several openings or an abscess is also present.
The main aim of this study is to learn if complex perianal fistulas in children and teenagers close after treatment with darvadstrocel.
2 to 3 weeks before treatment with darvadstrocel, each participant will have surgery to clean the fistula and to drain any abscesses. On the day of treatment, each participant will have the fistula cleaned and will receive an injection of darvadstrocel near the fistula, under anesthetic.
For up to 1 year after treatment, participants will regularly visit the clinic for follow-up. The fistula will be examined and any side effects from the treatment will be recorded. Participants will have an MRI at one clinic visit (about 24 weeks after treatment).
Detailed description
The drug being tested in this study is called darvadstrocel (Cx601, cell suspension containing 120 million cells of allogeneic expanded adipose-derived mesenchymal stem cells [eASCs]). Darvadstrocel is being tested to treat complex perianal fistula in pediatric participants who have Crohn's disease (CD). This study will look at the safety and efficacy of darvadstrocel in the treatment of complex perianal fistula in CD.
The study will enroll at least 20 patients who will receive a single dose of darvadstrocel.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is 52 weeks.
Participants will make multiple visits to the clinic. In unavoidable circumstances, such as the coronavirus disease 2019 pandemic, exceptions may be granted for alternative methods for conducting participant visits with approval by the medical monitor and/or sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Darvadstrocel | Experimental | Biological: DarvadstrocelParticipants were administered darvadstrocel (Cx601), 24 milliliters (mL) suspension of 120 million cells as a perilesional injection, once on Day 0. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Has a CD diagnosis based on accepted clinical, endoscopic, histological and/or radiologic criteria at least 6 months before the screening visit.
- Has complex perianal fistula refractory to at least one of the following treatments: immunosuppressants or biologics (anti-TNFs, anti-integrin, anti-interleukin [IL] 12/23). Fistula(s) refractory to therapy is defined in this study as follows: Immunosuppressants: Inadequate response after 3 months, based on clinical assessment, or more treatment with azathioprine, 6-mercaptopurine or methotrexate. Biologics: Inadequate response after 14 weeks (16 weeks for anti-IL 12/23), based on clinical assessment, or more standard treatment for induction and maintenance.
- A complex perianal fistula(s) that meets one or more of the following criteria, modified from the American Gastroenterological Association (AGA) technical review: High intersphincteric, transsphincteric, extrasphincteric, or suprasphincteric as assessed by MRI. Presence of 2 or 3 external openings (tracts) as assessed by clinical examination. Associated fluid (abscess) collections as determined by MRI.
- This study requires that the participant has complex perianal fistulas with a maximum of 2 internal openings and a maximum of 3 external openings, based on clinical assessment. Darvadstrocel treatment is targeted for fistulas that connect between internal and external openings. A central reading of a locally performed pelvic MRI will be performed to confirm the location of the fistula and potential associated perianal abscess(es). Fistulas must have been draining for at least 6 weeks before the screening visit. Participants with actively draining simple subcutaneous fistulas, at the time of the screening visit, are not allowed in this study.
- Has inactive or mildly active luminal CD defined by meeting all of the following criteria:
Key exclusion criteria (20 listed)
- Has received any investigational compound within 12 weeks/84 days before screening.
- Has received darvadstrocel/eASC in a previous clinical study or as a therapeutic agent.
- The participant weighs <10 kg at screening.
- Has concomitant perianal fistula(s) with only internal or external opening(s).
- Has concomitant internal fistula(s) such as ileo-vesical, rectovaginal or ileo-colonic fistula(s).
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: Cx601Darvadstrocel perilesional injection. | Biological | Darvadstrocel |
Primary outcome
Percentage of Participants Who Achieved Combined Remission
Time frame: Week 24
Combined remission was defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of abscess(es) >2 centimeters (cm) (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by central magnetic resonance imaging (MRI) assessment.
10 secondary outcomes
Percentage of Participants Who Achieved Clinical Remission
Time frame: Weeks 24 and 52
Percentage of Participants Who Achieved Clinical Response
Time frame: Weeks 24 and 52
Time to Clinical Remission
Time frame: Up to Week 52
Time to Clinical Response
Time frame: Up to Week 52
Percentage of Participants With Relapse in Participants With Combined Remission at Week 24
Time frame: From Week 24 to Week 52
Percentage of Participants With At Least One Treatment-Emergent Adverse Event (AE)
Time frame: Up to Week 52
Percentage of Participants With At Least One Treatment-Emergent Serious Adverse Event (SAE)
Time frame: Up to Week 52
Percentage of Participants With At Least One Treatment-Emergent Adverse Event of Special Interest (AESI)
Time frame: Up to Week 52
Percentage of Participants With Potentially Clinically Significant Vital Sign Values
Time frame: Up to Week 52
Percentage of Participants With Potentially Clinically Significant Laboratory Values
Time frame: Up to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: No. De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be reidentified (due to the limited number of study participants/study sites.
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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.
Medical Director study director
Takeda
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Darvadstrocel in people with Crohn's Disease and Complex Perianal Fistula, run by Takeda at 22 sites in 5 countries.
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 8 inclusion and 20 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: stopped early, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Spain, Israel, Japan, Netherlands, Poland. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Achieved Combined Remission (time frame: Week 24). 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 13 Nov 2025.