Crohn DiseaseATTICNCT05594862
Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue.
A study testing Lipogems in people with Crohn Disease, run by Lipogems International spa at 1 site in Italy.
Trial summary
multicentre randomized controlled prospective study aimed at evaluating the efficacy of the infiltration of microfractured adipose tissue in the healing of perianal fistulas not-responding to treatment with biologics, in order to improve the quality of life and significantly reduce the risk of definitive ostomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Lipogems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jan 2023to 9 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- The patient's age is over 18 at the time of surgery.
- The patient suffers from Crohn's disease confirmed by instrumental and histological methods.
- The patient presents with complex perianal fistulising disease refractory to standard treatment (combination of surgical drainage of sepsis and local / systemic administration of anti-TNF-α for at least 1 year)
- The patient received, understood and signed informed consent for active participation in the study.
- The patient is able to understand the conditions of the study and to participate throughout the duration.
Who cannot join
- Patients with more than 1 internal and 3 external openings.
- Patients with ileus / colo ostomy.
- Patients with anus / rectum-vaginal fistulas.
- Patients with active HIV infections, hepatitis C (HCV), hepatitis B (HBV), tuberculosis.
- Patients with abdominal localization of Crohn's disease who may require general surgery during the study.
- Patients with active oncological or lymphoproliferative diseases from which it was not possible to safely withdraw an adequate quantity of lipoaspirate (at least 60 cc).
- Patients with clinical conditions that may compromise the success of the surgery or the follow-up.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue. Multicenter Randomized Controlled Prospective Study
multicentre randomized controlled prospective study aimed at evaluating the efficacy of the infiltration of microfractured adipose tissue in the healing of perianal fistulas not-responding to treatment with biologics, in order to improve the quality of life and significantly reduce the risk of definitive ostomy.
- Conditions
- Crohn Disease
- Being tested
- Lipogems
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipogemsDevice
Micro-fragmented adipose tissue infiltration
| Study group | Role | What they receive |
|---|---|---|
| Lipogems | Active comparator | surgical drainage with cone fistulectomy + infiltration of micro-fractured autologous adipose tissue at the level of the internal orifice Receives: Device: Lipogems |
| Placebo | No intervention | surgical drainage with cone fistulectomy + infiltration of physiological solution and suture point positioning at the internal orifice level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Combined remission
The primary outcome of the study will be the evaluation of the difference between the two experimental groups in terms of "combined remission" which will be defined at 24 weeks from surgery to clinical evaluation as "absence of drainage at a slight digital compression". of all treated external orifices that were draining at baseline and pelvic MRI as the absence of abscesses> 3 mm in correspondence of the treated perianal fistulas
Measured: 24 weeks
Secondary outcomes (1)
Number of participants with Clinical remission
Comparison between the two experimental groups in terms of clinical remission at 2 weeks (± 2 days), 4 weeks (± 2 days), 8 weeks (± 2 days), 12 weeks (± 3 days) and 24 weeks ± (5 days) from surgery (ie the closure of all external orifices treated that were draining at baseline despite a slight digital compression)
Measured: 2-4-8-12-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start9 Jan 2023
- Primary completion9 Apr 2025
- Study completion9 Jun 2026 (estimated)
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lipogems International spa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594862
- Sponsor's protocol ID
- ATTIC
- Acronym
- ATTIC
- Status last verified
- Mar 2026
- First submitted
- 13 Oct 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Crohn's Complex Perianal Fistulas With Tissue Transplantation by Local Injection of Micro-fragmented Autologous Adipose Tissue. Multicenter Randomized Controlled Prospective Study
- ClinicalTrials.gov ID
- NCT05594862
- Acronym / sponsor ID
- ATTIC / ATTIC
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lipogems International spaIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 9 Jun 2026 (estimated)
- First posted
- 26 Oct 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.
multicentre randomized controlled prospective study aimed at evaluating the efficacy of the infiltration of microfractured adipose tissue in the healing of perianal fistulas not-responding to treatment with biologics, in order to improve the quality of life and significantly reduce the risk of definitive ostomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipogems | Active comparator | Device: Lipogemssurgical drainage with cone fistulectomy + infiltration of micro-fractured autologous adipose tissue at the level of the internal orifice |
| Placebo | No intervention | –surgical drainage with cone fistulectomy + infiltration of physiological solution and suture point positioning at the internal orifice level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient's age is over 18 at the time of surgery.
- The patient suffers from Crohn's disease confirmed by instrumental and histological methods.
- The patient presents with complex perianal fistulising disease refractory to standard treatment (combination of surgical drainage of sepsis and local / systemic administration of anti-TNF-α for at least 1 year)
- The patient received, understood and signed informed consent for active participation in the study.
- The patient is able to understand the conditions of the study and to participate throughout the duration.
Key exclusion criteria (8 listed)
- Patients with more than 1 internal and 3 external openings.
- Patients with ileus / colo ostomy.
- Patients with anus / rectum-vaginal fistulas.
- Patients with active HIV infections, hepatitis C (HCV), hepatitis B (HBV), tuberculosis.
- Patients with abdominal localization of Crohn's disease who may require general surgery during the study.
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 |
|---|---|---|
| LipogemsMicro-fragmented adipose tissue infiltration | Device | Lipogems |
Primary outcome
Number of participants with Combined remission
Time frame: 24 weeks
The primary outcome of the study will be the evaluation of the difference between the two experimental groups in terms of "combined remission" which will be defined at 24 weeks from surgery to clinical evaluation as "absence of drainage at a slight digital compression". of all treated external orifices that were draining at baseline and pelvic MRI as the absence of abscesses> 3 mm in correspondence of the treated perianal fistulas
1 secondary outcome
Number of participants with Clinical remission
Time frame: 2-4-8-12-24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipogems in people with Crohn Disease, run by Lipogems International spa at 1 site in Italy.
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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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 Combined remission (time frame: 24 weeks). 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 27 Mar 2026.