Anal FistulafistulaNCT03466515
Stem Cells Treatment of Complex Crohn's Anal Fistula
A study testing stem cells injection in people with Anal Fistula and Crohn Disease, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
A pilot study to investigate the safety and feasibility of stem cells treatment of complex anal fistula in patients with Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula, Crohn Disease
- What is being tested?
- stem cells injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2018to 31 Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- patients with Crohn's anal fistulas and> 18 yrs old.
Who cannot join
- Signs of suppuration around the fistula
- Active intestinal Crohn disease not in remission
- Malignancy within 5 years
- Previous radiotherapy of the abdomen and pelvis
- BMI under 18.5
- Coagulopathy
Show all 9Show fewer
- Fistula with side branches
- Low anal fistula
- Verified syphilis, HIV, or hepatitis on screening test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stem Cells Treatment of Complex Crohns Perianal Fistula. A Pilot Clinical Study
A pilot study to investigate the safety and feasibility of stem cells treatment of complex anal fistula in patients with Crohn's disease.
Read the detailed description
Stem cells therapy in the management of soft tissue healing has been shown to be safe and feasible with encouraging short-term results both for crypto glandular and Crohns anal fistula. The long-term results are still insufficient but based on only a few studies conducted with small patient series and various techniques and type of stem cells. In the present study the patient's own adipose tissue derived regenerative cells (ADRCs) will be used. Traditionally the stem cells are injected into the fistula tract; however survival and retaining the stem cells in the fistula tract is problematic. Alternatively, one may apply stem cells enriched fatty tissue around and into the fistula tract. The aim of this project is to develop a method for treatment of patients with Crohns fistula. The results of conventional surgery are disappointing and followed by a high degree of recurrence and complications.
- Conditions
- Anal Fistula, Crohn Disease
- Being tested
- stem cells injection
- Keywords
- stem cells therapy
- Medical subject headings
- Rectal Fistula, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stem cells injectionProcedure or surgery
Also called liposuction, fistula closure
two surgical interventions as day-surgery, starting with liposuction from the abdomen (about 200-300 ml), and fistula tract debridement and closure of internal opening. The external opening is excised. About 30-40 ml fresh harvested patients own fatty tissue are then injected with large needle around the fistula from internal til external opening.The resting harvested fatty tissue will be sent to stem cells (Adipose Derived Regenrative Cells ADRCs) isolation, using Cytori Celusion system®. When the stem cells isolation is completed, 4ml concentrated stem cells ( contains around 20-40 millions cells ) will be injected around the prepared fistula tract, the same site where the fresh harvested fatty tissue injected before.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Patients enrolled in the study will be treated for their anal fistula by surgical closure of the internal opening, debridement of the fistula and injection of patients own stem cells enriched fatty tissue around the fistula. Receives: Procedure: stem cells injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing
closure of the fistula with no secretions
Measured: 6 months
Secondary outcomes (5)
recurrence
recurrence of the fistula
Measured: 6 months
time to healing
time required to healing of the fistula
Measured: 6 months
major adverse effects
occurrence of infections, sepsis bleeding and allergy.
Measured: 6 months
radiological healing
Changes on MRI scanning
Measured: at 6 months
functional outcome
changes in Wexner incontinence score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start1 Jun 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pilot study with a maximum of 20 patients
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Karam Matlub Sørensen, University of Southern Denmark
- Investigators
- Karam Matlub, MD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466515
- Sponsor's protocol ID
- S-20170140
- Acronym
- fistula
- Status last verified
- Jan 2021
- First submitted
- 8 Mar 2018
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stem Cells Treatment of Complex Crohns Perianal Fistula. A Pilot Clinical Study
- ClinicalTrials.gov ID
- NCT03466515
- Acronym / sponsor ID
- fistula / S-20170140
- Conditions
- Anal Fistula, Crohn Disease
- Keywords
- stem cells therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 15 Mar 2018 (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.
A pilot study to investigate the safety and feasibility of stem cells treatment of complex anal fistula in patients with Crohn's disease.
Detailed description
Stem cells therapy in the management of soft tissue healing has been shown to be safe and feasible with encouraging short-term results both for crypto glandular and Crohns anal fistula. The long-term results are still insufficient but based on only a few studies conducted with small patient series and various techniques and type of stem cells. In the present study the patient's own adipose tissue derived regenerative cells (ADRCs) will be used. Traditionally the stem cells are injected into the fistula tract; however survival and retaining the stem cells in the fistula tract is problematic. Alternatively, one may apply stem cells enriched fatty tissue around and into the fistula tract. The aim of this project is to develop a method for treatment of patients with Crohns fistula. The results of conventional surgery are disappointing and followed by a high degree of recurrence and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pilot study with a maximum of 20 patients
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Procedure: stem cells injectionPatients enrolled in the study will be treated for their anal fistula by surgical closure of the internal opening, debridement of the fistula and injection of patients own stem cells enriched fatty tissue around the fistula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with Crohn's anal fistulas and> 18 yrs old.
Key exclusion criteria (9 listed)
- Signs of suppuration around the fistula
- Active intestinal Crohn disease not in remission
- Malignancy within 5 years
- Previous radiotherapy of the abdomen and pelvis
- BMI under 18.5
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 |
|---|---|---|
| stem cells injectionAlso: liposuction, fistula closuretwo surgical interventions as day-surgery, starting with liposuction from the abdomen (about 200-300 ml), and fistula tract debridement and closure of internal opening. The external opening is excised. About 30-40 ml fresh harvested patients own fatty tissue are then injected with large needle around the fistula from internal til external opening.The resting harvested fatty tissue will be sent to stem cells (Adipose Derived Regenrative Cells ADRCs) isolation, using Cytori Celusion system®. When the stem cells isolation is completed, 4ml concentrated stem cells ( contains around 20-40 millions cells ) will be injected around the prepared fistula tract, the same site where the fresh harvested fatty tissue injected before. | Procedure or surgery | intervention |
Primary outcome
healing
Time frame: 6 months
closure of the fistula with no secretions
5 secondary outcomes
recurrence
Time frame: 6 months
time to healing
Time frame: 6 months
major adverse effects
Time frame: 6 months
radiological healing
Time frame: at 6 months
functional outcome
Time frame: 6 months
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 1 Feb 2021.
- 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.
Karam Matlub, MD principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stem cells injection in people with Anal Fistula and Crohn Disease, run by University of Southern Denmark at 1 site in Denmark.
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 9 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 1 Feb 2021. 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 Denmark. 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?
healing (time frame: 6 months). 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 1 Feb 2021.