Crohn DiseasePhase 1/2NCT02520843
An Innovative Treatment for Fistula-in-ano in Crohn Disease : Local Micro Reinjection of Autologous Fat and SVF
A Phase 1/2 study testing stromal vascular fraction (SVF) in people with Crohn Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Crohn's disease is a chronic inflammation of all or part of the digestive tract, " from the mouth to the anus ". . Cell therapy is a new and promising approach for the treatment of inflammatory disease including Crohn's disease and fistulas. Adipose tissue seems to be an ideal source for cell therapy. 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?
- stromal vascular fraction (SVF)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Feb 2018
- Phase
- Phase 1/2
- 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
- Disease of Crohn diagnosed for at least 6 months according to the recognized clinical, endoscopic and histological criteria
- Presence of fistulas died anal complex estimated by clinical examination and MRI. A fistula died anal complex is, by definition, a fistula which answers at least one of the following criteria during its evolution: (1) high, trans-sphincter, extra-sphincter or above sphincter Inter-sphincter. (2) Presence of = 2 external openings. (3) Purulent Collections associated
- Active or slightly active Crohn luminal, defined by a CDAI (Crohn's Disease Activity Index) = 220
Who cannot join
- Disease of Crohn activates mainly luminal with a CDAI = 220 requiring an immediate treatment
- Patients having never received specific treatments of the anal died disease of Crohn with fistula, including by antibiotics
- Presence of an abscess or collections of more than 2 cms unless this problem is solved during the period of preparation
- Rectal and/or anal Stenosis and/or active proctitis, if it means a limitation of the surgical procedure
- Patient having undergone an operation of the fistula other than the drainage
- Patients under corticoids or by having receiving in the previous four weeks
- Active Malignant Tumors or history of Malignant tumors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Innovative Treatment for Fistula-in-ano in Crohn Disease : Local Micro Reinjection of Autologous Fat and Stromal Vascular Fraction
Crohn's disease is a chronic inflammation of all or part of the digestive tract, " from the mouth to the anus ". .
Cell therapy is a new and promising approach for the treatment of inflammatory disease including Crohn's disease and fistulas.
Read more
Adipose tissue seems to be an ideal source for cell therapy. This is a prospective, open, non-comparative, single center, phase I-II clinical trial. It will involve 10 patients and will be conducted over a period of 28 month.
This protocol is designed to evaluate, in patients with Crohn's disease and fistula-in-ano refractory to conventional medical and surgical treatment, the safety and efficacy of local microinjection of autologous adipose tissue and SVF from microaspirate .
The main objective is to assess tolerance and security. The secondary objective is to evaluate the effectiveness of this technique
Read the detailed description
Crohn's disease is a chronic inflammation of all or part of the digestive tract, " from the mouth to the anus ". Anoperineal lesions are a very frequent entity in this disease (20 to 80%) and a real therapeutic challenge. Among these lesions, we were interested in fistula-in-ano that are currently difficult to treat despite a large therapeutic arsenal.
Cell therapy is a new and promising approach for the treatment of inflammatory disease including Crohn's disease and fistulas.
Indeed, stem cells have shown some efficacy in several indications through their differentiation potential, including fistula-in-ano in Crohn's disease.
Adipose tissue seems to be an ideal source for cell therapy This is a prospective, open, non-comparative, single center, phase I-II clinical trial. It will involve 10 patients and will be conducted over a period of 28 month.
This protocol is designed to evaluate, in patients with Crohn's disease and fistula-in-ano refractory to conventional medical and surgical treatment, the safety and efficacy of local microinjection of autologous adipose tissue and SVF from microaspirate.
The main objective is to assess tolerance and security. The secondary objective is to evaluate the effectiveness of this technique Microaspiration is performed by a plastic surgeon under general anesthesia. He performs two types of fat removal : a sample of 120 cc wich is sent to the laboratory of cell therapy to obtain the SVF (5 cc) and a sample of 30 cc.
Once treatment obtained (SVF + adipose tissue) it is administered to the patient by local mico reinjection into (SVF) and around (adipose tissue) of the fistula. This administration is made by the surgeon under a second general anesthesia after viewing the fistula and removal of setons.
Then the patient is monitored with regular consultations at weeks 1, 2, 8, 16 et 48 and paraclinical (blood sample and magnetic resonance imaging of the perineum) at weeks 8 and 48 to evaluate tolerance and effectiveness of treatment.
At the end of the study, results that are expected are effectiveness of local micro reinjection of autologous adipose tissue and SVF for the treatment of refractory fistula-in-ano in Crohn's disease.
- Conditions
- Crohn Disease
- Being tested
- stromal vascular fraction (SVF)
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stromal vascular fraction (SVF)Drug
stromal vascular fraction (SVF) is administered to the patient suffering of Refractory Crohn's disease around of the fistula by local mico injection
| Study group | Role | What they receive |
|---|---|---|
| Crohn's disease treated by SVF | Experimental | Patients with Crohn's disease and fistula-in-ano refractory to conventional medical and surgical treatment, treated by Stromal Vascular Fraction ( SVF) reinjection Receives: Drug: stromal vascular fraction (SVF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy (measured as an absence of purulent collections superior to 2 cms concerning the fistula measured clinically and by MRI)
the patient is monitored with regular consultations at weeks 1, 2, 8, 16 et 48 and paraclinical (blood sample (hemogram , coagulation factors) and magnetic resonance imaging of the perineum) at weeks 8 and 48 to evaluate effectiveness of treatment. The efficacy of treatment is measured as an absence of purulent collections superior to 2 cms concerning the fistula treated at 12 and 48 weeks measured clinically and by MRI
Measured: 48 weeks
safety (measured by an absence of fever and local inflammatories symptoms)
the patient is monitored with regular consultations at weeks 1, 2, 8, 16 et 48 and paraclinical (blood sample (hemogram and coagulation factors) and magnetic resonance imaging of the perineum) at weeks 8 and 48 to evaluate tolerance of treatment. The safety is measured by an absence of fever and local inflammatories symptoms measured at week 1, 2,8, 16 and 48
Measured: 48 weeks
Secondary outcomes (1)
improvement of quality of life (assessed by questionnaire)
Quality of life is assessed by questionnaire concerning (Inflammatory Bowel Disease) (SIBDQ: Short Inflammatory Bowel Disease Questionnaire) at week 2, 12, 16 et 48
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionFeb 2018
- Study completionFeb 2018
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 DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Charles GRIMAUD, MD, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520843
- Sponsor's protocol ID
- 2013-002602-31
- Status last verified
- Jan 2019
- First submitted
- 5 Aug 2015
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Philandrianos C, Serrero M, Grimaud F, Magalon J, Visee C, Velier M, Francois P, Orsoni P, Magalon G, Grimaud JC, Desjeux A, Veran J, Sabatier F. First clinical case report of local microinjection of autologous fat and adipose-derived stromal vascular fraction for perianal fistula in Crohn's disease. Stem Cell Res Ther. 2018 Jan 10;9(1):4. doi: 10.1186/s13287-017-0736-6.
PubMed 29321063
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Treatment for Fistula-in-ano in Crohn Disease : Local Micro Reinjection of Autologous Fat and Stromal Vascular Fraction
- ClinicalTrials.gov ID
- NCT02520843
- Acronym / sponsor ID
- 2013-002602-31
- Conditions
- Crohn Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 13 Aug 2015 (estimated)
- 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.
Crohn's disease is a chronic inflammation of all or part of the digestive tract, " from the mouth to the anus ". .
Cell therapy is a new and promising approach for the treatment of inflammatory disease including Crohn's disease and fistulas.
Adipose tissue seems to be an ideal source for cell therapy. This is a prospective, open, non-comparative, single center, phase I-II clinical trial. It will involve 10 patients and will be conducted over a period of 28 month.
This protocol is designed to evaluate, in patients with Crohn's disease and fistula-in-ano refractory to conventional medical and surgical treatment, the safety and efficacy of local microinjection of autologous adipose tissue and SVF from microaspirate .
The main objective is to assess tolerance and security. The secondary objective is to evaluate the effectiveness of this technique
Detailed description
Crohn's disease is a chronic inflammation of all or part of the digestive tract, " from the mouth to the anus ". Anoperineal lesions are a very frequent entity in this disease (20 to 80%) and a real therapeutic challenge. Among these lesions, we were interested in fistula-in-ano that are currently difficult to treat despite a large therapeutic arsenal.
Cell therapy is a new and promising approach for the treatment of inflammatory disease including Crohn's disease and fistulas.
Indeed, stem cells have shown some efficacy in several indications through their differentiation potential, including fistula-in-ano in Crohn's disease.
Adipose tissue seems to be an ideal source for cell therapy This is a prospective, open, non-comparative, single center, phase I-II clinical trial. It will involve 10 patients and will be conducted over a period of 28 month.
This protocol is designed to evaluate, in patients with Crohn's disease and fistula-in-ano refractory to conventional medical and surgical treatment, the safety and efficacy of local microinjection of autologous adipose tissue and SVF from microaspirate.
The main objective is to assess tolerance and security. The secondary objective is to evaluate the effectiveness of this technique Microaspiration is performed by a plastic surgeon under general anesthesia. He performs two types of fat removal : a sample of 120 cc wich is sent to the laboratory of cell therapy to obtain the SVF (5 cc) and a sample of 30 cc.
Once treatment obtained (SVF + adipose tissue) it is administered to the patient by local mico reinjection into (SVF) and around (adipose tissue) of the fistula. This administration is made by the surgeon under a second general anesthesia after viewing the fistula and removal of setons.
Then the patient is monitored with regular consultations at weeks 1, 2, 8, 16 et 48 and paraclinical (blood sample and magnetic resonance imaging of the perineum) at weeks 8 and 48 to evaluate tolerance and effectiveness of treatment.
At the end of the study, results that are expected are effectiveness of local micro reinjection of autologous adipose tissue and SVF for the treatment of refractory fistula-in-ano in Crohn's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crohn's disease treated by SVF | Experimental | Drug: stromal vascular fraction (SVF)Patients with Crohn's disease and fistula-in-ano refractory to conventional medical and surgical treatment, treated by Stromal Vascular Fraction ( SVF) reinjection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Disease of Crohn diagnosed for at least 6 months according to the recognized clinical, endoscopic and histological criteria
- Presence of fistulas died anal complex estimated by clinical examination and MRI. A fistula died anal complex is, by definition, a fistula which answers at least one of the following criteria during its evolution: (1) high, trans-sphincter, extra-sphincter or above sphincter Inter-sphincter. (2) Presence of = 2 external openings. (3) Purulent Collections associated
- Active or slightly active Crohn luminal, defined by a CDAI (Crohn's Disease Activity Index) = 220
Key exclusion criteria (7 listed)
- Disease of Crohn activates mainly luminal with a CDAI = 220 requiring an immediate treatment
- Patients having never received specific treatments of the anal died disease of Crohn with fistula, including by antibiotics
- Presence of an abscess or collections of more than 2 cms unless this problem is solved during the period of preparation
- Rectal and/or anal Stenosis and/or active proctitis, if it means a limitation of the surgical procedure
- Patient having undergone an operation of the fistula other than the drainage
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 |
|---|---|---|
| stromal vascular fraction (SVF)stromal vascular fraction (SVF) is administered to the patient suffering of Refractory Crohn's disease around of the fistula by local mico injection | Drug | Crohn's disease treated by SVF |
Primary outcome
efficacy (measured as an absence of purulent collections superior to 2 cms concerning the fistula measured clinically and by MRI)
Time frame: 48 weeks
the patient is monitored with regular consultations at weeks 1, 2, 8, 16 et 48 and paraclinical (blood sample (hemogram , coagulation factors) and magnetic resonance imaging of the perineum) at weeks 8 and 48 to evaluate effectiveness of treatment. The efficacy of treatment is measured as an absence of purulent collections superior to 2 cms concerning the fistula treated at 12 and 48 weeks measured clinically and by MRI
safety (measured by an absence of fever and local inflammatories symptoms)
Time frame: 48 weeks
the patient is monitored with regular consultations at weeks 1, 2, 8, 16 et 48 and paraclinical (blood sample (hemogram and coagulation factors) and magnetic resonance imaging of the perineum) at weeks 8 and 48 to evaluate tolerance of treatment. The safety is measured by an absence of fever and local inflammatories symptoms measured at week 1, 2,8, 16 and 48
1 secondary outcome
improvement of quality of life (assessed by questionnaire)
Time frame: 48 weeks
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 17 Jan 2019.
- Derived from this study: PubMed 29321063Philandrianos C, Serrero M, Grimaud F, Magalon J, Visee C, Velier M, Francois P, Orsoni P, Magalon G, Grimaud JC, Desjeux A, Veran J, Sabatier F. First clinical case report of local microinjection of autologous fat and adipose-derived stromal vascular fraction for perianal fistula in Crohn's disease. Stem Cell Res Ther. 2018 Jan 10;9(1):4. doi: 10.1186/s13287-017-0736-6.
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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.
Jean-Charles GRIMAUD, MD principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing stromal vascular fraction (SVF) in people with Crohn Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 7 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 17 Jan 2019. 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 France. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
efficacy (measured as an absence of purulent collections superior to 2 cms concerning the fistula measured clinically and by MRI) (time frame: 48 weeks). The study lists 2 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 NCT02520843, 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 17 Jan 2019.