An Innovative Treatment for Fistula-in-ano in Crohn Disease : Local Micro Reinjection of Autologous Fat and SVF
1 other identifier
interventional
10
1 country
1
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2015
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedJanuary 17, 2019
January 1, 2019
2.3 years
August 5, 2015
January 16, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
48 weeks
Secondary Outcomes (1)
improvement of quality of life (assessed by questionnaire)
48 weeks
Study Arms (1)
Crohn's disease treated by SVF
EXPERIMENTALPatients with Crohn's disease and fistula-in-ano refractory to conventional medical and surgical treatment, treated by Stromal Vascular Fraction ( SVF) reinjection
Interventions
stromal vascular fraction (SVF) is administered to the patient suffering of Refractory Crohn's disease around of the fistula by local mico injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
Related Publications (1)
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.
PMID: 29321063DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Charles GRIMAUD, MD
Assistance Publique Hopitaux De Marseille
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2015
First Posted
August 13, 2015
Study Start
October 1, 2015
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
January 17, 2019
Record last verified: 2019-01