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Trial record 22 of 109 for:    stromal vascular fraction

An Innovative Treatment for Fistula-in-ano in Crohn Disease : Local Micro Reinjection of Autologous Fat and SVF

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ClinicalTrials.gov Identifier: NCT02520843
Recruitment Status : Completed
First Posted : August 13, 2015
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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


Condition or disease Intervention/treatment Phase
Crohn Disease Drug: stromal vascular fraction (SVF) Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Innovative Treatment for Fistula-in-ano in Crohn Disease : Local Micro Reinjection of Autologous Fat and Stromal Vascular Fraction
Study Start Date : October 2015
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Crohn's disease treated by SVF
Patients with Crohn's disease and fistula-in-ano refractory to conventional medical and surgical treatment, treated by Stromal Vascular Fraction ( SVF) reinjection
Drug: 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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. improvement of quality of life (assessed by questionnaire) [ Time Frame: 48 weeks ]
    Quality of life is assessed by questionnaire concerning (Inflammatory Bowel Disease) (SIBDQ: Short Inflammatory Bowel Disease Questionnaire) at week 2, 12, 16 et 48



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

- 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02520843


Locations
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France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Principal Investigator: Jean-Charles GRIMAUD, MD Assistance Publique Hopitaux De Marseille

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02520843     History of Changes
Other Study ID Numbers: 2013-002602-31
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Crohn Disease
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical