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Crohn DiseasePhase 2ADICROHN2NCT04010526

Evaluation of Local Co-administration of Autologous ADIpose Derived Stromal Vascular Fraction With Microfat for Refractory Perianal CROHN's Fistulas.

A Phase 2 study testing local co-administration of autologous ADIpose in people with Crohn Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Autologous ADSVF constitutes an innovative therapeutic strategy that concentrates various types of regenerative stem cells and paracrine factors able to promote angiogenesis and tissue repair. 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?
local co-administration of autologous ADIpose
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
1 siteFrance
Study dates
19 Feb 2020to Oct 2028
Phase
Phase 2
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

  • Signed informed consent
  • Patients with Crohn's Disease (CD) diagnosed at least 6 months earlier in accordance with accepted clinical, endoscopic, histological and/or radiologic criteria
  • Presence of refractory complex perianal fistulas assessed by clinical assessment during examination under anaesthesia (preparation treatment) and MRI.
  • Non-active or mildly active luminal CD defined by a CDAI ≤ 220
  • Patients of either sex aged 18 years or older
  • Good general state of health according to clinical history and a physical examination
  • For women of a childbearing age, they must have negative serum or urine pregnancy test (sensitive to 25 IU human chorionic gonadotropin [hCG]). Both men and women should use appropriate birth control methods defined by the investigator.

Who cannot join

  • Presence of dominant luminal active Crohn's disease requiring immediate therapy
  • CDAI > 220
  • Patient naïve to specific treatment for perianal fistulising Crohn's disease
  • Presence of an abscess or collections > 2 cm, unless resolved in the preparation procedure
  • Rectal and/or anal stenosis if this means a limitation for any surgical procedure
  • Patient with ongoing steroid treatment or treated with steroids in the last 4 weeks
Show all 15Show fewer
  • Malignant tumour or patients with a prior history of any malignant tumour, including any type of fistula carcinoma
  • Current or recent history of abnormal, severe, progressive, uncontrolled infectious, hepatic, haematological, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral disease
  • Congenital or acquired immunodeficiencies
  • Contraindication to local anaesthetics or gadolinium (MRI contrast)
  • Contraindication to MRI scan, (e.g., due to the presence of pacemakers, hip replacements or severe claustrophobia)
  • Pregnant or breastfeeding women
  • Contraindication to the anaesthetic or surgical procedure
  • BMI < 18 to insure adequate abdominal or other subcutaneous adipose tissue accessible by lipoharvest
  • Any active viral infection follows: HIV, HTLV I et II, VHB, VHC and Syphillis

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

JEAN CHARLES GRIMAUD, MD contact

+33491368739

Jean-charles.GRIMAUD@ap-hm.fr

France1 site, 1 recruiting

  • Assistance Publique Des Hopitaux de Marseille

    Marseille, PACA, 13354

    JEAN CHARLES GRIMAUD, MD, +33491368739, Jean-charles.GRIMAUD@ap-hm.fr

    Recruiting

Other trials in France

About this study

Official title: Double-blind Randomised Placebo Controlled Study Evaluating Local Co-administration of Autologous ADIpose Derived Stromal Vascular Fraction With Microfat for Refractory Perianal CROHN's Fistulas.

Autologous ADSVF constitutes an innovative therapeutic strategy that concentrates various types of regenerative stem cells and paracrine factors able to promote angiogenesis and tissue repair. Together with the ease of collection from a minimally manipulated lipoaspirate, the unique properties of ADSVF offer new opportunities for fistulas' healing in patients with CD. The use of ADSVF is currently developed in many clinical fields based on safety and efficacy data.

Our ADICROHN pilot study evaluating safety and tolerance of local administration of autologous ADSVF with microfat in CD patients with complex perianal fistula refractory to conventional medical and surgical therapy showed that this novel therapeutic approach appears feasible and safe.

Read more

However the therapeutic potential of local this combined treatment in healing refractory perianal Crohn's fistulas still remains to be demonstrated.

The main objective of this study is to assess the efficacy of local injection of autologous ADSVF and microfat versus placebo for the treatment of complex refractory perianal Crohn's fistulas at week 24.

The efficacy will be assessed on clinical assessment of closure of all the external openings that were drained at baseline, and MRI confirmation of absence of collections > 2 cm of the treated perianal fistulas at week 24.

Read the detailed description

Autologous ADSVF constitutes an innovative therapeutic strategy that concentrates various types of regenerative stem cells and paracrine factors able to promote angiogenesis and tissue repair. Together with the ease of collection from a minimally manipulated lipoaspirate, the unique properties of ADSVF offer new opportunities for fistulas' healing in patients with CD. The use of ADSVF is currently developed in many clinical fields based on safety and efficacy data.

Our ADICROHN pilot study evaluating safety and tolerance of local administration of autologous ADSVF with microfat in CD patients with complex perianal fistula refractory to conventional medical and surgical therapy showed that this novel therapeutic approach appears feasible and safe.

However the therapeutic potential of local this combined treatment in healing refractory perianal Crohn's fistulas still remains to be demonstrated.

  1. Primary objective/endpoint The main objective of this study is to assess the efficacy of local injection of autologous ADSVF and microfat versus placebo for the treatment of complex refractory perianal Crohn's fistulas at week 24 (W24), The efficacy will be assessed on clinical assessment of closure (despite gentle finger compression) of all the external openings that were drained at baseline, and MRI confirmation of absence of collections > 2 cm of the treated perianal fistulas at week 24.
Conditions
Crohn Disease
Being tested
local co-administration of autologous ADIpose, placebo
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • local co-administration of autologous ADIposeCombination product

    local co-administration of autologous ADIpose derived stromal vascular fraction and microfat for refractory perianal CROHN's fistulas Each batch of the final product is composed of one 5 mL syringes containing 25,9 +/- 10,7 millions viable cells. Each syringe will be obstructed with a sterile stopper and packaged in an external packaging.

  • placeboOther

    local co-administration of placebo The study placebo will consist of a saline solution for intralesional administration and will follow the same administration schema described for the SFV

Study groups in NCT04010526
Study groupRoleWhat they receive
treatmentExperimentalCD patients with complex refractory perianal fistula refractory to conventional medical and surgical therapy referred to the gastroenterology departments of the 3 centers in charge of treatment local co-administration of autologous ADIpose will be performed
Receives: Combination Product: local co-administration of autologous ADIpose
placeboPlacebo comparatorCD patients with complex refractory perianal fistula refractory to conventional medical and surgical therapy referred to the gastroenterology departments of the 3 centers in charge of treatment local co-administration of placebo will be performed
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. clinically evaluated

    number of fistula closure

    Measured: 24 weeks (w)

  2. Magnetic resonance imaging (MRI)

    confirmation of absence of collections > 2 cm of the treated perianal fistulas

    Measured: weeks 24

  3. Magnetic resonance imaging (MRI)

    confirmation of absence of collections > 2 cm of the treated perianal fistulas

    Measured: weeks 52

Secondary outcomes (6)

  1. a complete cessation of suppuration

    Measured: weeks4, weeks12, weeks24, weeks52

  2. closure of all the external openings

    Measured: weeks4, weeks12

  3. Index PDAI (Perianal Disease Activity )

    Measured: weeks4, weeks12, weeks24 and weeks52

  4. improvement of Quality of Life Short Inflammatory Bowel Disease Questionnaire (SIBDQ) (QoL)

    Measured: weeks4, weeks12, weeks24 and weeks52

  5. Crohn's Disease Activity Index (CDAI)

    Measured: weeks4, weeks12, weeks24 and weeks52

  6. Reduction of anal incontinence severity (Wexner score)

    Measured: weeks4, weeks12, weeks24 and weeks52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2019
  2. Study start19 Feb 2020
  3. Primary completionJul 2028 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

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 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04010526
Sponsor's protocol ID
RCAPHM18_0013
Acronym
ADICROHN2
Status last verified
Sep 2024
First submitted
6 Sep 2018
Last updated
1 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Guillo L, Grimaud F, Houser F, Prost C, Jouve E, Philandrianos C, Abellan M, Veran J, Visee C, Beyer-Berjot L, Desjeux A, Dignat-George F, Leone M, Grimaud JC, Sabatier F, Serrero M, Magalon J. Three-year outcome of local injection of autologous stromal vascular fraction cells and microfat in refractory perianal fistulas of Crohn's disease. Stem Cell Res Ther. 2022 Feb 9;13(1):67. doi: 10.1186/s13287-022-02738-x.

    PubMed 35139888

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing local co-administration of autologous ADIpose 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 7 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 1 Oct 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

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?

Contact JEAN CHARLES GRIMAUD, MD (+33491368739, Jean-charles.GRIMAUD@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinically evaluated (time frame: 24 weeks (w)). The study lists 3 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 NCT04010526, 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 1 Oct 2024.

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