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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.
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.
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.
B. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | CD 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 |
|
| placebo | Placebo Comparator | CD 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| local co-administration of autologous ADIpose | Combination 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. |
| Measure | Description | Time Frame |
|---|---|---|
| clinically evaluated | number of fistula closure | 24 weeks (w) |
| Magnetic resonance imaging (MRI) | confirmation of absence of collections > 2 cm of the treated perianal fistulas | weeks 24 |
| Magnetic resonance imaging (MRI) | confirmation of absence of collections > 2 cm of the treated perianal fistulas | weeks 52 |
| Measure | Description | Time Frame |
|---|---|---|
| a complete cessation of suppuration | weeks4, weeks12, weeks24, weeks52 | |
| closure of all the external openings | weeks4, weeks12 | |
| Index PDAI (Perianal Disease Activity ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JEAN CHARLES GRIMAUD, MD | Contact | +33491368739 | Jean-charles.GRIMAUD@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| EMILIE GARRIDO PRADALIE | APHM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Des Hopitaux de Marseille | Recruiting | Marseille | PACA | 13354 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35139888 | Derived | 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. |
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| placebo | Other | 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 |
|
| weeks4, weeks12, weeks24 and weeks52 |
| improvement of Quality of Life Short Inflammatory Bowel Disease Questionnaire (SIBDQ) (QoL) | weeks4, weeks12, weeks24 and weeks52 |
| Crohn's Disease Activity Index (CDAI) | weeks4, weeks12, weeks24 and weeks52 |
| Reduction of anal incontinence severity (Wexner score) | weeks4, weeks12, weeks24 and weeks52 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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