Clinical Trials Register

Summary
EudraCT Number:	2021-002043-30
Sponsor's Protocol Code Number:	2021-06
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2021-05-06
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2021-002043-30

A.3

Full title of the trial

NOVEL TREATMENT OF DIABETIC FOOT ULCER BY AUTOLOGOUS STROMAL VASCULAR FRACTION OF ADIPOSE TISSUE:
PHASE II OPEN-ENDED, MULTI-CENTRE STUDY

TRAITEMENT INNOVANT DE l’ULCERE DU PIED DIABETIQUE PAR FRACTION VASCULAIRE STROMALE AUTOLOGUE DU TISSU ADIPEUX :
ÉTUDE OUVERTE, MULTICENTRIQUE DE PHASE II

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

NOVEL TREATMENT OF DIABETIC FOOT ULCER BY AUTOLOGOUS STROMAL VASCULAR FRACTION OF ADIPOSE TISSUE

TRAITEMENT INNOVANT DE l’ULCERE DU PIED DIABETIQUE PAR FRACTION VASCULAIRE STROMALE AUTOLOGUE DU TISSU ADIPEUX :
ÉTUDE OUVERTE, MULTICENTRIQUE DE PHASE II

A.3.2

Name or abbreviated title of the trial where available

REGENDER

A.4.1

Sponsor's protocol code number

2021-06

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Assistance Publique Hôpitaux de Marseille
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	PHRCN -DGOS
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AP HM
B.5.2	Functional name of contact point	PROJECT MANAGER
B.5.3	Address:
B.5.3.1	Street Address	DRS 80 RUE BROCHIER
B.5.3.2	Town/ city	MARSEILLE
B.5.3.3	Post code	13354
B.5.3.4	Country	France
B.5.4	Telephone number	0491382747
B.5.5	Fax number	0491381479
B.5.6	E-mail	alexandra.giuliani@ap-hm.fr

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	FRACTION VASCULAIRE STROMALE AUTOLOGUE DU TISSU ADIPEUX
D.3.2	Product code	FVS
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	Autologous adipose tissue-derived stromal vascular fraction cells
D.3.9.4	EV Substance Code	SUB199808
D.3.10	Strength
D.3.10.1	Concentration unit	million organisms/ml million organisms/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Yes
D.3.11.3.1	Somatic cell therapy medicinal product	Yes
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	VIALEBEX 200 MG
D.2.1.1.2	Name of the Marketing Authorisation holder	LFB BIOMEDICAMENTS
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	VIALEBEX
D.3.2	Product code	SERUM ALBUMINE 5%
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ALBUMINE HUMAINE
D.3.9.2	Current sponsor code	sérum albumine humaine
D.3.9.3	Other descriptive name	HUMAN ALBUMIN AS MACROAGGREGATES
D.3.9.4	EV Substance Code	SUB23304
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	serum physiologique 0.9 %
D.2.1.1.2	Name of the Marketing Authorisation holder	BAXTER
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	chlorure de sodium
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Sodium chloride
D.3.9.2	Current sponsor code	CHLORURE DE SODIUM
D.3.9.4	EV Substance Code	SUB12581MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.9
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	ALBUNORM 20%, 200 g/l, solution pour perfusion
D.2.1.1.2	Name of the Marketing Authorisation holder	OCTAPHARMA FRANCE
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	ALBUNORM
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

DIABETIC FOOT ULCER

ulcère du pied diabétique (UPD)

E.1.1.1

Medical condition in easily understood language

DIABETIC FOOT ULCER

ulcère du pied diabétique (UPD)

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The main objective of this study is to evaluate the effectiveness of local SVF injection in the treatment of UPD refractory to conventional well-conducted treatment (International Working group) in week 20.

L’objectif principal de cette étude est d’évaluer l’efficacité de l’injection locale de FVS dans le traitement de l’UPD réfractaire au traitement conventionnel bien conduit (International Working group) à la semaine 20.

E.2.2

Secondary objectives of the trial

Secondary objectives associated with treatment effectiveness are:
5) the time to complete wound healing (based on the wound overlay) from the FVS (J0) injection to the complete epidermis.
6) the regression/change in the area of the wound in absolute and relative values between the initial assessment and the end of treatment (S20) or premature cessation (based on the layer of the wound).

Les objectifs secondaires associés à l’efficacité du traitement sont :
5) le délai d’atteinte d’une cicatrisation complète de la plaie (sur la base du calque de la plaie) depuis l’injection de la FVS (J0) jusqu’à l’épidermisation complète.
6) la régression/évolution de la surface de la plaie en valeur absolue et en valeur relative entre l’évaluation initiale et la fin du traitement (S20) ou l’arrêt prématuré (sur la base du calque de la plaie).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Informed Consent Form Information and Signature
Female or male patient 18 years of age or older
Type 1 or 2 diabetes mellitus patient with 10% HbA1C less than 1 month old (if this result is not available at the inclusion visit, analysis should be done during the 15-day assessment period)
Affiliation to social security.
Patient can be followed by the same team of investigators throughout the study.
Patient willing to wear the discharge system daily and the prescribed dressing throughout the study.
Patient with BMI 18.5 Kg/m² (in order to have sufficient fat tissue)
Good overall condition, based on history and clinical examination
Women of reproductive age

 Information et signature du formulaire de consentement éclairé
 Patient de sexe féminin ou masculin âgé de 18 ans ou plus
 Patient atteint de diabète sucré de type 1 ou 2 avec un taux d'HbA1C <10% datant de moins de 1 mois (si ce résultat n’est pas disponible à la visite d’inclusion, l’analyse doit être faite pendant la période d’évaluation de 15 jours)
 Affiliation à la sécurité sociale.
 Patient pouvant être suivi par la même équipe d’investigateurs durant l’ensemble de l’étude.
 Patient disposé à porter le système de décharge chaque jour et le pansement prescrit durant l’ensemble de la durée de l’étude.
 Patient présentant un IMC ≥ 18,5 Kg/m² (afin d’avoir du tissu adipeux en quantité suffisante)
 Bon état général, selon l’anamnèse et l’examen clinique
 Les femmes en âge de procréer doivent présenter un test (sérique ou urinaire) de grossesse négatif (seuil de détection (sensibilité) : 25 mIU hCG/ml)). Les patients des deux sexes doivent utiliser une méthode de contraception fiable.

E.4

Principal exclusion criteria

Pregnant or nursing woman or woman of childbearing age without effective contraception,

Known hypersensitivity to human albumin.
Surgical revascularization or surgery of the lower limbs for less than a month,
Ischemic accident (stroke, myocardial infarction) within 3 months before inclusion
Patient with kidney failure requiring dialysis
Systemic infection not controlled by appropriate antibiotic treatment
Patient with documented osteomyelitis
Patient with active neoplasia, treated with radiotherapy, chemotherapy, hormone therapy or immunosuppressive therapy.
Patient treated for chronic pathology requiring high-dose corticosteroid therapy ( 40 mg/d prednisolone or equivalent)

 Femme enceinte ou allaitante ou femme en âge de procréer sans contraception efficace,

 Hypersensibilité connue à l’albumine humaine.
 Revascularisation chirurgicale ou chirurgie des membres inférieurs depuis moins de un mois,
 Accident ischémique (AVC, Infarctus du myocarde) dans les 3 mois avant inclusion
 Patient présentant une insuffisance rénale nécessitant une dialyse
 Infection systémique non contrôlée par un traitement antibiotique adapté
 Patient porteur d’une ostéomyélite documentée
 Patient présentant une néoplasie active, traitée par radiothérapie, chimiothérapie, hormonothérapie ou traitement immunosuppresseurs.
 Patient traité pour une pathologie chronique nécessitant la prise de corticothérapie à haute dose (≥ 40 mg/j de prednisolone ou équivalent)

E.5 End points

E.5.1

Primary end point(s)

the effectiveness of local SVF injection (% % of wounds completely healed by week 20 (S20) post-injection)

l’efficacité de l’injection locale de FVS (pourcentage (%) de plaies complètement cicatrisées à la semaine 20 (S20) post-injection)

E.5.1.1

Timepoint(s) of evaluation of this end point

20 WEEKS

20 semaines

E.5.2

Secondary end point(s)

time to complete wound healing

le délai d’atteinte d’une cicatrisation complète de la plaie

E.5.2.1

Timepoint(s) of evaluation of this end point

20WEEKS

20 semaines

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

none

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-01-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-06-09

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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