Clinical Trials Register

Summary
EudraCT Number:	2016-004110-10
Sponsor's Protocol Code Number:	2ABC
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-05-12
Trial results	View 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

Poland - Office for Medicinal Products

A.2

EudraCT number

2016-004110-10

A.3

Full title of the trial

Evaluation the safety and efficacy of the treatment of scars and cutis laxa syndrome with the use of autologous (fresh and stored) stem cells isolated from adipose tissue within the project: 'The therapeutic potential of mesenchymal stem cells tested in clinical trials and in vitro - a justification for characterized cells storage'.

Ocena bezpieczeństwa i skuteczności leczenia blizn i uszkodzenia sprężystego skóry z zastosowaniem autologicznych świeżych i bankowanych komórek macierzystych, izolowanych z tkanki tłuszczowej w ramach projektu 'Potencjał terapeutyczny mezenchymalnych komórek macierzystych testowany w próbach klinicznych oraz in vitro - uzasadnienie dla bankowania scharakteryzowanych komórek'.

A.3.1

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

A.4.1

Sponsor's protocol code number

2ABC

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	Medical University of Warsaw
B.1.3.4	Country	Poland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	The National Centre for Research and Development
B.4.2	Country	Poland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Timeless Chirurgia Plastyczna
B.5.2	Functional name of contact point	Janusz Jaworowski PI
B.5.3	Address:
B.5.3.1	Street Address	Abrahama 18/322
B.5.3.2	Town/ city	Warsaw
B.5.3.3	Post code	03-982
B.5.3.4	Country	Poland
B.5.4	Telephone number	0048508713484
B.5.6	E-mail	biuro@timeless.com.pl

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	Autologous stromal vascular fraction for scars and cutis laxa syndrome treatment.
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	Intradermal use 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)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Yes
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	Yes
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	Yes
D.3.11.3.5.1	CAT classification and reference number	Ref. EMA/CAT/555895/2016 Ref. EMA/CAT/452302/2016 - corr
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	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	Autologous adipose derived mesenchymal stem cells for scars and cutis laxa syndrome treatment.
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	Intradermal use 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)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Yes
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	Yes
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	Yes
D.3.11.3.5.1	CAT classification and reference number	Ref. EMA/CAT/555895/2016 Ref. EMA/CAT/452302/2016 - corr
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Scar or cutis laxa

Blizna lub zmiana zanikowa skory grzbietu rak

E.1.1.1

Medical condition in easily understood language

Scar or age-related changes of dorsal hands' skin.

Blizna lub zmieniona z wiekiem skora grzbietu rak

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10039581
E.1.2	Term	Scar conditions and fibrosis of skin
E.1.2	System Organ Class	100000004863

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10011692
E.1.2	Term	Cutis laxa
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue disorders

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 purpose of this clinical research is to evaluate the safety and efficacy of therapy using fresh and stored autologous stem cells isolated from adipose tissue injected in patients with scars or cutis laxa syndrome.

Celem niniejszego badania klinicznego jest wykazanie bezpieczeństwa i skuteczności terapii autologicznymi świeżymi i bankowanymi komórkami macierzystymi pochodzącymi z tkanki tłuszczowej dostarczanymi za pośrednictwem iniekcji miejscowej u pacjentów z bliznami lub objawami uszkodzenia sprężystego skóry grzbietowej powierzchni rąk.

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Age 18 - 75 years at the time of qualification to the study
2.Signing informed consent form
3.Women / men
4.Scar or cutis laxa
a.Scar eligibility conditions:
•Area:
•Stomach
•Limbs
•Face
•Back
•Chest and neck
•Onset time: over 6 months
•Scars previously untreated
•Atrophic and hypertrophic scars
•Two scars in close location, each from 2 to 6 cm long and a total surface area of 1 sq. cm to 5 sq. cm or single scar of 8 to 16 cm long and a surface area of 1 to 5 sq.cm or a selected fragment of a scar of a surface area of 1 to 5 sq.cm in case of a scar's surface area bigger than 5 sq.cm.
•Etiology
•traumatic
•burns
•surgical
b.Cutis laxa eligibility conditions:
•Vast sun discoloration.
•Pigmentation changes areas.
•Solar stains.
•Pigment changes also called age spots.
•Erythema.
•Cracked blood vessels.
•Ruby nevus.
•Atrophic changes of the skin and subcutaneous tissue
•Changes symmetrically present on both hands
5.Without previous aesthetic treatment in this area, previous standard care.
6.Patient's health which allows anesthesia for liposuction.
7.Ready for follow-up visits

1.Wiek 18 – 75 lat w momencie włączenia do badania.
2.Zgoda na uczestnictwo w badaniu, z podpisaniem formularza świadomej zgody na udział w badaniu klinicznym
3.Kobiety / mężczyźni
4.Blizna lub zmiana zanikowa skóry grzbietu rąk (cutis laxa)
a.Blizna warunki kwalifikujące:
•Okolica:
oBrzuch
oKończyny
oTwarz
oPlecy
oKlatka piersiowa i szyja
•Czas od powstania: powyżej 6 miesięcy
•Blizny dotychczas nie leczone
•Blizny zanikowe i przerostowe
Dwie blizny w zbliżonej lokalizacji, każda od 1 do 6 cm i łącznym polu powierzchni od 1 cm2 do 5 cm2 lub pojedyncza blizna długości 2 do 16 cm i polu powierzchni od 1 do 5 cm2 lub oznaczony fragment o polu powierzchni od 1 cm2 do 5 cm2 w przypadku blizny o polu powierzchni większym niż 5 cm2.
•Etiologia
oPourazowe
oPooparzeniowe
oChirurgiczne
b.Zmiany zanikowe skóry grzbietu rąk (cutis laxa) warunki kwalifikujące:
•Rozległe przebarwienia słoneczne.
•Obszary zmian pigmentowych
•Plamy posłoneczne
•Zmiany pigmentowe zwane również plamami starczymi.
•Rumień
•Popękane naczynka
•Znamiona rubinowe
•Zmiany zanikowe skóry i tkanki podskórnej
•Zmiany symetrycznie obecne na obu dłoniach
5.Bez wcześniejszych zabiegów estetycznych w tej okolicy, wcześniej standardowa pielęgnacja.
6.Stan zdrowia pacjenta, który pozwala na przeprowadzenie znieczulenia do liposukcji
7.Gotowość pacjenta do zgłaszania się na wizyty kontrolne

E.4

Principal exclusion criteria

1.Active cancer (diagnosed during past 5 years), excluding cured non-melanoma skin cancer or other non-invasive or in situ cancer (eg. cervical cancer)
2.Active chronic infection
3. Chronic use of NSAIDs
4.Taking any anticoagulant by the patient during 1 hour prior to surgery (excluding prophylactic heparin before liposuction).
5.Coagulation disorders in medical history and actual test results out of normal ranges.
6.Skin infections.
7.Allergies to medications used during liposuction (eg. Lidocaine and derivatives).
8.Status post radiotherapy or chemotherapy
9.Any other disease or condition that may change the evaluation of skin condition (eg. autoimmune disease of the connective tissue)
10.Taking the corticosteroid drugs or cytotoxic medications during the past 30 days
11.Allergy to materials of animal origin
12.Diagnosis of diabetes Type I
13.Diagnosis of AIDS, HBV or HCV (positive laboratory test result)
14.Hirsutism or a tattoo at the treatment site
15.Insufficient fat tissue for fat donation
16.Scar after removal of cancer.
17.The patient does not qualify to participate in this study in the opinion of the investigator
18.Pregnancy, breast feeding.
19.Photoallergy or using the drugs causing photoallergy.
20.Active herpes
21.Idiopathic keloids
22.Esthetic or medicinal treatments done previously at the treatment site
23.The use of derivatives of vitamin A during 6 months before the treatment
24.Fitzpatric phototype V and VI
25.Patients with mental disorders or addicted to drugs and/or alcohol.
26.Participation in other clinical study during the past 6 months.
27.Reactive result of serological and viral tests (ie. HIV-1 and 2 (HIV Ag / Ab)
•Hepatitis B Virus Infection, – HbsAg and Anti-HBc;
•Hepatitis C Virus Infection, Anti-HCV;
•Syphilis specific tests

1.Aktywny nowotwór (zdiagnozowany w ciągu 5 lat), z wyjątkiem wyleczonego non-melanoma raka skóry lub innego nieinwazyjnego lub in-situ nowotworu (np. raka szyjki macicy)
2.Aktywne zakażenie przewlekłe
3.Stosowanie NLPZ lub steroidów
4.Przyjecie przez pacjenta jakiegokolwiek antykoagulantu w ciągu 1 godziny przed zabiegiem (z wyłączeniem profilaktycznej heparyny przed zabiegiem liposukcji)
5.Zaburzenia krzepnięcia w wywiadzie i aktualne wyniki badań poza normą.
6.Stany zapalne skóry.
7.Uczulenia na leki stosowane w trakcie liposukcji ( np. Lignokaina i pochodne).
8.Stan po radioterapii lub chemioterapia
9.Każda inna choroba lub stan które mogą zmienić ocenę stanu skóry
(np. choroby autoimmunologiczne tkanki łącznej)
10.Przyjmowanie narkotyków kortykosteroidów lub leków cytotoksycznych w ciągu ostatnich 30 dni
11.Alergia na materiały pochodzenia od zwierzęcego
12.Rozpoznanie cukrzycy typu I
13.Rozpoznanie AIDS, HBV lub HCV (dodatni wynik badania laboratoryjnego)
14.Duże owłosienie lub tatuaż na miejscu zabiegu
15.Niewystarczająca tkanka tłuszczowa do pobrania tłuszczu
16.Blizna po usunięciu nowotworu złośliwego.
17.Pacjent w opinii badacza nie kwalifikuje się do udziału w tym badaniu
18.Ciąża, karmienie piersią.
19.Uczulenie na światło lub stosowanie leków powodujących reakcje fotouczulające
20.Aktywna opryszczka
21.Keloidy samoistne
22.Zabiegi estetyczne i lecznicze wykonywane wcześniej w okolicy poddanej badaniu
23.Stosowanie pochodnych witaminy A w ciągu 6 miesięcy przed zabiegiem
24.Fototyp V i VI wg Fitzpatrica
25.Pacjenci z zaburzeniami psychicznym lub uzależnieni od narkotyków i alkoholu.
26.Udział w innym badaniu klinicznym w ciągu ostatnich 6 miesięcy.
27.Reaktywny wynik badań serologicznych i wirusologicznych (tj. HIV-1 i 2 (HIV Ag/Ab)
•wirusowe zapalnie wątroby typu B – HbsAg i Anty HBc
•wirusowe zapalenie wątroby typu C – Anty-HCV
•kiła testy swoiste

E.5 End points

E.5.1

Primary end point(s)

Evaluation of the efficacy of the stem cell application method in the described indications by evaluating the time needed for 50% increase in patient’s quality of life.

Ocena skuteczności metody aplikacji komórek macierzystych w opisanych wskazaniach poprzez ocenę czasu po jakim nastąpi poprawa o 50% w punktowej oceny jakości życia pacjenta w stosunku do wartości wyjściowych

E.5.1.1

Timepoint(s) of evaluation of this end point

Time to first occurence.

Czas jaki upłynie do pierwszego wystąpienia

E.5.2

Secondary end point(s)

1.A change in the volume of fat layer in place of cells’ application evaluated by changes in the volume of the fat layer at the application site assessed by skin and subcutaneous tissue (USG) thickness and assessment of skin surface morphology by digital imaging according to guidelines in the Investigator's Guide.
2.A change in the structure of the tissue in place of application: the surface, the circumference, flexibility and thickness of tissue, color and texture in the opinion of the investigator and the patient.
3.Evaluation of safety of the method of cells’ application assessed by adverse events.
4.Estimation of the time and cost of the procedure during the study.

1.Zmiana objętości warstwy tłuszczowej w miejscu aplikacji oceniana poprzez zmianę grubości skóry i tkanki podskórnej (USG) oraz ocena zmiany morfologii powierzchni skóry za pomocą obrazowania cyfrowego wg wytycznych w Przewodniku Badacza.
2.Zmiana struktury tkanek miejsca aplikacji: powierzchnia, obwód, elastyczność i grubość tkanki, kolor i tekstura w ocenie badacza i pacjenta
3.Ocena bezpieczeństwa metody aplikacji preparatu komórkowego poprzez ocenę działań niepożądanych.
4.Oszacowanie czasu i kosztów procedury w trakcie eksperymentu

E.5.2.1

Timepoint(s) of evaluation of this end point

Time to first occurence.

Czas jaki upłynie do pierwszego wystąpienia.

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

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

Yes

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Laseroterapia w czasie trwania badania.

Laser therapy during the study period.

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

The patient’s participation in the research ends after 24-27 weeks since the first application.
The decision on the premature study termination may be taken if the investigators or the representatives of the consortium get knowledge of circumstances or events that indicate the likelihood the study may jeopardize patients’ health.

Zakończenie udziału pacjenta w badaniu następuje po 24-27 tyg. od pierwszej aplikacji.
Decyzja o przedwczesnym zakończeniu badania może być podjęta, jeśli badacze, przedstawiciele konsorcjum, posiądą wiedze o warunkach lub zdarzeniach, które wskazują na prawdopodobieństwo że kontynuowanie badania związane jest z zagrożeniem dla pacjentów.

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

100

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

100

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

Żadne

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

2017-12-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-07-06

P. End of Trial
P.	End of Trial Status	Completed

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