Clinical Trials Register

Summary
EudraCT Number:	2015-003584-11
Sponsor's Protocol Code Number:	MACT-IBK-2015
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-09-04
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

Austria - BASG

A.2

EudraCT number

2015-003584-11

A.3

Full title of the trial

Matrix-associated autologous chrondrocyte transplantation for grade four cartilage lesions of the knee joint -
clinical and radiological outcome in correlation to the initial cell count of the chondrocyte graft

Matrix-assoziierte autologe Chondrozytentransplantation beim viertgradigen Knorpeldefekt des Kniegelenkes
- Klinisches und radiologisches Outcome in Korrelation zur initialen Zellzahl im Transplantat -

A.3.1

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

Evaluation of matrix-associated autologous chondrocyte transplantation as treatment of cartilage lesions of the knee joint

Evaluierung der matrix-assoziierten autologen Chondrozytentransplantation als Behandlung von Knorpeldefekten des Kniegelenkes

A.3.2

Name or abbreviated title of the trial where available

MACT

A.4.1

Sponsor's protocol code number

MACT-IBK-2015

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 Innsbruck
B.1.3.4	Country	Austria
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	none
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Univ.-Klinik für Unfallchirurgie
B.5.2	Functional name of contact point	Univ.-Klinik für Unfallchirurgie
B.5.3	Address:
B.5.3.1	Street Address	Anichstrae35
B.5.3.2	Town/ city	Innsbruck
B.5.3.4	Country	Austria
B.5.4	Telephone number	004351250480752

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	Yes
D.2.1.1.1	Trade name	ATMP-Matrix associated autologous chondrocyte transplantation
D.2.1.2	Country which granted the Marketing Authorisation	Austria
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	MACT
D.3.4	Pharmaceutical form	Implantation matrix
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Implantation
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MACT
D.3.9.3	Other descriptive name	MATRIX-INDUCED AUTOLOGOUS CHONDROCYTES
D.3.9.4	EV Substance Code	SUB31225
D.3.10	Strength
D.3.10.1	Concentration unit	billion organisms billion organisms
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.00000075 to 0.000004
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	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

Cartilage lesion

Läsionen des Gelenkknorpels, Knorpeldefekte

E.1.1.1

Medical condition in easily understood language

Cartilage lesion

Läsionen des Gelenkknorpels, Knorpeldefekte

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10072638
E.1.2	Term	Articular cartilage defect
E.1.2	System Organ Class	100000004859

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10064113
E.1.2	Term	Cartilage allograft
E.1.2	System Organ Class	100000004865

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 objective of this study is to evaluate the clinical and radiological outcome (MRT) after MACT and to correlate these findings with the initial cell count of the chondrocyte graft. What is more, further knowledge about additional factors influencing the outcome of the surgery may be gained. This pilot study could provide valuable data for the design of a prospective randomized clinical trial.

Ziel dieser Studie ist die Evaluierung des klinischen und radiologischen Outcomes (MRT) nach MACT und die Korrelation zur initialen Zellzahl des Knorpeltransplantates bei der Operation. Außerdem sollen Erkenntnisse über mögliche andere Einflussfaktoren auf das Outcome gewonnen werden. Dies ist eine Pilot Studie, welche eine Datenbasis zur Planung einer prospektiv randomisierten Studie liefern kann.

E.2.2

Secondary objectives of the trial

Localization of the lesion (medial/lateral femural condyle, patella, trochlea)
Age and sex
Lesion size

Defektlokalisation (medialer/lateraler Femurkondyl, Patella, Trochlea)
Alter und Geschlecht
Defektgröße

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Grade four chondral or osteochondral lesion of the knee joint, treated with MACT
- Defect size > 2cm²
- Patient age at the date of follow up: 18-65 years

Viertgradige chondrale oder osteochondrale Läsion des Kniegelenkes, mittels MACT versorgt
- Defektgröße > 2 cm2
- Patientenalter zum Zeitpunkt der Verlaufskontrolle: 18 – 65 Jahre

E.4

Principal exclusion criteria

- Patient age at the date of follow up < 18 or > 65 years
- Current history of knee instability
- Malalignment (varus/valgus ≥ 5° and not corrected during surgery or despite correction)
- Previous surgeries or injuries to the hyaline cartilage of the affected knee joint
- Congenital malformation of the lower extremity
- Medical secondary diagnosis which could influence cartilage metabolism
- Medical therapies which could influence cartilage metabolism
- Secondary diagnosis (e.g. neurological) which could influence physiological weight bearing
- Contraindication to MRI
- Patient is not able to obtain informed consent due to physical or mental disability
- Patient has no legal capacity

Alter zum Zeitpunkt der Verlaufskontrolle < 18 oder > 65 Jahre
- Instabilität des Kniegelenkes
- Achsenfehlstellung (Varus/Valgus ≥ 5°) (nicht korrigiert i.R. des Eingriffs oder trotz Korrektur)
- Vorherige Operationen oder Verletzungen des hyalinen Knorpels des betroffenen Kniegelenkes
- Angeborene Fehlbildungen der unteren Extremität
- Medizinische Nebendiagnosen die den Knorpelstoffwechsel beeinflussen können
- Medikamentöse Therapien die den Knorpelstoffwechsel beeinflussen können
- Neurologische Nebendiagnosen die eine physiologische Belastung der unteren Extremitäten
beeinflussen könnten
- Kontraindikationen gegen eine MRT
- Patient kann in Folge körperlicher oder geistiger Behinderung Einwilligung nicht erteilen
- Patient ist nicht voll geschäftsfähig

E.5 End points

E.5.1

Primary end point(s)

- Clinical outcome: Short Form 36 (SF-36), WOMAC, IKDC
- Radiological outcome: MOCART-Score assessed on MRI
- Initial cell count of the chondrocyte graft (f.e. according to the report of Novocart 3D-XL, or as available)

- Klinisches Outcome: Short Form 36 (SF-36)2, 8, WOMAC5, 9, IKDC9, 12
- Radiologisches Outcome (quantifiziert in der MRT mittels MOCART-Score)
- Initiale Knorpelzellzahl im Transplantat (z.B. entsprechend dem Ausgangsprüfbericht der Fa. Novocart® 3D-XL, bzw. soweit vorliegend)

E.5.1.1

Timepoint(s) of evaluation of this end point

5-9 years after surgery.

5-9 Jahre nach Operation

E.5.2

Secondary end point(s)

- Localization of the lesion (medial/lateral femural condyle, patella, trochlea)
- Age and sex

Nebenzielparameter
- Defektlokalisation (medialer/lateraler Femurkondyl, Patella, Trochlea)
- Alter und Geschlecht

E.5.2.1

Timepoint(s) of evaluation of this end point

9 years after Initial surgery.

9 Jahre nach Operation

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

E.6.4

Safety

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)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

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.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

only one visit planned (Long-term visit)

Langzeituntersuchung, nur eine Visite geplant

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

keine

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

2015-12-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-10-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-05-12

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