Clinical Trials Register

Summary
EudraCT Number:	2011-005435-98
Sponsor's Protocol Code Number:	version_2.0_dated_19.04.2011
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:	2012-02-24
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

2011-005435-98

A.3

Full title of the trial

A randomized, prospective, double-blind study with placebo to evaluate the efficacy of treatment of patients with angina resistant to pharmacological treatment and induced myocardial ischemia without possibility of effective revascularization, using isolated from bone marrow, autological CD133+ cells administered directly into the muscle of left ventricle. REGENT-VSEL Study.

Randomizowane, prospektywne, podwójnie zaślepione badanie z grupą placebo w celu oceny skuteczności leczenia pacjentów z oporną na leczenie farmakologiczne dławicą piersiową i indukowanym niedokrwieniem miokardium bez możliwości skutecznej rewaskularyzacji, za pomocą izolowanych ze szpiku kostnego autologicznych komórek CD133+ podawanych bezpośrednio do mięśnia lewej komory. Badanie REGENT-VSEL.

A.3.2

Name or abbreviated title of the trial where available

REGENT VSEL

A.4.1

Sponsor's protocol code number

version_2.0_dated_19.04.2011

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	Śląski Uniwersytet Medyczny w Katowicach
B.1.3.4	Country	Poland
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	autological CD133+ isolated from bone marrow
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	Other use (Noncurrent)
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.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	Other use (Noncurrent)

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Stable angina pectoris CCS II-IV

stabilna choroba wieńcowa CCS II-IV

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10049194
E.1.2	Term	Stable angina pectoris
E.1.2	System Organ Class	10007541 - Cardiac 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

1. Assessment of influence of direct administration of isolated from bone marrow, autological CD133+ cells on improvement of myocardial perfusion and function and decrease of occurrence of symptomatic angina of patients with angina resistant to pharmacological treatment without possibility of effective revascularization
2. Assessment of therapy safety

1. Ocena wpływu bezpośredniego podania izolowanych ze szpiku kostnego autologicznych komórek CD133+ na poprawę perfuzji i funkcji mięśnia sercowego oraz zmniejszenie dolegliwości dławicowych u pacjentów z oporną na leczenie dławicą bez możliwości wykonania rewaskularyzacji
2. Ocena bezpieczeństwa terapii

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Stable angina CCS II-IV despite maximum pharmacotherapy for at least 2 weeks since last medications change
2. Presence of ≥ 1 miocardium segment with ischemia features in Tc-99m SPECT
3. Patients disqualified from revascularization procedures by heart-team
4. Patient age > 18 and < 75 year old
5. Patient must provide written informed consent for participation in study

1. stabilna choroba wieńcowa CCS II-IV pomimo maksymalnej farmakoterapii przez co najmniej 2 tygodnie od ostatniej zmiany schematu stosowania leków.
2. obecność ≥ 1 segmentu miokardium z cechami niedokrwienia w Tc-99m SPECT
3. pacjenci zdyskwalifikowanie na konsylium kardiologiczno-kardiochirurgicznym od zabiegów rewaskularyzacji
4. wiek > 18 i < 75 rż.
5. wyrażenie świadomej zgody na uczestnictwo w badaniu

E.4

Principal exclusion criteria

1. acute coronary syndrome in less than 6 months prior to enrollment
2. heart failure NYHA III-IV
3. LVEF<35%
4. presence of intracardiac thrombus (echocardiography confirmed), massive calcification of the aortic valve and left ventricular aneurysm
5. status after cardioverter defibrillator or cardiac stimulator implantation
6. allergy to contrast agents
7. malignancy in medical interview
8. HIV, HBV, HCV infection
9. status associated with life expectancy less than 6 months
10. bleeding diathesis
11. renal insufficiency (GFR < 30 mL/min/1.73m2)
12. pregnancy, lactation, or lack of effective contraception in women of childbearing age

1. przebyty ostry zespół wieńcowy w okresie krótszym niż 6 miesięcy przed włączeniem do badania
2. niewydolność serca NYHA III-IV
3. LVEF<35%
4. potwierdzona w badaniu echokardiograficznym obecność skrzepliny wewnątrzsercowej, masywne zwapnienia zastawki aortalnej oraz tętniak lewej komory serca
5. stan po implantacji stymulatora lub kardiowertera defibrylatora
6. uczulenie na środki kontrastowe
7. nowotwór złośliwy w wywiadzie
8. zakażenie HIV, HBV, HCV
9. jakikolwiek stan związany z przewidywaną długością życia poniżej 6 miesięcy
10. skaza krwotoczna
11. niewydolność nerek (GFR < 30 mL/min/1.73m2)
12. ciąża, okres karmienia piersią lub brak skutecznej antykoncepcji u kobiet w wieku rozrodczym

E.5 End points

E.5.1

Primary end point(s)

Myocardial perfusion change assessed by perfusion scintigraphy
(99mTc SPECT) 4 months after application of cell therapy

Zmiana perfuzji mięśnia sercowego oceniana za pomocą scyntygrafii perfuzyjnej (99mTc SPECT) po 4 miesiącach od zastosowania terapii komórkowej

E.5.1.1

Timepoint(s) of evaluation of this end point

4 months after application of cell therapy

4 miesiące od zastosowania terapii komórkowej

E.5.2

Secondary end point(s)

1. global and segmental contractility change and myocardial perfusion change assessed by magnetic resonance imaging with adenosine administration, and echocardiography with contrast

2. exercise tolerance assessed in a treadmill test (TET, ESTD, TTLA)

3. occurrence of symptomatic angina (CCS, nitrates usage)
4. quality of life assessed by standard questionnaires (SF37, Seattle Angina)

1. zmiana globalnej i odcinkowej kurczliwości oraz perfuzji mięśnia sercowego oceniana metodą rezonansu magnetycznego z podaniem adenozyny oraz w badaniu echokardiograficznym z użyciem kontrastu
2. tolerancja wysiłku w teście obciążeniowym na bieżni ruchomej (TET, ESTD, TTLA)
3. występowanie dolegliwości dławicowych (CCS, użycie nitratów)
4. jakość życia oceniana za pomocą standardowych formularzy (SF37, Seattle Angina)

E.5.2.1

Timepoint(s) of evaluation of this end point

1. 4 months after application of cell therapy
2. 4 and 6 months after application of cell therapy
3. 1, 4, 6 and 12 months after application of cell therapy
4. 1, 4, 6 and 12 months after application of cell therapy

1. 4 miesiące od zastosowania terapii komórkowej
2. 4 i 6 miesięcy od zastosowania terapii komórkowej
3. 1, 4, 6 i 12 miesięcy od zastosowania terapii komórkowej
4. 1, 4, 6 i 12 miesięcy od zastosowania terapii komórkowej

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

E.8.2.4

Number of treatment arms in the trial

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

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.2.1	Number of subjects for this age range:	30
F.1.3	Elderly (>=65 years)	Yes
F.1.3.1	Number of subjects for this age range:	30
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	60

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

2012-06-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-05

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-09-05

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