Clinical Trials Register

Summary
EudraCT Number:	2015-000510-22
Sponsor's Protocol Code Number:	1-2014.4
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2015-05-08
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

Spain - AEMPS

A.2

EudraCT number

2015-000510-22

A.3

Full title of the trial

CLINICAL EFFICACY OF PLATELET GEL FROM CORD BLOOD FOR THE TREATMENT OF DIABETIC FOOT ULCERS

EFICACIA CLÍNICA DEL GEL DE PLAQUETAS DE SANGRE DE CORDÓN UMBILICAL PARA EL TRATAMIENTO DE ÚLCERAS DEL PIE DIABÉTICO

A.3.1

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

CLINICAL EFFICACY OF PLATELET GEL FROM CORD BLOOD FOR THE TREATMENT OF DIABETIC FOOT ULCERS

EFICACIA CLÍNICA DEL GEL DE PLAQUETAS DE SANGRE DE CORDÓN UMBILICAL PARA EL TRATAMIENTO DE ÚLCERAS DEL PIE DIABÉTICO

A.3.2

Name or abbreviated title of the trial where available

CLINICAL EFFICACY OF CBPG FOR THE TREATMENT OF DIABETIC FOOT ULCERS

EFICACIA CLÍNICA DE CBPG PARA EL TRATAMIENTO DE ÚLCERAS DEL PIE DIABÉTICO

A.4.1

Sponsor's protocol code number

1-2014.4

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	Banc de Sang i Teixits
B.1.3.4	Country	Spain
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	Banc de Sang i Teixits
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Banc de Sang i Teixits
B.5.2	Functional name of contact point	Departamento de I+D+i
B.5.3	Address:
B.5.3.1	Street Address	Passeig Taulat 116
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08005
B.5.3.4	Country	Spain
B.5.4	Telephone number	34935573500
B.5.5	Fax number	34935573502
B.5.6	E-mail	etahull@bst.cat

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	Gel de plaquetas de sangre de cordón umbilical
D.3.2	Product code	Gel de plaquetas de sangre de cordón umbilical
D.3.4	Pharmaceutical form	Gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Gel de plaquetas de sangre de cordón umbilical
D.3.9.2	Current sponsor code	CBPG
D.3.9.3	Other descriptive name	PLAQUETAS, SANGRE HUMANA
D.3.9.4	EV Substance Code	SUB127875
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5 to 15
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	Yes
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 ulcers

Úlceras del pie diabético

E.1.1.1

Medical condition in easily understood language

Diabetic foot ulcers

Úlceras del pie diabético

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

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	10012664
E.1.2	Term	Diabetic foot ulcer
E.1.2	System Organ Class	100000004858

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To increase ulcer?s healing from 40% in controls to >60% in treated patients

Aumentar la curación de las úlceras desde un 40% en los controles hasta por lo menos un 60% en los pacientes tratados con CBPG

E.2.2

Secondary objectives of the trial

Percent skin ulcer closure area.

Number and type of adverse events that will occur in diabetic patients during treatment period.

Cost of treatment.

Porcentaje del área de la úlcera cutánea cerrada.

Número y tipo de acontecimientos adversos de los pacientes diabéticos durante el periodo de tratamiento.

Coste del tratamiento

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients >18 year with diabetic ulcer
2. Ulcer dimensions (5cm2 < X < 20cm2)
3. Undermining or tunneling
4. TUC I and II C. At the time of 1st application, ulcer is not clinically infected (smelly, tissue, hot and flushed perilesional edematous)
5. General conditions of Patient:
a. Controlled diabetes (HbA1c <9)
b. Albumin > 2.5g/dl
6. Informed consent
7. Patient able to understand the conditions of the study and to participate for its entire duration

1. Pacientes > 18 años con úlcera diabética
2. Dimensiones de la úlcera (5cm2 < X < 20cm2)
3. Debilitamiento o túneles
4. TUC I y II C. En el momento de la primera aplicación, la úlcera no está infectada clínicamente (maloliente, tejido, caliente y enrojecimiento perilesional edematoso).
5. Condiciones generales del Paciente:
a. Diabetes controlada (HbA1c<9)
b. Albúmina > 2.5g/dl
6. Consentimiento informado
7. Paciente capaz de entender las condiciones del estudio y de participar en él durante toda su duración

E.4

Principal exclusion criteria

1. Patient with serious medical conditions that contraindicate the patient's participation in the study (tumors, severe chronic renal failure, autoimmune diseases, severe ischemic heart disease)
2. Patient with uncontrolled diabetes mellitus (HbA1c >9) or severe metabolic diseases
3. Heel ulcer and outcomes of amputation
4. Patient with present clinical infection
5. Bone exposure
6. Patient taking or having taken chronically drugs that can affect the metabolism, and in general regeneration and tissue repair (bisphosphonates, chemotherapy, chronic therapy with corticosteroids)
7. Use of experimental drugs
8. Patients not able to follow the procedures of the Protocol and to sign the informed consent.
9. Current pregnancy
10. Negative Pressure (possible use in control arm patients)

1. Paciente con condiciones médicas graves que contraindican su participación en el estudio (tumores, insuficiencia renal crónica grave, enfermedades autoinmunes, enfermedad isquémica severa)
2. Paciente con diabetes mellitus no controlada (HbA1c> 9) o enfermedades metabólicas graves
3. Úlcera del talón y resultados de amputación
4. Paciente con infección clínica presente
5. Hueso expuesto
6. El paciente toma o ha tomado medicamentos crónicos que pueden afectar el metabolismo, y en general la regeneración y la reparación de tejidos (bifosfonatos, quimioterapia, tratamiento crónico con corticoides)
7. Uso de medicamentos experimentales
8. Pacientes incapaces de seguir los procedimientos del Protocolo y firmar el consentimiento informado.
9. Embarazo actual
10. Presión Negativa (posible uso en los pacientes del grupo control)

E.5 End points

E.5.1

Primary end point(s)

Percent reduction (100% = healing) of ulcer's size

Porcentaje de reducción (100% = curación) del tamaño de la úlcera

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 4 of treatment

Semana 4 de tratamiento

E.5.2

Secondary end point(s)

Ulcer's infection, osteomyelitis, amputation, AE monitored with CTCAE v 3.0

Infección de la úlcera, osteomielitis, amputación, AE según CTCAE v 3.0

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 4 of treatment

Semana 4 de tratamiento

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

Yes

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

The platelet gel has been administered to humans before but not x treatment of diabetic foot ulcer

El gel de plaquetas se ha administrado antes a humanos pero no para tratamiento úlcera pie diabético

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

Yes

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

Last Patient Last Visit

Última visita del último paciente

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 months

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.4.2

For a multinational trial

F.4.2.1

In the EEA

220

F.4.2.2

In the whole clinical trial

220

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)

If the ulcer has healed, but has not closed a 100% of its size (at week 4 of treatment) it is foressen that the treatment can continue for several weeks more

Si la úlcera se ha curado, pero no se ha cerrado al 100% (en la semana 4 de tratamiento) se prevé poder prolongar el tratamiento durante algunas semanas más.

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

2015-07-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-03-25

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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