HorStem

European Union - English - EMA (European Medicines Agency)

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Active ingredient:
equine umbilical cord mesenchymal stem cells
Available from:
EquiCord-Ymas S.L.
ATC code:
QM09AX
INN (International Name):
equine umbilical cord mesenchymal stem cells
Therapeutic group:
Horses
Therapeutic area:
Other drugs for disorders of the musculo-skeletal system
Therapeutic indications:
Reduction of lameness associated with mild to moderate degenerative joint disease (osteoarthritis) in horses.
Authorization status:
Authorised
Authorization number:
EMEA/V/C/004265
Authorization date:
2019-06-19
EMEA code:
EMEA/V/C/004265

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Patient Information leaflet Patient Information leaflet - Bulgarian

01-01-1970

Summary of Product characteristics Summary of Product characteristics - Bulgarian

01-01-1970

Public Assessment Report Public Assessment Report - Bulgarian

01-01-1970

Patient Information leaflet Patient Information leaflet - Spanish

01-01-1970

Summary of Product characteristics Summary of Product characteristics - Spanish

01-01-1970

Public Assessment Report Public Assessment Report - Spanish

01-01-1970

Patient Information leaflet Patient Information leaflet - Czech

01-01-1970

Public Assessment Report Public Assessment Report - Czech

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Patient Information leaflet Patient Information leaflet - Danish

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Public Assessment Report Public Assessment Report - Danish

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Patient Information leaflet Patient Information leaflet - German

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Public Assessment Report Public Assessment Report - German

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Patient Information leaflet Patient Information leaflet - Estonian

01-01-1970

Summary of Product characteristics Summary of Product characteristics - Estonian

01-01-1970

Public Assessment Report Public Assessment Report - Estonian

01-01-1970

Patient Information leaflet Patient Information leaflet - Greek

01-01-1970

Public Assessment Report Public Assessment Report - Greek

01-01-1970

Patient Information leaflet Patient Information leaflet - French

01-01-1970

Public Assessment Report Public Assessment Report - French

01-01-1970

Patient Information leaflet Patient Information leaflet - Italian

01-01-1970

Summary of Product characteristics Summary of Product characteristics - Italian

01-01-1970

Public Assessment Report Public Assessment Report - Italian

01-01-1970

Patient Information leaflet Patient Information leaflet - Latvian

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Summary of Product characteristics Summary of Product characteristics - Latvian

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Public Assessment Report Public Assessment Report - Latvian

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Patient Information leaflet Patient Information leaflet - Lithuanian

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Summary of Product characteristics Summary of Product characteristics - Lithuanian

01-01-1970

Public Assessment Report Public Assessment Report - Lithuanian

01-01-1970

Patient Information leaflet Patient Information leaflet - Hungarian

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Summary of Product characteristics Summary of Product characteristics - Hungarian

01-01-1970

Public Assessment Report Public Assessment Report - Hungarian

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Patient Information leaflet Patient Information leaflet - Maltese

01-01-1970

Summary of Product characteristics Summary of Product characteristics - Maltese

01-01-1970

Public Assessment Report Public Assessment Report - Maltese

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Patient Information leaflet Patient Information leaflet - Dutch

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Public Assessment Report Public Assessment Report - Dutch

01-01-1970

Patient Information leaflet Patient Information leaflet - Polish

01-01-1970

Public Assessment Report Public Assessment Report - Polish

01-01-1970

Patient Information leaflet Patient Information leaflet - Portuguese

01-01-1970

Summary of Product characteristics Summary of Product characteristics - Portuguese

01-01-1970

Public Assessment Report Public Assessment Report - Portuguese

01-01-1970

Patient Information leaflet Patient Information leaflet - Romanian

01-01-1970

Summary of Product characteristics Summary of Product characteristics - Romanian

01-01-1970

Public Assessment Report Public Assessment Report - Romanian

01-01-1970

Patient Information leaflet Patient Information leaflet - Slovak

01-01-1970

Public Assessment Report Public Assessment Report - Slovak

01-01-1970

Patient Information leaflet Patient Information leaflet - Slovenian

01-01-1970

Summary of Product characteristics Summary of Product characteristics - Slovenian

01-01-1970

Public Assessment Report Public Assessment Report - Slovenian

01-01-1970

Patient Information leaflet Patient Information leaflet - Finnish

01-01-1970

Summary of Product characteristics Summary of Product characteristics - Finnish

01-01-1970

Public Assessment Report Public Assessment Report - Finnish

01-01-1970

Patient Information leaflet Patient Information leaflet - Swedish

01-01-1970

Summary of Product characteristics Summary of Product characteristics - Swedish

01-01-1970

Public Assessment Report Public Assessment Report - Swedish

01-01-1970

Patient Information leaflet Patient Information leaflet - Norwegian Bokmål

01-01-1970

Summary of Product characteristics Summary of Product characteristics - Norwegian Bokmål

01-01-1970

Patient Information leaflet Patient Information leaflet - Icelandic

01-01-1970

Summary of Product characteristics Summary of Product characteristics - Icelandic

01-01-1970

Patient Information leaflet Patient Information leaflet - Croatian

01-01-1970

Summary of Product characteristics Summary of Product characteristics - Croatian

01-01-1970

Public Assessment Report Public Assessment Report - Croatian

01-01-1970

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

HorStem suspension for injection for horses

1.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF

THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH

RELEASE, IF DIFFERENT

EquiCord-YMAS

103-D Loeches

Polígono Industrial Ventorro del Cano

Alcorcón

28925 Madrid

Spain

Phone: +34 (0) 914856756

E-mail: horstem@equicord.com

2.

NAME OF THE VETERINARY MEDICINAL PRODUCT

HorStem suspension for injection for horses

3.

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each vial contains:

Active Substance: 15x10

Equine umbilical cord mesenchymal stem cells

Excipient:

Adenosine

Dextran-40

Lactobionic acid

HEPES N-(2-hydroxyethyl) piperazine-N´-(2-ethanesulfonic acid)

Sodium hydroxide

L- Glutathione

Potassium chloride

Potassium bicarbonate

Potassium phosphate

Dextrose

Sucrose

Mannitol

Calcium chloride

Magnesium chloride

Potassium hydroxide

Sodium hydroxide

Trolox (6-hydroxyl-2,5,7,8- tetramethylchroman-2-carboxylic acid)

Water for injections

Suspension for injection.

Cloudy colourless suspension.

4.

INDICATION

Reduction of lameness associated with mild to moderate degenerative joint disease (osteoarthritis) in

horses.

5.

CONTRAINDICATIONS

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

6.

ADVERSE REACTIONS

Very common

Acute synovitis with an acute onset of severe lameness, joint effusion and pain on palpation was

reported 24 hours after administration of the veterinary medicinal product. Substantial

improvement was shown in the next 48 hours and complete remission in the following two

weeks. In case of severe inflammation, administration of symptomatic treatment with Non-

Steroidal Anti-Inflammatory Drugs (NSAIDs) could be necessary.

Common

Moderate joint effusion with no associated lameness has been observed 24 hours after HorStem

administration. Complete remission was observed over the following two weeks without any

symptomatic treatment.

An increase in mild lameness was observed 24 hours after HorStem administration. Complete

remission was observed within 3 days, without any symptomatic treatment.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports)

If you notice any side effects, even those not already listed in this package

leaflet or you think that the

medicine has not worked, please inform your veterinary surgeon.

7.

TARGET SPECIES

Horses.

8.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Route of administration:

Intraarticular use.

Dosage

A single intraarticular injection of 1 ml (15x10

equine umbilical cord mesenchymal stem cells) into

the affected joint.

Method of administration

The veterinary product must be administered intraarticularly, only by a veterinary surgeon, taking

special precautions to ensure the sterility of the injection process. The product must be handled and

injected following sterile techniques and in a clean environment.

Swirl gently before use in order to ensure the contents are well mixed.

9.

ADVICE ON CORRECT ADMINISTRATION

Do not apply simultaneously with other intraarticular veterinary medicinal products.

The product should only be administered by a veterinary surgeon.

Use a 20G needle.

Intraarticular placement should be confirmed by the appearance of synovial fluid in the hub of the

needle.

10.

WITHDRAWAL PERIOD

Zero days.

11.

SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store and transport refrigerated (2

C – 8

Do not freeze.

Do not use this veterinary medicinal product after the expiry date which is stated on the vial label.

12.

SPECIAL WARNINGS

Special warnings for each target species:

The veterinary medicinal product was demonstrated to be efficacious in horses affected by

osteoarthritis in the metacarpo-phalangeal joint, distal interphalangeal joint, and tarsometatarsal/ distal

intertarsal joint. No efficacy data are available regarding the treatment of other joints.

No efficacy data are available regarding the treatment in more than one arthritic joint at the same time.

The onset of efficacy may be gradual. Efficacy data demonstrated an effect from 35 days after

treatment

Special precautions for use in animals

Correct placement of the needle is crucial to avoid accidental injection into blood vessels and an

associated risk of thrombosis.

The safety of the veterinary medicinal product has only been investigated in horses at least two years

old.

Special precautions to be taken by the person administering the veterinary medicinal product to

animals:

Care should be taken to avoid accidental self-injection.

Wash hands after use.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or

the label to the physician.

Pregnancy and lactation:

The safety of the veterinary medicinal product has not been established during pregnancy and

lactation.

Use only accordingly to the benefit/risk assessment by the responsible veterinarian.

Interaction with other medicinal products and other forms of interactions

Do not administer simultaneously with any other intraarticular veterinary medicinal product.

Overdose (symptoms, emergency procedures, antidotes):

Intraarticular administration of a 2x dose (30x10

/2ml) of HorStem to 4 years old and older healthy

horses led to lameness in 5/6 animals and to signs of inflammation in all animals. In 5/6 horses, the

adverse reactions were mild and resolved spontaneously within 28 days. One horse required

symptomatic treatment (NSAID) and its lameness resolved by day 14.

A second administration of the product at the recommended dose to healthy young horses in the same

joint, 28 days after the first administration at the recommended dose, led to an increase in frequency

and severity of inflammation related to the treated joint (8/8 horses) and to an increase in the severity

of the lameness observed (3/8 horses; up to grade 4/5 according to the American Association of

Equine Practitioners lameness scale (AAEP))

compared to the first treatment. In one case,

symptomatic treatment (NSAID) was requiredAdverse reactions in the other horses resolved

spontaneously within a maximum of 21 days; lameness lasted for up to three days.

Incompatibilities:

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with any

other veterinary medicinal products.

13.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE

MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste.

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should

help to protect the environment.

14.

DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency: http://www.ema.europa.eu/

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

HorStem suspension for injection for horses

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 1 ml dose contains:

Active substance:

Equine umbilical cord mesenchymal stem cells (EUC-MSCs)

15x10

Excipients:

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Suspension for injection.

Cloudy colourless suspension.

4.

CLINICAL PARTICULARS

4.1

Target species

Horses.

4.2

Indications for use, specifying the target species

Reduction of lameness associated with mild to moderate degenerative joint disease (osteoarthritis) in

horses.

4.3

Contraindications

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

4.4

Special warnings for each target species

The veterinary medicinal product was demonstrated to be efficacious in horses affected by osteoarthritis in

the metacarpo-phalangeal joint, distal interphalangeal joint, and tarsometatarsal/ distal intertarsal joint. No

efficacy data are available regarding the treatment of other joints.

No efficacy data are available regarding the treatment in more than one arthritic joint at the same time.

The onset of efficacy may be gradual. Efficacy data demonstrated an effect from 35 days after treatment.

4.5

Special precautions for use

Special precautions for use in animals

Correct placement of the needle is crucial to avoid accidental injection into blood vessels and an

associated risk of thrombosis.

The safety of the veterinary medicinal product has only been investigated in horses at least two years old.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Care should be taken to avoid accidental self-injection.

Wash hands after use.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the

label to the physician.

4.6

Adverse reactions (frequency and seriousness)

Very common:

Acute synovitis with an acute onset of severe lameness, joint effusion and pain on palpation was reported

24 hours after administration of the veterinary medicinal product. Substantial improvement was shown in

the next 48 hours and complete remission in the following two weeks. In case of severe inflammation,

administration of symptomatic treatment with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) could

be necessary.

Common:

Moderate joint effusion with no associated lameness has been observed 24 hours after HorStem

administration. Complete remission was observed over the following two weeks without any symptomatic

treatment.

An increase in mild lameness was observed 24 hours after HorStem administration. Complete remission

was observed within 3 days, without any symptomatic treatment.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7

Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Use only accordingly to the benefit/risk assessment by the responsible veterinarian.

4.8

Interaction with other medicinal products and other forms of interaction

Do not administer simultaneously with any other intraarticular veterinary medicinal product.

4.9

Amounts to be administered and administration route

Route of administration:

Intraarticular use.

Dosage:

A single intraarticular injection of 1 ml (15x10

equine umbilical cord mesenchymal stem cells) into the

affected joint.

Method of administration:

The veterinary product must be administered intraarticularly, only by a veterinary surgeon, taking special

precautions to ensure the sterility of the injection process. The product must be handled and injected

following sterile techniques and in a clean environment.

Swirl gently before use in order to ensure the contents are well mixed.

Use a 20G needle.

Intraarticular placement should be confirmed by the appearance of synovial fluid in the hub of the needle.

4.10

Overdose (symptoms, emergency procedures, antidotes), if necessary

Intraarticular administration of a 2x dose (30x10

/2ml) of HorStem to 4 years old and older healthy horses

led to lameness in 5/6 animals and to signs of inflammation in all animals. In 5/6 horses, the adverse

reactions were mild and resolved spontaneously within 28 days. One horse required symptomatic

treatment (NSAID) and its lameness resolved by day 14.

A second administration of the product at the recommended dose to healthy young horses in the same

joint, 28 days after the first administration at the recommended dose, led to an increase in frequency and

severity of inflammation related to the treated joint (8/8 horses) and to an increase in the severity of the

lameness observed (3/8 horses; up to grade 4/5 according to the American Association of Equine

Practitioners lameness scale (AAEP)) compared to the first treatment. In one case, symptomatic treatment

(NSAID) was required. Adverse reactions in the other horses resolved spontaneously within a maximum

of 21 days; lameness lasted for up to three days.

4.11

Withdrawal period(s)

Zero days.

5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Not yet assigned

ATCvet code: Not yet assigned

5.1

Pharmacodynamic properties

Mesenchymal stem cells have immunomodulatory and anti-inflammatory properties that may be attributed

to their paracrine activity, -e.g. prostaglandin (PGE2) secretion, and can possess tissue regenerative

properties. These pharmacodynamic properties may be also relevant for equine umbilical cord derived

MSCs (EUC-MSCs) but have not been demonstrated in proprietary studies conducted with the product.

The potential of EUC-MSCs to secrete PGE2 with and without stimulation by synovial fluid has been

demonstrated in studies

in vitro

5.2

Pharmacokinetic particulars

To what extent EUC-MSCs from this product persist after intraarticular administration to horses is not

known as no proprietary biodistribution studies have been conducted with HorStem.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Adenosine

Dextran-40

Lactobionic acid

HEPES N-(2-hydroxyethyl) piperazine-N´-(2-ethanesulfonic acid)

Sodium hydroxide

L- Glutathione

Potassium chloride

Potassium bicarbonate

Potassium phosphate

Dextrose

Sucrose

Mannitol

Calcium chloride

Magnesium chloride

Potassium hydroxide

Sodium hydroxide

Trolox (6-hydroxyl-2,5,7,8- tetramethylchroman-2-carboxylic acid)

Water for injections

6.2

Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with any

other veterinary medicinal products.

6.3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 14 days.

Shelf life after first opening the immediate packaging: Use immediately.

6.4

Special precautions for storage

Store and transport refrigerated (2

C – 8

Do not freeze.

6.5

Nature and composition of immediate packaging

Cyclic olefin vial closed with a bromobutyl rubber stopper and a flip off aluminium cap.

Pack size: Cardboard box with 1 vial containing 1 ml.

6.6

Special precautions for the disposal of unused veterinary medicinal product or waste

materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal

product should be disposed of in accordance with local requirements.

7.

MARKETING AUTHORISATION HOLDER

EquiCord-YMAS S.L.

103-D Loeches

Polígono. Industrial Ventorro del Cano

Alcorcón

28925 Madrid

Spain

Tel:

+34 (0) 914856756

E-mail:

horstem@equicord.com

8.

MARKETING AUTHORISATION NUMBER(S)

EU/2/18/226/001

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 19/06/2019

10

DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency (http://www.ema.europa.eu/

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

Official address

Domenico Scarlattilaan 6

1083 HS Amsterdam

The Netherlands

An agency of the European Union

Address for visits and deliveries

Refer to www.ema.europa.eu/how-to-find-us

Send us a question

Go to www.ema.europa.eu/contact

Telephone

+31 (0)88 781 6000

© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.

EMA/162149/2019

EMEA/V/C/004265

HorStem (equine umbilical cord mesenchymal stem cells)

An overview of HorStem and why it is authorised in the EU

What is HorStem and what is it used for?

HorStem is a veterinary medicine used to treat lameness associated with mild to moderate

degenerative joint disease (osteoarthritis) in horses. It contains the active substance equine umbilical

cord mesenchymal stem cells. These are stem cells taken from the umbilical cord of donor horses when

a foal is born and grown in a laboratory to increase their numbers. Stem cells can develop into other

types of cells.

How is HorStem used?

The medicine can only be obtained with a prescription. HorStem is given only by a veterinarian as a

single injection into the affected joint.

For more information about using HorStem, see the package leaflet or contact your veterinarian or

pharmacist.

How does HorStem work?

It is not clear exactly how HorStem works in horses with osteoarthritis. Mesenchymal stem cells can

have effects on the immune system as well as anti-inflammatory effects and can possess tissue

regenerative properties. These properties are expected to play a role in the effect of HorStem.

What benefits of HorStem have been shown in studies?

In a field study of horses with mild to moderate osteoarthritis, 16 horses received an injection of

HorStem into the affected joint and 17 horses received a placebo (dummy) injection. Horses were

examined at days 14, 35 and 63. Treatment success was a reduction in lameness to a grade of 1 or

less, using an accepted scale for equine lameness measurement (scale from 0 to 5, where 0 is non-

lame, and 5 is severely lame). Twelve HorStem treated horses were successfully treated (success rate

75%) at day 63 compared to only 4 of the control group (success rate 25%).

HorStem (equine umbilical cord mesenchymal stem cells)

EMA/162149/2019

Page 2/2

What are the risks associated with HorStem?

The most common side effect with HorStem (which may affect more than 1 in 10 horses) is short-lived

synovitis (inflammation of the joint lining) with severe lameness, joint effusion (increased fluid in the

joint) and pain on palpation 24 hours after injection. Substantial improvement occurs in the next 48

hours with complete resolution in the following two weeks. In case of severe inflammation, treatment

with an anti-inflammatory medicine (NSAID) might be necessary.

For the full list of side effects and restrictions, see the package leaflet.

What are the precautions for the person who gives the medicine or comes

into contact with the animal?

Hands should be washed after handling the medicine.

Care should be taken to avoid accidental self-injection. In case of accidental self-injection, medical

advice should be sought immediately and the package leaflet or label shown to the doctor.

What is the withdrawal period in food-producing animals?

The withdrawal period is the time required after administration of a medicine before an animal can be

slaughtered and the meat used for human consumption.

The withdrawal period for meat from horses treated with HorStem is ‘zero’ days, which means that

there is no mandatory waiting time.

Why is HorStem authorised in the EU?

The European Medicines Agency decided that HorStem’s benefits are greater than its risks and it can

be authorised for use in the EU.

Other information about HorStem

HorStem received a marketing authorisation valid throughout the EU on 19 June 2019.

Further information on HorStem can be found on the Agency’s website:

ema.europa.eu/medicines/veterinary/EPAR/horstem.

This overview was last updated in February 2019.

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