Biotherapies developed and manufactured in France in compliance with good practices
Clinical studies based on real animal treatments
Easy to use products, delivered solely by veterinarians
Précédent
Suivant
Biotherapies developed and manufactured in France in compliance with good practices
Clinical studies based on real animal treatments
Easy to use products, delivered solely by veterinarians
Précédent
Suivant

J – Biosafety evaluation of equine umbilical cord-derived mesenchymal stromal cells (UC-MSCs) by systematic pathogen screening in peripheral maternal blood and paired UC-MSCs

- Denys, A - Léon, A - Robert, C - Saulnier, N - Josson-Schramme, A - Legrand, L -Wimel, L - Maddens, S ? Pronost,

Background: The growing interest in mesenchymal stromal cells (MSCs) in equine medicine, together with the development of MSC biobanking for allogeneic use, raises concerns about biosafety of such products. MSCs derived from umbilical cord (UC) carry an inherent risk of contamination by environmental conditions and vertical transmission of pathogens from broodmares. There is yet no report in the scientific literature about horses being contaminated by infected MSC products, and no consensus about systematic infectious screening of umbilical cord-derived mesenchymal stromal cells (UC-MSCs) to ensure microbiological safety of therapeutic products.

Objectives: To develop a standard protocol to ensure UC-MSC microbiological safety and to assess the risk of vertical transmission of common intracellular pathogens from broodmares to paired UC-MSCs.

Materials and Methods: : Eighty-four UC and paired peripheral maternal blood (PMB) samples were collected between 2014 and 2016. Sterility was monitored by microbiological control tests. Maternal contamination was tested by systematical PMB PCR screening for 14 pathogens and a Coggins test. In case of a PCR-positive result regarding one or several pathogen(s) in PMB, a PCR analysis for the detected pathogen(s) was then conducted on the associated UC-MSCs.

Results: : Ten out of 84 UC samples were contaminated upon extraction and 6/84 remained positive in primo culture. The remaining 78/84 paired PMB & UC-MSC samples were evaluated for vertical transmission; 37/78 PMB samples were PCR positive for Equid herpesvirus (EHV)-1, EHV-2, EHV-5, Theileria equi, Babesia caballi, and/or Mycoplasma spp. Hepacivirus was detected in 2/27 cases and Theiler Diseases Associated Virus in 0/27 cases (not performed on all samples due to late addition). All paired UC-MSC samples tested for the specific pathogen(s) detected in PMB were negative (37/37).

Main Limitations: More data are needed regarding MSC susceptibility to most pathogens detected in PMB.

Conclusions: In-process microbiological controls combined with PMB PCR screening provide a comprehensive assessment of UC-MSC exposure to infectious risk, vertical transmission risk appearing inherently low.

For Veterinarians only

For Veterinarians only

Ask your veterinarian for the price of a stem cell injection at his clinic.

Product Pipeline

Range Product Development & optimization Proof of Concept Pilot study Industrialisation /
Manufacturing
Pivotal study Approval Marketing Launch

CANIPREN

VBX-01
Canine osteoarthritis

VBX-01
Canine osteoarthritis

VBX-01
Canine osteoarthritis

CA0102
Atopic dermatitis

CA0103
Atopic dermatitis
Chronic
Inflammatory
Bowel
Disease

Range Product Development & optimization Proof of Concept Pilot study Industrialisation /
Manufacturing
Pivotal study Approval Marketing Launch

FELIPREN

FE0101
Gingivostomatitis

FE0102
Chronic kidney
failure

FE0103
Feline arthrosis

Range Product Development & optimization Proof of Concept Pilot study Industrialisation /
Manufacturing
Pivotal study Approval Marketing Launch

EQUIPREN
OMBISTEM

EQ0101
Equine arthrosis