Tissue processing and sample clearing in GMP cleanroom

SAFETY REGULATION

• Multiple layers of protection
• Controlled and regulated environment
• Testing of manufacturing space for contaminates throughout the process
• Testing for sterility and endotoxins, karyotype analysis & viability

QUALITY CONTROL

• Developed and validated procedures to meet strict, consistent product specifications
• Documentation and review of each step to confirm adherence to Standard Operating Procedures (SOP) and policies
• Review and sign off by the quality assurance department (a certificate of analysis is included in each batch) after rigorous third-party and internal quality testing
• Immunological and analysis testing for stability & cell health to certify products offer a consistent yield

• Immediate relief can result within days of the procedure due to the anti-inflammatory properties of the MSCs
• Long term inflammation reduction and cartilage regeneration may occur. Regeneration may take 2-6 months
• If enough cells are isolated, aliquots can be frozen and stored in liquid nitrogen to be thawed for future treatments

Adipose (fat) tissue is collected from the patient

• This is a simple, routine surgical procedure
• It is performed under general anesthesia
• Tissue may be collected from the intra-abdominal or subcutaneous space
• Risks associated with this procedure are similar to any other surgery to remove tissue from the intra-abdominal or SQ space
• Patient recovery is similar to recovery from any other surgery to remove tissue from the intra-abdominal or SQ space
  • Expect 7-14 days of healing and use of an Elizabethan collar, or “head cone”
  • Hair shaving at surgery site
  • Internal or external sutures
  • Pain medications +/- antibiotics

Single dose injection into the pet’s joint by a trained veterinarian (cell product use not validated after 24 hours of receipt)

VCT team member, veterinarian and pet owner collaborate to discuss therapy options, provide product information, organize scheduling, place order, and complete consent documentation

• Consultation with patient, owner & veterinarian available
• In-clinic or online procedural training courses with video instruction available