FDAUpdated Cell Therapy Guidelines and FDA Inspection at Stem Cell Safari
FDA Guidelines Stop Stem Cell Therapy for Dogs in Clinical Practice
Coco received stem cells for IMHA in 2020 and is doing well!Dr. Garner has been treating pets with stem cell therapy for 8 years. Stem Cell Therapy at Safari has evolved from the simple centrifuge-based system that most private veterinarians use to process fat obtained from the patient.
- The centrifuge-based process has the potential to become contaminated as it is processed on a benchtop and not in a biological safety cabinet.
- There is no way to determine the viability of the cells.
- There is no way to determine the number or dose of the cells.
- To give an additional dose, another surgical procedure to remove fat is needed.
- Per the recently updated FDA guidelines, every vet processing autologous fat tissue in-house using the above procedure would need to do so a controlled containment GMP lab from this point forward, which is not feasible.
Because of these limitations, Dr. Garner put himself through school on how to create a laboratory and how to culture, count, and determine the viability of the cells.
- Culturing of cells requires a clean room environment with HEPA filtration, positive air pressure and sterile technique, and biologic safety hood.
- Dr. Garner consulted with InGeneron, a human stem cell laboratory in Houston, about how to set up this lab. He hired only cell technicians trained in stem cell culture techniques to work with the cells.
- Specialized Phase Contrast Microscopes to see live cells while in culture.
- Incubators designed for stem cells.
- Pipette system for feeding cells and sterile disposal of used media.
- Standard media systems for feeding the cells.
- Cell viability stains.
- Automated cell counters.
- Cryopreservation units.
- Specialized Fluorescence Microscopes to determine stem cell type.
- The laboratory processed fat from donors who were already scheduled to have a spay surgery. The fat tissue is collected using sterile and aseptic techniques and transported in sterile containers to the stem cell laboratory for processing.
- The stem cells have been subsequently used on the following critical care pets:
- Paralyzed dogs with Intervertebral Disc Disease (IVDD)
- Critical pets with Immune Mediated Hemolytic Anemia (IMHA)
- Non-responsive cases of Inflammatory Bowel Disease (IBD)
- Cases of Non-responsive Keratoconjunctivitis Sicca (KCS)
- Atopic dermatitis
Former biohazard hood for working with stem cells
Dachshund with neurological issues stemming from IVDD
Jade before, during, and after stem cell therapy for her keratoconjunctivitis sicca (dry eye)
These pets are too sick to undergo surgery for autologous cell therapy.
Pets with non-responsive IBD- Dr. Garner is an ABVP Specialist in Canine and Feline Medicine and Surgery who has recertified every 10 years since 1992.
- Enabling the accurate diagnosis and therapy for these diseases requires special training and equipment so that the stem cells are not administered inappropriately.
- CT Scanner
- MRI Scanner
- Endoscopy
- Arthroscopy
- C-Arm Fluoroscope
Safari MRI, CT, and C-Arm fluoroscopeThis combination of cellular technology, veterinary technology, and surgical skill does not exist elsewhere in veterinary practice. Dr. Garner’s success has spread by word of mouth through internet user groups. As a result, other Veterinary practitioners have asked for access to these stem cells to treat their patients.
Shipment of stem cellsAfter testing the processes for maintaining cell viability while the cells are shipped, Dr. Garner has helped other vets treat some of these critical diseases. But this is only after confirmation of the diagnosis, consulting the medical records, and working with the doctor to treat each patient individually. These 600 or so cases have been followed up and documented for success criteria. Dr. Garner is in the process of publishing these results.
Recently the FDA presented two inspectors to the Safari Stem Cell laboratory. The purpose of their visit was to gather information. This was a 4-day inspection with written recommendations that followed the most recent set of guidelines published by the FDA in 4Q2022.
These guidelines, when applied to the Safari Stem Cell Laboratory, have the following effects:
- Set the Safari Stem Cell Laboratory on par with the requirements of a major pharmaceutical company that for example, might be mass producing a vaccine to the 100,000 or so veterinarians in the United States. This unfairly characterizes Safari who tailors treatments to each individual patient.
- Each dose of cells would be considered a batch that would require culture and lab testing for purity, contamination, cross-contamination, labeling guidelines, shipping guidelines and so on that would make it impossible from a cost or logistics perspective to do in a clinical setting.
- The laboratory would have to be upgraded to cGMP ISO level 7 which would cost about $500,000 for the laboratory and equipment alone.
- This places any clinical veterinarian into a no-win situation.
- Stem cell therapy would not be available to any of these critical patients.
- This may increase the cost of cell therapy well above the budget of the average pet owner.
Stem cell lab when in operation
Daisy was hospitalized for two weeks in 2021, undergoing 12 blood transfusions for IMHA. She was not responding to medications, and was subsequently given 4 rounds of stem cells. Today, she is thriving and her parents are grateful!- Even if the laboratory facilities were obtained and the GMP guidelines adopted, the new FDA guidance considers the expansion of allogenic donor cells to the required therapeutic dose as modification of the cells. According to the FDA inspectors there is no chance of a license to produce this expanded allogenic cell product.
- The FDA considers stem cell therapy of any kind as the use of a manufactured drug.
- This means that even the many veterinarians who use fat derived stem cells would have to “manufacture” them in a clean room under a biosecurity hood, with GMP specifications.
The FDA’s purpose is to protect human lives.
- These stem cell treatments are not for humans.
- These stem cells were used as treatments for companion animals only, and never involved production food animals.
- There is no danger to humans.
- There is however a potential benefit to humans as spinal cord injuries cost society (particularly from motorcycle accidents $7.7 Billion) or intervertebral disc disease ($100 Billion).
- Stem Cells Treat Immune Disease
- Many of the monoclonal antibody therapies could be replaced with stem cell therapies.
- Many of our pets have diseases like humans.
- Lupus, psoriasis, MS, IBD, IMHA and many other diseases can be treated with stem cells that have dog analog diseases.
Safari stem cell lab after voluntarily removing centrifuges, cell incubators, and other key equipment.Safari is committed as always to doing what is best for the pet. Rather than spending hundreds of thousands of dollars to bring our lab up to new specifications, we have decided to close our lab space, terminating expansion of cells and culling our supply of live cells. This was done voluntarily and not due to a directive by the FDA as the FDA’s guidance documents “do not establish legally enforceable responsibilities.” Instead, the recently updated guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations.
Dr Garner still firmly believes that stem cell therapy provides the potential to treat disease that otherwise may not be possible through other means. Therefore, he will be asking for your help as we work with the FDA and The Great State of Texas to pass legislation allowing the continued compassionate care of our furred family members.
