The Perinatal Stem Cell Society was founded on the basic principle that stem cells from perinatal tissues contain enormous, untapped potential for use in medicine. For this reason, the society hosts an annual event known as the Perinatal Stem Cell Society Congress. It includes a scientific program with topics covering all aspects of the perinatal stem cell field, with attendees advancing perinatal stem cell research and focused on paths towards treatment.
Without question, perinatal stem cells represent one of the most promising areas of stem cell research. While perinatal stem cells are largely recognized for their therapeutic potential, these cells will also shape the fields of drug discovery and toxicology.
For this reason, I am honored to share an interview below with Kyle Cetrulo, President and Founder of the Perinatal Stem Cell Society.
Interview with Kyle Cetrulo of the Perinatal Stem Cell Society
Cade Hildreth: Hi Kyle, I am excited to talk to you about this year’s Perinatal Stem Cell Society Congress and about the space at large.
My first question is, what types of perinatal tissues will be discussed at this years event and what indications will be emphasized?
Kyle Cetrulo: Thanks for taking the time to interview me. The event is taking place March 1st and 2nd in Salt Lake City and as a Perinatal Society, we try to include all the perinatal tissues – the placenta, the cord tissue, the cord blood, and the amnion. This year, we also have a number of talks focused on the secretome, exosomes from the Wharton’s jelly, and cell products themselves.
From a cord blood perspective, we will be focusing on cutting-edge clinical applications, such as treating cerebral palsy, autism, and other difficult to treat conditions. We have a great talk by Dr. Timothy Nelson from the Mayo Clinic about his use of autologous cord blood for addressing congenital heart disease, which is a fascinating topic. His group uses this approach with preterm babies, collecting cord blood while the child is in utero and using it to correct heart defects, which is amazing science.
Cade Hildreth: Amazing to hear. I know Dr. Nelson, because my sister has a congenital heart condition and had open-heart surgery at the Mayo Clinic about 18 months ago.
Kyle Cetrulo: Yes, Dr. Nelson is an important leader in the field and the Mayo Clinic is one of the best sites in the world for surgical care. Those are the cord blood topics, but we also have a lot of cord tissue products that are being discussed, mostly 361 as well as some 351 regulatory products, which are expanded cord tissue products. Additionally, we have a few overviews of the entire field. One will be provided by Dr. Francis Verter from the Parent’s Guide to Cord Blood. She will be giving an overview of the current clinical trial landscape.
We also have the incoming President to the National Marrow Donor Program (NMDP), Dr. Andrew Mills giving an overview of what the NMDP plans to do to improve the field through the use of cellular therapy, with an emphasis on cord blood and perinatal products. So, we will cover the whole spectrum of perinatal products and perinatal stem cell types. For anyone interested in this space, there will be someone for them.
We do have some placental focused talks as well. Dr. Bob Hariri who is one of, if not the foremost placental blood and placental tissue scientist in the world, will be presenting his work as a platform for longevity using placental stem cells. His newest company, Celularity, launched last week with an astonishing $250 million in funding.
Cade Hildreth: I am glad you mentioned Dr. Hariri. I released an interview with Bob last week about this achievement. With what is occurring today with perinatal tissues and how is it differing from the past?
Kyle Cetrulo: We have seen a number of the results coming in from the early clinical trials, particularly in the cord blood space with the cord blood cerebral palsy the work that Dr. Kurtzberg has been doing at Duke University. She is going to be presenting that work again at our meeting.
Also, the 361 space is developing substantially, so patient data will be presented that shows that these cells really do have a positive effect, particularly on musculoskeletal indications. Indications themselves won’t be talked about from 361 companies, but they will be presenting the overall spectrum of how these products are being used by doctors under the practice of medicine.
Cade Hildreth: Fantastic. In what ways are you structuring this year’s Perinatal Stem Cell Society Congress to be different than past events?
Kyle Cetrulo: You know, what we are really trying to do, is to go back to our roots. Our most successful meeting was our 2016 meeting in Aspen, Colorado, which was a great meeting, a hardcore perinatal meeting of industry researchers. We also want to put everyone on a site that is a really great place where they want to stick around, eat excellent food, and have great networking sessions. That’s what we are gearing to do again, so we rented the 3rd floor of a really cool museum in Salt Lake City.
We are going to have a theater with theater style seats and the exhibitors are part of the program, so we reserved the entire third floor of this museum, called the Leonardo (which is a sort of a Leonardo Da Vinci themed museum). It is a hybrid between a science museum and a children’s museum, and the floor we have rented is a genuinely beautiful space. They hold weddings and events there, so it is a unique venue for a stem cell meeting, which I think people will really appreciate.
It will also be an incredible networking opportunity, and then obviously the level of science that will be presented from the faculty in the lectures is what really drives the event. It doesn’t hurt that we are going to have a nice cocktail party, dinner, excellent food and a great opportunity for people to sit down in a quiet area and have private meetings as well. This will facilitate the flow of exchange, which is very important for conferences. Past meetings have been successful and we have kind of found what works best at our meetings and we are trying to bring those elements to the forefront.
Finally, on Saturday, anyone who is sticking around can go skiing. We will be organizing that as well, where people can do some runs and network on chair lifts and in the chalet.
Cade Hildreth: Sounds like a phenomenal event from start to finish.
Kyle Cetrulo: You know, we haven’t seen that many stem cell networking events on chairlifts…
Cade Hildreth: You can’t get away from each other, so it’s perfect!
Kyle Cetrulo: Exactly. 15 minutes of someone’s attention!
Cade Hildreth: How has the FDA’s position on cell therapies affected the perinatal stem cell space?
Kyle Cetrulo: I think it has affected the entire regenerative medicine space significantly. The guidance documents that were finalized for minimal manipulation and homologous use I think have had a positive effect on the 361 space, for sure. At least there’s a road map that we can reference now as opposed to just being on a cliff and saying, ‘What’s coming next?” Prior to the release of these documents, no one really knew what to expect.
The documents are finalized, so market participants now know how they are supposed to play. I do think things have gotten more difficult for the amnion products, with the FDA limiting the scope for which amnion products can now be used used. The FDA also drastically limited the scope of what adipose products could be used for as well.
So, I think those fields took kind of a big hit, but in general I think it’s really positive from an industry perspective to know what the rules are. Even if we don’t agree with all the rules, at least we know what they are now, so companies can go to investors and present a plan to work within a legal structure to sell 361 products and that is a lot better than saying “this could change in a moment’s notice” and having that cloud over the industry.
Now, we also have 36 months to adapt and to restructure programs, so if companies are slightly out of bounds from the guidance documents released by the FDA, they can come back into bounds. The FDA, I have heard, is very open to working with companies that are attempting to go down the right path, to help bring them in line. The industry is a little more stable now, I would say , even though it might be tighter for what can and cant be done.
At least there is a program that can be followed and a roadmap. This is hugely beneficial, because you can strategize and you can plan, and you can develop products that would fit into 361 classification. Alternatively, if you can now scrap projects that you know will be 351 products. Or, you can plan to develop under a 351 paradigm.
At least we now know what we are starting from the beginning, rather than making that decision and going 5 years into it and then getting the rug pulled out from under you by a change in FDA regulation. That is a positive development for the field, and honestly I think that as a field, people are more susceptible to go and work with the FDA, because they view it as partner, rather than an adversary at this stage.
That is the message that people are hearing form these talks with the FDA. The FDA wants to get stem cell therapies to people and they want the industry to help them do it.
At the same time, as a society – The Perinatal Stem Cell Society – is convening a working group to develop voluntary standards for the 361 fields. We have a number of different people who have joined this working group, because we don’t want to end up where the adipose industry ended up. What happened there was a few really, really rogue characters that tainted the entire field and the FDA came down hard on the entire field, because that was the only way to reel in the “bad cowboys.” Even though all those people who got warning letters are still selling products and still operating, the whole adipose field is struggling.
As a perinatal community, there is enough of a maturity here that we want to self-police, or at least come up with quality products that will make it even easier for the FDA to say, “If these other guys aren’t even working within these voluntary industry standards, let’s help the groups who are trying to follow the rules to a high standard.”
From that working group, we have also contacted a number of different FDA standards organizations, to help develop our voluntary standards, and then help advise the FDA on what would be applicable standards for them to make the official standards. That’s something of an initiative that the society has taken on. We have a public meeting at our congress. Anyone who attends the conference is welcome to attend, listen, and potentially join the working group.
Cade Hildreth: Final question, what’s the history of the perinatal stem cell society and how did it form? How did you get involved?
Kyle Cetrulo: I was the founder along with Dr. Rouzbeh Taghizadeh and Dr. Sean Murphy. We previously edited some books call Perinatal Stem Cells and we are on our fourth version of Perinatal Stem Cells, which is hopefully coming out in the spring/summer. We have all the authors chapters submitted and it’s with the publisher right now.
What would happen is, we would form these networks of authors who would write these awesome or brilliant chapters on the theme of perinatal stem cells and we would do all this work to put the book together. Then, the book would come out and the work would just fade away. We decided that we should really keep the momentum going from those books and form a society and have annual meetings, because the science actually moves faster than the publishers can. To do this, we formed into a society as an outcropping of publishing these perinatal books together.
What is really interesting is that in conjunction with Dr. Anthony Atala from Lake Forest, we did two perinatal books and he also wrote chapters for our books. He published a perinatal book and we wrote a chapter for his book. Then, after the fourth one, we decided to collaborate. So, we are doing our fourth perinatal book where he is the lead editor and he brought in his expertise and his network of authors and we brought in ours and we have combined to create the ultimate perinatal book, which we are working on together.
Cade Hildreth: I am excited for this year’s event. I appreciate your insights on it, and I look forward to seeing you in Salt Lake City on March 1st and 2nd.
Kyle Cetrulo: And skiing on the Saturday!
Cade Hildreth: And skiing on the 3rd. See you soon in Salt Lake!
For members of the BioInformant community, use the code “BIOI” to get $100 off your registration and I look forward to seeing you there.