Dear Colleagues,
The International Perinatal Stem Cell Society, Inc. (Perinatal Society), a 501(c)3 non-profit organization, was established in 2013 with the primary objective of facilitating patient access to safe, affordable, and efficacious perinatal-derived stem cell treatments in the United States. Perinatal stem cell sources include amnion, amniotic fluid, cord blood, cord tissue/Wharton's jelly, placental blood, and placental tissue. These stem cells, formed around the time of and possess great therapeutic potential.
Over the years, we have hosted 10 international scientific congresses, featuring world-class and influential faculty members. At these conferences, we listened to patients' requests for immediate access to perinatal stem cell and tissue treatments. We also featured FDA representatives and held regulatory panels aimed at collaborating with the FDA to accelerate access to stem cell therapy. We have edited three seminal textbooks on perinatal stem cells and continue to contribute to the growing knowledge in this field through scientific chapter contributions.
In 2013, perinatal stem cells were an overlooked topic at the stem cell conferences which instead focused on iPSCs and adult stem cells from bone marrow and adipose tissue and ignored the perinatal sources. We stated that our initial success for our organization would be when the other stem cell conferences and organizations added perinatal stem cells to their agendas which is what happened overtime. Today, perinatal stem cells are widely studied and used therapeutically around the globe.
The Perinatal Society and our members continue to reshape the field and enable access to lifesaving and life-changing stem cell therapies. This letter serves to update you on our progress and share our next steps in accomplishing our updated goal of changing the stem cell regulatory landscape in the United States.
Proposed Perinatal Stem Cell Bill:
In 2014, the Japanese Government passed the Regenerative Medicine Act creating a regulatory system that benefits both patients and companies. The Perinatal Society advocates for a bill that mirrors the Japanese Regenerative Medicine Act, which recognizes the need for a different regulatory approach for stem cells than small molecule drug development. This framework allows patients to gain access to stem cell therapy by creating a system that enables companies to successfully navigate the regulatory approval process and gain market approval while maintaining strict quality oversight.
Under the proposed bill, companies sponsor a Phase I safety trial to prove the safety and potential efficacy of the stem cell therapy. Once the Phase I trial is complete, companies continue with Phase II and III trials, but patients pay to participate in the trial. In Japan, national health insurance reimburses at competitive rates for the Phase II and III study participants. This approach provides funding for the later clinical trials and helps bridge the "Valley of Death" which is a period between a successful Phase I trial and a Phase III trial where funding dries up prior to market approval.
The Perinatal Society advocates for pooling safety data from similar stem cell preparations in the new bill. If a product is from the same source and manufactured in a similar manner safety data could be pooled. This would allow companies to bypass repeated Phase I safety studies for perinatal stem cell products that have already demonstrated safety. This will create more studies for patients to join that are in later Phase II trials that test for efficacy in specific indications.
There are many patients that would fiscally sponsor their own treatment in the Phase II and Phase III clinical trials. There exists a steady stream of US citizens that are paying offshore stem cell clinics for similar stem cell therapies and often times are enjoying great benefit from the therapies. However, I am sure the best hospitals and labs in the US could match or surpass the quality of the stem cell products made in the offshore labs. Although the clinical trial is funded by paying patients, once the clinical trial is complete and market approval is granted, US health insurance should cover the cost for patients to be treated by the approved stem cell product.
Manufacturers:
The Perinatal Society understands the challenges faced by manufacturers of perinatal stem cell and tissue products. To address these challenges, we have created a Manufacturing Committee that provides a venue for manufacturers to collaborate and advance the field. The committee aims to support manufacturers' needs and provide an independent voice for Manufacturers. The Perinatal Society is proud to speak for the manufacturers without fear of repercussions from the FDA. Joining the Manufacturing Committee requires financial support to the Perinatal Society to participate. Reach out to Kyle Cetrulo at [email protected] to learn more.
Improving the Utah State Bill:
While the recently passed Utah bill is a step forward in providing access to perinatal stem cell and tissue therapy, it fails to address several concerns regarding patient safety. The Perinatal Society stresses the importance of safe stem cell therapy and believes it is crucial to address the high-risk areas not covered in the Utah bill.
In collaboration with the Perinatal Manufacturing Committee, we are defining and classifying various perinatal stem cell and tissue products. Once a universal set of product classifications and characteristics is established, the Perinatal Society will offer product certification and enable third-party independent analysis of available products. The Society's website and newsletter will provide company-agnostic instructions for use and treatment protocols, ensuring practitioners have access to reliable educational materials.
The Perinatal Society will also launch online training programs and in-person hands-on training sessions to address the gap in practitioner certification mentioned in the Utah bill. We acknowledge the existing state of the field and are hoping that these efforts will help to keep patients safe while maintaining access to the highest quality stem cell and tissue products possible at this time under the current regulatory framework. We believe strongly that the structure of the Perinatal USA bill we propose will provide the safest access to the best stem cell and tissue products once it is enacted into law in the United States.
Tracking Treatment Outcomes and Adverse Events:
It is crucial for the perinatal stem cell field to create a universal data registry to track treatment outcomes and adverse events. The Perinatal Society believes that a universal data collection system is one of the most important areas for the field to focus on to demonstrate the safety of perinatal stem cell and tissue products. And to immediately stop any actions or products that cause harm. Sharing this data openly is critical.
Patient Advocacy
The Perinatal Society views its role as supporting patients and enabling access to safe and effective stem cell treatments. We believe that stem cell therapy should be a fundamental patient right for all U.S. citizens. We are developing a platform for patients to share their success stories and connecting with patient advocacy groups and foundations across the United States to amplify the need for regulatory framework change. Once the Perinatal USA bill is law, we will work to connect patients to stem cell studies under the bill.
Financial Support and Volunteer Efforts:
We welcome financial support through our website donation portal. www.perinatalstemcells.com
The Perinatal Society has created volunteer committees for various areas, including Legislation/Draft Bill, Social Media/Blog Post, Patient Advocacy Outreach, Distributor Ethics, Data Collection, and a Manufacturing Committee.
We invite anyone interested in contributing to our cause to reach out to [email protected] to discuss the best role for themselves within the Society.
We are stronger when we work together as a cohesive industry.
Sincerely,
Kyle Cetrulo
President
The International Perinatal Stem Cell Society, Inc.
[email protected]
The International Perinatal Stem Cell Society, Inc. (Perinatal Society), a 501(c)3 non-profit organization, was established in 2013 with the primary objective of facilitating patient access to safe, affordable, and efficacious perinatal-derived stem cell treatments in the United States. Perinatal stem cell sources include amnion, amniotic fluid, cord blood, cord tissue/Wharton's jelly, placental blood, and placental tissue. These stem cells, formed around the time of and possess great therapeutic potential.
Over the years, we have hosted 10 international scientific congresses, featuring world-class and influential faculty members. At these conferences, we listened to patients' requests for immediate access to perinatal stem cell and tissue treatments. We also featured FDA representatives and held regulatory panels aimed at collaborating with the FDA to accelerate access to stem cell therapy. We have edited three seminal textbooks on perinatal stem cells and continue to contribute to the growing knowledge in this field through scientific chapter contributions.
In 2013, perinatal stem cells were an overlooked topic at the stem cell conferences which instead focused on iPSCs and adult stem cells from bone marrow and adipose tissue and ignored the perinatal sources. We stated that our initial success for our organization would be when the other stem cell conferences and organizations added perinatal stem cells to their agendas which is what happened overtime. Today, perinatal stem cells are widely studied and used therapeutically around the globe.
The Perinatal Society and our members continue to reshape the field and enable access to lifesaving and life-changing stem cell therapies. This letter serves to update you on our progress and share our next steps in accomplishing our updated goal of changing the stem cell regulatory landscape in the United States.
Proposed Perinatal Stem Cell Bill:
In 2014, the Japanese Government passed the Regenerative Medicine Act creating a regulatory system that benefits both patients and companies. The Perinatal Society advocates for a bill that mirrors the Japanese Regenerative Medicine Act, which recognizes the need for a different regulatory approach for stem cells than small molecule drug development. This framework allows patients to gain access to stem cell therapy by creating a system that enables companies to successfully navigate the regulatory approval process and gain market approval while maintaining strict quality oversight.
Under the proposed bill, companies sponsor a Phase I safety trial to prove the safety and potential efficacy of the stem cell therapy. Once the Phase I trial is complete, companies continue with Phase II and III trials, but patients pay to participate in the trial. In Japan, national health insurance reimburses at competitive rates for the Phase II and III study participants. This approach provides funding for the later clinical trials and helps bridge the "Valley of Death" which is a period between a successful Phase I trial and a Phase III trial where funding dries up prior to market approval.
The Perinatal Society advocates for pooling safety data from similar stem cell preparations in the new bill. If a product is from the same source and manufactured in a similar manner safety data could be pooled. This would allow companies to bypass repeated Phase I safety studies for perinatal stem cell products that have already demonstrated safety. This will create more studies for patients to join that are in later Phase II trials that test for efficacy in specific indications.
There are many patients that would fiscally sponsor their own treatment in the Phase II and Phase III clinical trials. There exists a steady stream of US citizens that are paying offshore stem cell clinics for similar stem cell therapies and often times are enjoying great benefit from the therapies. However, I am sure the best hospitals and labs in the US could match or surpass the quality of the stem cell products made in the offshore labs. Although the clinical trial is funded by paying patients, once the clinical trial is complete and market approval is granted, US health insurance should cover the cost for patients to be treated by the approved stem cell product.
Manufacturers:
The Perinatal Society understands the challenges faced by manufacturers of perinatal stem cell and tissue products. To address these challenges, we have created a Manufacturing Committee that provides a venue for manufacturers to collaborate and advance the field. The committee aims to support manufacturers' needs and provide an independent voice for Manufacturers. The Perinatal Society is proud to speak for the manufacturers without fear of repercussions from the FDA. Joining the Manufacturing Committee requires financial support to the Perinatal Society to participate. Reach out to Kyle Cetrulo at [email protected] to learn more.
Improving the Utah State Bill:
While the recently passed Utah bill is a step forward in providing access to perinatal stem cell and tissue therapy, it fails to address several concerns regarding patient safety. The Perinatal Society stresses the importance of safe stem cell therapy and believes it is crucial to address the high-risk areas not covered in the Utah bill.
In collaboration with the Perinatal Manufacturing Committee, we are defining and classifying various perinatal stem cell and tissue products. Once a universal set of product classifications and characteristics is established, the Perinatal Society will offer product certification and enable third-party independent analysis of available products. The Society's website and newsletter will provide company-agnostic instructions for use and treatment protocols, ensuring practitioners have access to reliable educational materials.
The Perinatal Society will also launch online training programs and in-person hands-on training sessions to address the gap in practitioner certification mentioned in the Utah bill. We acknowledge the existing state of the field and are hoping that these efforts will help to keep patients safe while maintaining access to the highest quality stem cell and tissue products possible at this time under the current regulatory framework. We believe strongly that the structure of the Perinatal USA bill we propose will provide the safest access to the best stem cell and tissue products once it is enacted into law in the United States.
Tracking Treatment Outcomes and Adverse Events:
It is crucial for the perinatal stem cell field to create a universal data registry to track treatment outcomes and adverse events. The Perinatal Society believes that a universal data collection system is one of the most important areas for the field to focus on to demonstrate the safety of perinatal stem cell and tissue products. And to immediately stop any actions or products that cause harm. Sharing this data openly is critical.
Patient Advocacy
The Perinatal Society views its role as supporting patients and enabling access to safe and effective stem cell treatments. We believe that stem cell therapy should be a fundamental patient right for all U.S. citizens. We are developing a platform for patients to share their success stories and connecting with patient advocacy groups and foundations across the United States to amplify the need for regulatory framework change. Once the Perinatal USA bill is law, we will work to connect patients to stem cell studies under the bill.
Financial Support and Volunteer Efforts:
We welcome financial support through our website donation portal. www.perinatalstemcells.com
The Perinatal Society has created volunteer committees for various areas, including Legislation/Draft Bill, Social Media/Blog Post, Patient Advocacy Outreach, Distributor Ethics, Data Collection, and a Manufacturing Committee.
We invite anyone interested in contributing to our cause to reach out to [email protected] to discuss the best role for themselves within the Society.
We are stronger when we work together as a cohesive industry.
Sincerely,
Kyle Cetrulo
President
The International Perinatal Stem Cell Society, Inc.
[email protected]
