Within the United States, cord blood banks are subject to U.S. Food & Drug Administration (FDA) and state regulations. The FDA governs all aspects of cord blood preservation, including the collection, processing, storage, labeling, packaging, and distribution of cord blood stem cells. Within the United States, all cord blood banks must be registered with the FDA.
There are two different standards which can apply: cGTP (current Good Tissue Practices) and cGMP (current Good Manufacturing Practices)
cGTP standards apply to the collection, processing, and storage of human cells, tissues, and cellular/tissue based products (HCT/Ps), and are regulated by the Center for Biologics Evaluation and Research. All U.S. cord blood banks must be compliant with cGTP standards.
cGMP standards apply to the manufacturing of a product that is considered a drug, and the determination for whether or not a cord blood bank must be compliant with cGMP standards is based upon the nature of the product that a facility manufactures. Because cGTP standards are based upon cGMP standards, there are many similarities between the two systems.
In the post below, we share with you an introduction to the report content. If you like our coverage of the iPSC industry, then please share this post with your peers who would also benefit from an increased understanding of iPSC market dynamics.
Recent months have seen the first iPSC clinical trial in humans, creation of the world’s largest iPSC biobank, major funding awards, a historic challenge to the “Yamanaka Patent”, a Supreme Court ruling affecting industry patent rights, announcement of an iPSC cellular therapy clinic scheduled to open in 2019, and much more. Furthermore, iPSC patent dominance continues to cluster in specific geographic regions, while clinical trial and scientific publication trends give clear indicators of what may happen in the industry in 2015 and beyond.
Is it worth it to you to get informed about rapidly-evolving market conditions and identify key industry trends that will give you an advantage over your competition?
This global strategic report is produced for:
Management of Stem Cell Product Companies
Management of Stem Cell Therapy Companies
Stem Cell Industry Investors
It is designed to increase your efficiency and effectiveness in:
Commercializing iPSC products, technologies, and therapies
Role of Patent Analysis for Competitive Intelligence
In 2006, groundbreaking experimentation led to the discovery of induced pluripotent stem cells (iPSCs), which are adult cells that are transformed into embryonic-like stem cells through the manipulation of gene expression or other related methods. In 2007, follow-up experiments proved human adult cells could be transformed into iPSC cells. Since the discovery of iPSCs, a large and thriving research product market has grown into existence, largely because the cells are completely non-controversial and can be generated directly from adult cells.
Today, the number of iPSC products sold worldwide is increasing with double-digit growth, and 22% of all stem cell researchers self-report having used iPSCs within a research project. It is clear that iPSCs represent a lucrative product market, but commercializing the cell type involves careful and due diligence, because the cells are still a relatively new discovery.
Because the iPSC industry is a rapidly-evolving area, major research findings and technical discoveries are frequently announced . Therefore, to launch iPSC products and technologies, one of the key areas that company management and investors must consider is the patent landscape for the cell type.
Hematopoietic Stem Cells Transplant Rates, Utilization of Cord Blood, Awareness Rates, and More
The cord blood banking market has emerged gradually over the past 40 years, as 1974 was the first year in which it was proposed that stem and progenitor cells were present in human cord blood. In the forthcoming years it was established that cord blood stem cells had similar properties as bone marrow and could be used as an alternative. Because it is a rich source of highly primitive hematopoietic stem cells, umbilical cord blood has enormous regenerative potential for stem cell based therapy, both for the treatment of hematological and non-hematological disorders. Continue reading If You’re Investing in the Cord Blood Market, You Need to Know These Metrics [Infographic]→
Best Video of 2015: “Birth and Engraftment of Blood Stem Cell”
This video published by the Harvard School of Medicine is incredible! We’ve passed it around and have awarded it the “Stem Cell Video of the Year” award.
It’s a zebrafish animation that shows the discoveries made by the Stem Cell Research Program at Boston Children’s Hospital. Using the zebrafish as a model, it takes you from the birth of a blood stem cell, along its travel through the body, to its site of engraftment.
An incredibly interesting aspect of the stem cell therapy market as it stands today is that autologous stem cell therapies are now being regulated by the U.S. Food and Drug Administration (FDA) as a drug.
Autologous means “from yourself,” and it is really as simple as that. Stem cells, such as hematopoietic stem cells that have been used for decades in bone marrow transplants, can be extracted from an individual, and on the same day, can be re-injected into a specific site that needs repair to optimize health.
Regenexx Stem Cell Procedure
One of the most well-known of these approaches in the Regenexx procedure. You’ll have a very difficult time finding negative press about the procedure from patients that have undergone the procedure, despite that patients have often paid several thousand dollars out-of-pocket to access the care, as it is typically not covered by health insurance carriers in the United States.
The reason for this is that the results can be outstanding. I am an example of a patient whose life was transformed by the procedure. I’m currently working to get access to my own “before” and “after” MRI of my traumatic knee injury that was unable to be address by multiple surgeries and follow-up procedures. I have the “before” MRI, but I need to go have a post-procedure MRI, as I just crossed my one-year mark.
In the meantime, here is a “before” and “after” MRI of another patient’s knee showing positive clinical results from the Regenexx procedure:
How Regulation of Autologous Stem Cell Procedures Affects the Global Stem Cell Market
As a stem cell research firm, the question that interests me most (and the question that will interest most of our readers who are executives at stem cell companies or stem cell industry investors) is how will the current regulation of autologous stem cells as a “drug” affect the broader stem cell marketplace?
If regulations in the United States that treat autologous stem cell as a drug do not change, then other countries, most notably Japan and Canada, but also United Kingdom, Australia, and others, will soon outpace the U.S. in this area of applied medicine. Furthermore, for-profit companies in the U.S. will not have financial incentives to invest in the development of autologous stem cell treatments.
For the stem cell market at large, continued regulation of autologous stem cells as drugs in the U.S. will cause more money to flow overseas, followed by more jobs, more talent, and more future stem cell research advances. Without regulatory change, the epicenter of the stem cell market will not be the United States for much longer, if it even is now. Japan is moving forward rapidly with stem cell based cellular therapy development, and may already have out-paced the U.S.
Are Stem Cells Different than Current Surgical Tissue Grafts?
As “food for thought” on this subject of autologous stem cell regulation, an important question to consider is whether the use of autologous stem cells for therapeutic purposes should be considered as substantially different than currently allowed surgical procedures. For instance, in many surgical procedures, including traditional approaches to ACL repair, a graft is taken from another site of a patient’s body and placed into a new location. In the example of traditional approaches to ACL repair, this procedure is known as “Hamstring Tendon Graft Reconstruction” of the ACL.
Is a stem cell that has originated in you a drug, or you do and your doctor have a right to use it for therapeutic purposes?
Is moving stem cells from one site to another any different than surgically using other patient grafts or tissues?
“Special” and “Designer” Stem Cells
Naturally, there are different types of stem cells, and some come with greater complications and risks than others. For instance, there might be greater value in the regulation of stem cells that are sourced from another individual, a procedure known as an “allogenic” stem cell transplant. (“Allogenic” means coming from another.)
There are also embryonic stem cells (ESCs), which must be derived from embryos at fertility clinics. Note that these same embryos used to derive ESCs would be discarded or die if they were not used to derive ESCs, because embryos cannot be indefinitely preserved. It is no more possible for an embryo to life indefinitely than it is for a full-grown person to live forever.
There are also induced pluripotent stem cells, which are adult cells that are reverse engineered to be pluripotent in nature, allowing them to have the potential to become a diverse range of adult cell types. Functionally, they are quite similar to embryonic stem cells in their therapeutic potential.
However, these “special” and “designer” stem cell types must not be compared to the basic hematopoietic stem cells that travel throughout an adult body, highly concentrated in specific regions such as the bone marrow. These autologous stem cells are intrinsic to every living being.
For that reason, I leave you today’s powerful quote, not as an answer, but as fuel for intellectual curiosity:
Note: Click to enlarge image.
Enjoy, comment, in get in on this discussion of how autologous (“self”) stem cells should or should not be regulated!
Future Posts about the Stem Cell Industry
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BioInformant is the only research firm that has served the stem cell sector since it emerged. Our management team comes from a BioInformatics background – the science of collecting and analyzing complex genetic codes – and applies these techniques to the field of market research. BioInformant has been featured on news outlets including the Wall Street Journal, Nature Biotechnology, CBS News, Medical Ethics, and the Center for BioNetworking.
Serving Fortune 500 leaders that include GE Healthcare, Pfizer, Goldman Sachs, Beckton Dickinson, and Thermo Fisher Scientific, BioInformant is your global leader in stem cell industry data. To learn more about emerging opportunities and threats within the stem cell market, view our global strategic reports for the stem cell industry.
Although we are only a few months in 2015, the cord blood banking market has already been experiencing rapid change.
The industry has seen structural advances occur, including a recent announcement of the Board of Directors for the Cord Blood Association, an international nonprofit that promotes the storage and use of cord blood and related tissues, such as cord tissue and placenta.
There have been major research advances as well. In one major example, a porcine animal study was conducted by the Mayo Clinic to evaluate the safety and feasibility of cord blood-derived mononuclear cells (UBC-MNC) for use in promoting regeneration in pediatric congenital heart disease (CHD).
There have even been major clinical advances made already in 2015, with CryoSave leading and sponsoring a multicentre clinical trial following GCP-ICH standards, to determine if Cerebral Palsy can be addressed by infusing stem cells derived from umbilical cord blood and cord tissue into patients.
However, no understanding of the cord blood market is complete without a consideration of recent case law and significant legal decisions, which brings us to the focus on this market update.
MarketResearch.com has posted an article titled, “4 Key Metrics You Need to Know to Invest in the Cord Blood Sector,” featuring BioInformant’s analytics for the cord blood banking market.
An excerpt is included below:
“If you are an investor considering an opportunity within the cord blood market, the market can initially appear technical and confusing. However, if you focus on four key metrics, you can quickly and easily assess the technical attributes that matter, including market size, market potential, market competition, and market growth rates.”
A trusted business partner of ours, MarketResearch.com has been selected by Inc. 5000 Magazine as one of America’s fastest growing private companies.
BioInformant is excited to share that our induced pluripotent stem cell industry analytics have been featured on the “Signals Blog,” published by the Centre for Commercialization of Regenerative Medicine (CCRM). CCRM is a Canadian, not-for-profit organization supporting the development of foundational technologies that accelerate the commercialization of stem cell- and biomaterials-based products and therapies.