- UK regulatory authority MHRA approves Phase 1 trial with Cymerus(TM) MSCs
- World first clinical trial with allogeneic iPSC-derived product
- Major milestone for stem cell therapeutics and regenerative medicine
- Cements Cynata’s global leadership in second generation MSC therapeutics
How Many Billions Are Spent On Stem Cell Funding? (NIH Spends $1.5B/Year)
Trends in stem cell funding are important to identify because year-over-year changes can alert companies to potential changes in product sales volumes. It is also valuable for life science companies to understand the sources from which their clients derive funding.
Within the U.S., the National Institutes of Health (NIH) had an NIH budget of an estimated $1.495 billion into stem cell research projects in 2016, spanning a wide range of fields from cell biology to electrical engineering.[1]
NIH Budget | Stem Cell Research Funding
In this article:
- The NIH Funding Trend
- California Institute for Regenerative Medicine
- International Stem Cell Research Funding
The NIH Funding Trend
This is an increase from $1.391 billion in (actual) spending by the NIH in 2014 and $1.429 billion in (estimated) spending by the NIH in 2015.
By far, the NIH estimates that its most widely funded sub-category of stem cell research was “Stem Cell Research – Nonembryonic – Non-Human,” with $646 million of estimated funding in 2016.
The NIH’s second best-funded category was “Stem Cell Research – Nonembryonic – Human,” with $457 million estimated in 2016.
The human and non-human embryonic stem cell research was funded at much lower rates.
Only 12.0% of federal stem cell research funding was estimated to be allocated to human embryonic stem cell research in 2016 ($172 million out of $1.436 billion).
This demonstrates the relative lack of support given to human embryonic stem cell research by the U.S. government.
California Institute for Regenerative Medicine
Several state programs made additional contributions to stem cell research projects, the largest being the California Institute of Regenerative Medicine (CIRM).
In 2004, California residents approved a plan to spend $3 billion over a period of 10 years to support stem cell research. Issuance of the bonds needed to finance this venture was initially stalled by legal opposition, but the California Institute for Regenerative Medicine (CIRM), an agency that manages the state’s stem cell program, was able to secure research funds through a loan from the state’s general fund and the sale of “bond anticipation notes” to private investors.[2]
California by itself has already allocated more than $200 million to human embryonic stem cell (hESC) research, making it a major funding source for hESC research.
International Stem Cell Research Funding
Internationally, stem cell research is supported by significant government investments, with Asia being one of the most favorable regions. Additionally, private sources contributed an estimated $1.7 billion dollars of stem cell funding on a global basis during full-year 2015.[3]
Footnotes
[1] Report.nih.gov,. “NIH Categorical Spending -NIH Research Portfolio Online Reporting Tools (Report)”. N.p., 2016. Web. 26 Jan. 2016.
[2] CIRM Provides $40 Million to Support Future Stem Cell Scientists. CA Institute of Regenerative Medicine, Press Release. Available at: http://www.cirm.ca.gov/PressRelease_061809. Accessed Jan 24, 2016.
[2] Stem Cell Research Products – Opportunities, Tools, & Technologies. BioInformant Worldwide, LLC. Available at: http://www.cirm.ca.gov/PressRelease_061809. Accessed Jan 24, 2016.
What do you think about the NIH budget for stem cell research? Share your thoughts in the comments below.
Up Next: Mesoblast & Cartherics to Produce Allogeneic CAR-T Cells from Gene-Edited iPS Cells
Cynata Approved to Launch World’s 1st Clinical Trial with an Allogeneic iPSC-Derived Product
In a major world first, Australian stem cell company Cynata Therapeutics (ASX:CYP) announced it received advice from the UK Medicines and Healthcare products Regulatory Agency (MHRA) that its Phase I clinical trial application has been approved.
The clinical trial has been named “An Open-Label Phase 1 Study to Investigate the Safety and Efficacy of CYP-001 for the Treatment of Adults With Steroid-Resistant Acute Graft Versus Host Disease” (NCT02923375).
It will be the world’s first clinical trial involving a therapeutic product derived from allogeneic (unrelated to the patient) induced pluripotent stem cells (iPSCs).
Highlights of Cynata Therapeutics’ Upcoming Phase 1 Clinical Trial (Protocol Number: CYP-GvHD-P1-01)
Participants for Cynata’s upcoming Phase I clinical trial must be adults who have undergone an allogeneic haematopoietic stem cell transplant (HSCT) to treat a haematological disorder and subsequently been diagnosed with steroid-resistant Grade II-IV GvHD.
The first eight participants will be enrolled in Cohort A and receive two infusions of CYP-001 at a dose of 1 million cells per kilogram of body weight (cells/kg), up to a maximum dose of 100 million cells.
There will be one week between the two CYP-001 infusions in each patient.
The next eight participants will be enrolled into Cohort B and receive two infusions of CYP 001 at a dose of 2 million cells/kg, up to a maximum dose of 200 million cells.
The primary objective of the trial is to assess safety and tolerability, while the secondary objective is to evaluate the efficacy of two infusions of CYP-001 in adults with steroid-resistant GvHD.
Efficacy will be assessed on the basis of response to treatment (as determined by change in GvHD Grade) and overall survival at 28 and 100 days after the administration of the first dose.
Participants will also be followed up for up to two years under a separate non-interventional study protocol.
Importantly, Cynata’s Cymerus™ mesenchymal stem cell (MSC) technology is a second generation process that does not rely on multiple donors or massive expansion of the end product, and therefore, is a commercially viable solution to the manufacture of consistent, robust MSC therapeutic products.
“10 Years of iPSCs” Explores Future Growth as iPSC Field Enters 2nd Decade
To celebrate the decade that has passed since the landmark discovery of induced pluripotent stem cells, Cell Press hosted “10 Years of iPSCs,” a symposium focused on iPSC research and applications. In 2006, Shinya Yamanaka and Kazutoshi Takahashi reported the Nobel Prize winning discovery of induced pluripotent stem cells (iPSCs) in Cell.
Over the past 10 years, iPS cells have become a lab workhorse — providing an unlimited supply of once-inaccessible human tissues with specific genetic mutations for research.
iPSC technology also spurred renewed interest in direct reprogramming across lineages. Progress in understanding the biology of iPSCs and reprogramming has moved in parallel with work on clinical translation to apply the insights obtained, and the first iPSC-based clinical trials are now underway within Japan and launching within the UK.
About “10 Years of iPSCs” by Cell Press
Cell Press is excited to bring together leaders in biology, medicine, and industry to give an up-to-date view of this exciting and rapidly moving area. At this meeting, you can expect to hear about the latest advances in technology development, mechanistic understanding, and therapeutic application of reprogramming for both drug development and cell-based therapy.
The goal of the meeting is to serve as a catalyst for new ideas and future growth as the iPSC and reprogramming field enters its second decade.
Key themes will include:
-
- Mechanisms of reprogramming
- Disease modeling and drug discovery
- Direct reprogramming
- Technology development
- Clinical translation
There will also be a panel on ethical considerations for clinical translation of iPSC research, on Sunday, September 25, 2016, from 17:00-18:00.
Symposium speakers Shinya Yamanaka, George Daley, Christine Mummery, Lorenz Studer, and Deepak Srivastava, and Bioethicist Hank Greely will discuss the most pressing ethics issues facing the field as it moves towards the clinic. Discussion topics will range from the ethics of patient and donor consent in iPSC banking and application to medical use of genome-edited iPSC derivatives and lessons from existing approaches in gene and cell therapy.
Speakers at “10 Years of iPSCs” Symposium
The keynote speakers for the “10 Years of iPSCs” are Shinya Yamanaka (Japan/USA) and Rudolf Jaenisch (USA).
Cesca Therapeutics Granted Two Patents for Rapid Infusion of Autologous Bone Marrow Derived Stem Cells
Technology Fundamental to Cesca’s Proprietary SurgWerks™ Platform for CLI and AMI
RANCHO CORDOVA, Calif., Sept. 19, 2016 (GLOBE NEWSWIRE) — Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today announced that the United States Patent & Trademark Office (USPTO) has granted the Company the first two of a family of patent applications related to Cesca’s proprietary methods for the treatment of ischemic cardiovascular disorders, such as critical limb ischemia (CLI) and acute myocardial infarction (AMI). [Read more…]
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