Regenerative Medicine Can Help Make America Great – Morning Consult

When President Donald Trump urged the biopharmaceutical industry to reduce the price of new medicines and to increase its manufacturing in the United States, many took it as a threat.

We believe its a call to action. Americas ingenuity in biomedical research is unsurpassed. However, our country is losing out to other nations in the fastest growing biotechnology sector, called regenerative medicine: harnessing the capacity of our cells to repair and restore health and sustain well-being.

Second place is not an option. The regenerative medicine market is growing about 21 percent a year and is expected to be worth over $350 billion by 2050. Today, the U.S. regenerative medicine sector is generating $3.6 billion in revenues and has produced 14,000 jobs. By 2050, the industry could create nearly a million new jobs nationwide.

Regenerative medicine will also reduce the cost of disease. Such therapies will replace drugs, devices, and surgery, saving lives, increasing productivity, and reducing the cost of care. This transformation will add trillions in value to our economy.

Finally, regenerative medicine will also make America more secure. Our nation still lacks the ability to quickly and cheaply mass produce vaccines, antidotes, and cell therapies to counter pandemics and bioterrorism. Our fighting forces need reliable sources of these countermeasures and deserve immediate access to treatments that give them back their lives. We shouldnt outsource the safety and well-being of our nation and our Armed Forces to other countries.

To regain leadership in regenerative medicine, U.S. firms dont need government loans, tax credits or massive de-regulation. Instead, it needs the opportunity to invest in reducing the time and cost of manufacturing cellular therapies. To the extent that regenerative medicine is curative it must be made available at vaccine like prices. At present, only a handful of people can afford such treatments.

China and Japan are now in forefront of reducing the cost of producing stem cells, tissue, and other products with restorative biological properties. As a result, they are attracting more capital and forming more new companies than the U.S.

In 2014 Japan became the first country in the world to adopt an expedited approval system specifically for regenerative medical products and to allow outsourced cell culturing. Two products were approved under the new system within a year of its adoption.

By contrast, the Food and Drug Administration regulates any use of manufactured stem cells as equally risky without regard to prior use, health benefit, or therapeutic potential. Indeed, many of the most common stem cell therapies including bone marrow transplants and blood transfusions would require 10 years of FDA review if they were brought to market today.

The problem isnt over-regulation. Its outdated regulation. Safety checks and benchmarks for cell manufacturing should be based on real world evidence of past applications. Regulation should focus on the specific potential side effects for each specific potential use. In this regard, we agree with incoming FDA Commissioner Scott Gottlieb, who has noted, Expediting the development of these novel and transformative technologies like gene- and cell-based therapies doesnt necessarily mean lowering the standard for approval, as I believe other countries have done. But it does mean having a framework thats crafted to deal with the unique hypothetical risks that these products pose.

In fact, the United States has the best regenerative medicine manufacturing technology in the world. But it is literally sitting unused in warehouses.

For example, under the Accelerated Manufacture of Pharmaceuticals program, private companies partnered with the Defense Advanced Research Projects Agency to develop mobile cell and tissue manufacturing plants that can be set up almost anywhere. The facilities can produce cells and tissues at a fraction of the current cost. These mobile factories make real-time production of vaccines and biologics for potential bioterrorist threats and pandemics possible. They are also low-cost, high-tech platforms for experimental evaluation of any type of regenerative medicine.

AMPs are operating in Indonesia, Singapore, China, and Japan where cell products including vaccines are being mass produced. Not a single AMP is being used in the United States because of outdated regulations.

To remove this regulatory obstacle, the Trump administration should establish a separate regenerative medicine pathway. This pathway, which could be developed by DARPA, FDA, and the Centers for Disease Control and Prevention, would develop regulatory standards for the safe manufacturing and testing of development of regenerative products to treat battlefield related traumas such as traumatic brain injury, life-threatening limb damage, and drug-resistant pathogens.

The focus on the conditions and circumstances unique to war or counter-terrorism is both appropriate and strategic. After World War II, Franklin Roosevelt directed that the scientific and entrepreneurial talents used to achieve ramp up war-time production of penicillin and blood plasma be used in the days of peace ahead for the improvement of the national health, the creation of new enterprises bringing new jobs, and the betterment of the national standard of living.

What was created exceeded that vision. The cooperative efforts to achieve mass production of penicillin and blood plasma inspired and supported the creation of industries that employ millions of people today.

Similarly,developing an affordable source of cell therapies to heal our fighting forces and protect the homeland will yield a wide array of affordable technologies and cures that will produce, in FDRs words, a fuller and more fruitful employment and a fuller and more fruitful life. Simply put, by making the manufacture of regenerative medicine affordable can help make America great.

Robert Hariri is CEO of Celularity. Robert Goldberg is vice president of Center for Medicine in the Public Interest.

Morning Consult welcomes op-ed submissions on policy, politics and business strategy in our coverage areas. Updated submission guidelines can be foundhere.

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Mitochondria Behind Blood Cell Formation – Northwestern University NewsCenter

Mitochondria are tiny, free-floating organelles inside cells. New Northwestern Medicine research has discovered that they play an important role in hematopoiesis, the bodys process for creating new blood cells.

New Northwestern Medicine research published in Nature Cell Biology has shown that mitochondria, traditionally known for their role creating energy in cells, also play animportant role in hematopoiesis, the bodys process for creating new blood cells.

Historically, mitochondria are viewed as ATP energy producing organelles, explained principal investigator Navdeep Chandel, PhD,the David W. Cugell Professor ofMedicinein the Division ofPulmonary and Critical Care Medicine. Previously, my laboratory provided evidence that mitochondria can dictate cell function or fate independent of ATP production.We established the idea that mitochondria are signaling organelles.

In the currentstudy, Chandels team, including post-doctoral fellow Elena Ans, PhD, and graduate students Sam Weinberg and Lauren Diebold, demonstrated that mitochondria control hematopoietic stem cell fate by preventing the generation of a metabolite called 2-hydroxyglutarate (2HG). The scientists showed that mice with stem cells deficient in mitochondrial function cannot generate blood cells due to elevated levels of 2HG, which causes histone and DNA hyper-methylation.

This is a great example of two laboratories complementing their expertise to work on a project, said Chandel, also a professor ofCell and Molecular Biologyand a member of theRobert H. Lurie Comprehensive Cancer Center of Northwestern University.

Sam Weinberg, a graduate student in the Medical Scientist Training Program, and Lauren Diebold, a graduate student in the Driskill Graduate Program in Life Sciences, were co-authors on the paper.

Paul Schumacker, PhD, professor of Pediatrics, Cell and Molecular Biology and Medicine, was also a co-author on the paper.

Chandel co-authored an accompanying paper in Nature Cell Biology, led by Jian Xu, PhD, at the University of Texas Southwestern Medical Center, which demonstrated that initiation of erythropoiesis, the production of red blood cells specifically, requires functional mitochondria.

These two studies collectively support the idea that metabolism dictates stem cell fate, which is a rapidly evolving subject matter, said Chandel, who recently wrote a review in Nature Cell Biology highlighting this idea. An important implication of this work is that diseases linked to mitochondrial dysfunction like neurodegeneration or normal aging process might be due to elevation in metabolites like 2HG.

This research was supported by National Institutes of Health grants R35CA197532, T32GM008061, T32 T32HL076139, K01DK093543 and R01DK111430, and Cancer Prevention and Research Institute of Texas New Investigator award RR140025.

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Inflammatory molecule essential to muscle regeneration in mice – Stanford Medical Center Report

Prostaglandin E2, or PGE2, is a metabolite produced by immune cells that infiltrate the muscle fiber as well by the muscle tissue itself in response to injury. Anti-inflammatory treatments have been shown to adversely affect muscle recovery, but because they affect many different pathways, its been tough to identify who the real players are in muscle regeneration.

Ho and Palla discovered a role for PGE2 in muscle repair by noting that its receptor was expressed at higher levels on stem cells shortly after injury. They found that muscle stem cells that had undergone injury displayed an increase in the expression of a gene encoding for a receptor called EP4, which binds to PGE2. Furthermore, they showed that the levels of PGE2 in the muscle tissue increased dramatically within a three-day period after injury, indicating it is a transient, naturally occurring immune modulator.

To determine its mechanism of action, Ho and Palla created a genetically engineered strain of laboratory mice that allowed them to dynamically monitor the number and activities of muscle stem cells over time. They then studied how the stem cells responded to leg muscle injuries caused by injection of a toxin or by application of cold temperatures. (The mice were anesthetized during the procedure and given pain relief during recovery.)

This transient pulse of PGE2 is a natural response to injury, said Blau. When we tested the effect of a one-day exposure to PGE2 on muscle stem cells growing in culture, we saw a profound effect on the proliferation of the cells. One week after a single one-day exposure, the number of cells had increased sixfold compared with controls.

After seeing what happened in laboratory-grown cells, Ho and Palla tested the effect of a single injection of PGE2 into the legs of the mice after injury.

When we gave mice a single shot of PGE2 directly to the muscle, it robustly affected muscle regeneration and even increased strength, said Palla. Conversely, if we inhibited the ability of the muscle stem cells to respond to naturally produced PGE2 by blocking the expression of EP4 or by giving them a single dose of a nonsteroidal anti-inflammatory drug to suppress PGE2 production, the acquisition of strength was impeded.

We are excited about this finding because it is counterintuitive, said Ho. One pulse of this inflammation-associated metabolite lingers long enough to significantly affect muscle stem cell function in these animals. This could be a natural way to clinically boost muscle regeneration.

The researchers next plan to test the effect of PGE2 on human muscle stem cells in the laboratory, and to study whether and how aging affects the stem cells response. Because PGE2 is also produced by the fetus and placenta during pregnancy, and is approved by the Food and Drug Administration for use in the induction of labor, a path to the clinic could be relatively speedy, they said.

Our goal has always been to find regulators of human muscle stem cells that can be useful in regenerative medicine, said Blau. It might be possible to repurpose this already FDA-approved drug for use in muscle. This could be a novel way to target existing stem cells in their native environment to help people with muscle injury or trauma, or even to combat natural aging.

Other Stanford authors are former technician Matthew Blake; graduate student Nora Yucel; postdoctoral Yu Xin Wang, PhD; former graduate student Klas Magnusson, PhD; research associate Colin Holbrook; research assistant and lab manager Peggy Kraft; and Scott Delp, PhD, professor of bioengineering, of mechanical engineering and of orthopaedic surgery.

The study was supported by the Muscular Dystrophy Association, the Baxter Foundation, the California Institute for Regenerative Medicine and the National Institutes of Health (grants AG044815, AG009521, NS089533, AR063963 and AG020961).

Stanfords Department of Microbiology and Immunology also supported the work.

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LifeCell Community Stem Cell Banking Receives Global Recognition – Medical Dialogues

Chennai: It is believed to be a general practice that technological advancements and new concepts from the western world and other countries percolate into the Indian market. Breaking this taboo and general practice, LifeCell International has made an entry into global platform with their recently launched concept of Community Stem Cell Banking. In 15 years, LifeCell is thesecond stem cell bank to present its innovation at such a prestigious global platform.

Acknowledging the merit of this concept, LifeCell has been invited by AABB (formerly known as American Association of Blood Banks) to portray itsrecently launched concept of Community Stem Cell Banking at the15th International Cord Blood Symposium scheduled to be held at San Diego, USA between 8th 10th June, 2017.

The International Cord Blood Symposium (ICBS) brings all the umbilical cord blood related fields of hematopoietic stem cell transplantation, banking and potential in regenerative medicine together in one interactive three-day conference where world-renowned experts in the field of cord blood will present their new innovations on advancements in the industry.

LifeCell, Indias first and the largest stem cell bank, a pioneer in stem cell industry has been adding new innovations to its services. The innovative concept of Community Stem Cell Banking allows access to donor stem cells within the community, thereby extending the protection of stem cells to all conditions treatable by stem cells. In addition to the child, its siblings, parents and grandparents too can access the community pool of preserved stem cells for treatments when required thereby extending the protection of stem cells to the entire family. Also, there is no limit on number of withdrawals of stem cell units from the community providing a comprehensive protection.

Mr Mayur Abhaya, CEO & Managing Director, LifeCell International said, We are delighted with this acknowledgment for our innovations in stem cell industry. It is a prestigious moment for us being given an opportunity to present Community Stem Cell Banking in a global platform of industry leaders.

Community Stem Cell Banking will be the future of umbilical cord stem cell banking especially in a country like India where the inventory of donor stem cells or bone marrow registries of Indian ethnicity is very low at less than 1% of global inventory and hence the availability of matching donor stem cells is very low. LifeCell, with this new concept, aims to create a huge inventory of donor stem cells within the next few years, which could even exceed the global standards and this will pave way for the highest probability of finding a matching stem cell unit. It is notable to mention that this initiative of LifeCell was featured in Parents Guide to Cord Blood Foundation when this concept was launched in India.

Mr Vinesh Mandot, Technical Lead at LifeCell, would be presenting this innovative model in a session chaired by Dr. Frances Verter, Director of Parents Guide to Cord Blood Foundation at the international symposium.

Source: Press Release

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The US Food and Drug Administrations (FDA) Oncologic Drugs Advisory Committee will review the Biologics

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Chicago medical school launches stem cell biology center – Bradenton Herald

Chicago medical school launches stem cell biology center Bradenton Herald A medical school in Chicago is launching a new center to study tissue regeneration and stem cell biology. The College of Medicine at the University of Illinois at Chicago says there will be a symposium Monday to commemorate the opening of the center, ... and more »

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Removal of aging cells could extend human life – Medical Xpress – Medical Xpress

June 9, 2017 Clearance of SnCs by GCV reduces the development of post-traumatic OA. Credit: UNIST

A recent study, led by an international team of researchers confirms that targeted removal of senescent cells (SnCs), accumulated in many vertebrate tissues as we age, contribute significantly in delaying the onset of age-related pathologies.

This breakthrough research has been led by Dr. Chaekyu Kim of the Johns Hopkins University School of Medicine, who is now at UNIST, and Dr. Ok Hee Jeon of the Johns Hopkins University School of Medicine in collaborations with the Mayo Clinic College of Medicine, the Buck Institute for Research on Aging, the University Medical Center Groningen, Unity Biotechnology, Inc., and the University of California, Berkeley.

In the study, the research team presented a novel pharmacologic candidate that alleviates age-related degenerative joint conditions, such as osteoarthritis (OA) by selectively destroying SnCs. Their findings, published April 24th in Nature Medicine (Impact Factor: 30.357), suggest that the selective removal of old cells from joints could reduce the development of post-traumatic OA and allow new cartilage to grow and repair joints.

Senescent cells (SnCs) accumulate with age in many vertebrate tissues and are present at sites of age-related pathlogy. Although these cells play an essential role in wound healing and injury repair, they may also promote cancer incidence in tissues. For instance, in articular joints, such as the knee and cartilage tissue, SnCs often are not cleared from the area after injury, thereby contributing to OA development.

To test the idea that SnCs might play a causative role in OA, the research team took both younger and older mice and cut their anterior cruciate ligaments (ACL) to minic injury. They, then, administered injections of an experimental drug, named UBX0101 to selectively remove SnCs after anterior cruciate ligament transection (ACLT) surgery.

Preclinical studies in mice and human cells suggested that the removal of SnCs significantly reduced the development of post-traumatic OA and related pain and created a prochondrogenic environment for new cartilage to grow and repair joints. Indeed, the research team reported that aged mice did not exhibit signs of cartilage regeneration after treatment with UBX0101 injections,

According to the research team, the relevance of their findings to human disease was validated using chondrocytes isolated from arthritic patients. The research team notes that their findings provide new insights into therapies targeting SnCs for the treatment of trauma and age-related degenerative joint disease.

Prior to this study, Johns Hopkins Technology Ventures (JHTV) granted UNITY Biotechnology Inc. the right to use the intellectual property around the senescent cell technology. UNITY is a company aiming to develop therapeutics that address age-related diseases. Last October, the company announced $116 million in Series B funding from some of the big names in venture capital, including Amazon CEO Jeff Bezo's venture fund Bezos Expeditions, Mayo Clinic Ventures, Venrock, and ARCH Venture Partners. UNITY has completed a rigorous screening and preclinical testing process of candidate drugs, discovered in this study, and is launching a new clinical trial to assess its first drug, for patients with osteoarthritis of the knee this year.

Explore further: Clearing out old cells could extend joint health, stop osteoarthritis

More information: Ok Hee Jeon et al, Local clearance of senescent cells attenuates the development of post-traumatic osteoarthritis and creates a pro-regenerative environment, Nature Medicine (2017). DOI: 10.1038/nm.4324

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