WALTHAM, Mass.--(BUSINESS WIRE)--ElevateBio, LLC (ElevateBio), a technology-driven company focused on powering transformative cell and gene therapies, today announced that it has partnered with the California Institute for Regenerative Medicine (CIRM) to advance the discovery and development of regenerative medicine as part of CIRMs Industry Alliance Program. Through the partnership, ElevateBio will provide access to high quality, well-characterized iPSC lines to academic institutions and biopharmaceutical companies that are awarded CIRM Discovery and Translational Grants. ElevateBio will also offer access to its viral vector technology, process development, analytical development, and Good Manufacturing Practice (GMP) manufacturing capabilities that are part of its integrated ecosystem built to power the cell and gene therapy industry.

This exciting partnership with CIRM reflects the novelty of our iPSC platform and recognition of our next-generation cell lines that address industry challenges and could potentially save time and costs for partners developing iPSC-derived therapeutics, said David Hallal, Chairman and Chief Executive Officer of ElevateBio. We are setting a new standard with iPSCs that can streamline the transition from research to clinical development and commercialization and leveraging our unique ecosystem of enabling technologies and expertise to help strategic partners harness the power of regenerative medicines.

With $5.5 billion in funding from the state of California, CIRM has funded 81 clinical trials and currently supports over 161 active regenerative medicine research projects spanning candidate discovery through phase III clinical trials. As part of CIRMs expansion of its Industry Alliance Program to incorporate Industry Resource Partners, this partnership will provide CIRM Awardees the option to license ElevateBios iPSC lines produced in xeno-free, feeder-free conditions using non-integrating technologies and have the ability to gain access to other enabling technologies, including gene editing, cell and vector engineering, and end-to-end services within ElevateBios integrated ecosystem, which are essential for driving the development of regenerative medicines.

About ElevateBio:

ElevateBio is a technology-driven company built to power the development of transformative cell and gene therapies today and for many decades to come. The company has assembled industry-leading talent, built state-of-the-art facilities, and integrated diverse technology platforms, including gene editing, induced pluripotent stem cells (iPSCs), and protein, vector, and cellular engineering, necessary to drive innovation and commercialization of cellular and genetic medicines. In addition, BaseCamp is a purpose-built facility offering process innovation, process sciences, and current Good Manufacturing Practice (cGMP) manufacturing capabilities. Through BaseCamp and its enabling technologies, ElevateBio is focused on growing its collaborations with industry partners while also developing its own portfolio of cellular and genetic medicines. ElevateBio's team of scientists, drug developers, and company builders are redefining what it means to be a technology company in the world of drug development, blurring the line between technology and healthcare.

ElevateBio is located in Waltham, Mass. For more information, visit us at http://www.elevate.bio, or follow Elevate on LinkedIn, Twitter, or Instagram.

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ElevateBio Partners with the California Institute for Regenerative Medicine to Accelerate the Development of Regenerative Medicines - Business Wire

Global regenerative medicine market was valued at USD 27.29 Billion in 2020. It is expected to increase at a compound annual rate (CAGR of 11.27%) between 2021 and 2027. Tissue Engineering is the segment expected to see the greatest growth in the Global Regenerative Medicine Market. Biomaterials currently hold the largest market share in global regenerative medicine.

Regenerative medicine has the potential to treat chronic, incurable diseases such as Alzheimers disease, Parkinsons disease, diabetes, and other conditions. The Alliance for Regenerative Medicine estimates that around 1,028 clinical trials in regenerative medicine are currently underway. In 2018, regenerative medicine was funded with a total of USD 13.3 billion in global financing. The forecast period will see a significant increase in investment by market leaders in research and development of regenerative medicines.

Driving Factors

Growing prevalence of chronic diseases, genetic disorders, and cancer

Over the past few decades, the prevalence and incidence of chronic diseases like CVD, cancer and diabetes has increased dramatically around the world. Diabetes and obesity can lead to an increase in the number and complexity of wounds like infections, ulcerations (leg and foot ulcers), as well as surgical wounds. These will need treatment and may result in exorbitant medical costs.

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Restraining Factors

High cost of cell and gene therapies

The cell and gene therapies represent significant medical and scientific advancements for patients with serious and terminal illnesses. These therapies are changing the way diseases are treated and could even be cured. Injectable therapies will enable doctors and other medical professionals to infuse cells/genes through injectable methods, thereby avoiding multiple surgeries and the need for a number of drugs. Although these therapies can be life-saving and more effective than traditional treatments, demand is lower than anticipated. This is due to the high cost of these therapies as well as difficulties in obtaining coverage and reimbursements for them.

Market Key Trends

Recent development

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Regenerative Medicine Market to Garner Bursting Revenues [+USD 27.29 Billion] with Top Growing Companies During 2022-2029 - eTurboNews | eTN

Global cell therapy market value wasUSD 10.23 billionin 2021.This will continue to grow at a CAGR of13.3%over the 2023-2032 forecast period.

Cell therapy is a technology that replaces damaged or dysfunctional cells with healthy functioning cells. Because stem cells can differentiate into the cells needed to repair damaged cells or tissue, they are the cells most often used in advanced therapies. Regenerative medicine is another area where cell therapy can be used. It involves the creation of multidisciplinary medicines that aim to maintain, improve or restore cell, tissue, or organ function. In cell therapy, many cells, including blood, bone marrow cells, mature and immature cells, adult stem, and embryonic cells, are used. Furthermore, transplanted cells, including induced pluripotent stem cells(iPSCs), embryonic and neural stem cells(NSCs), as well as mesenchymal and mesenchymal cells (MSCs), can be divided into two main groups: autologous and non-autologous.

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Cell therapy Market: Drivers

A rise in cell-based research and funding has resulted from the demand for new, better drugs for conditions like cancer and CVD. The Australian government published the Stem Cell Therapies Missionin November 2019. It is a 10-year strategy that will support stem cell research within Australia.The Medical Research Future Fund would fund the project with USD 102million (AU$150million) to support stem cell research and develop new medicines.Innovate UK (UKs innovation agency) was awarded USD 269670 (GBP 267,000) in September 2019 to fund the development of gel stabilization technologies. This was in response to Atelerixs first goal of increasing the shelf life of Rexgenero cell-based therapies that can be stored and transported at room temperature.

Cell therapy Market: Restraints

Despite technological developments and product advancements over the past decade, the industry has been hindered by a shortage of skilled personnel to operate complicated devices like multi-mode readers and flow cytometers. Technology-intensive devices such as spectrophotometers and flow cytometers can produce many data outputs that require skilled analysis and review. According to the National Accrediting Agency for Clinical Laboratory Sciences, there is a worldwide shortage of competent individuals (NAACLS). Over the next decade, Europe and the UK will likely face severe shortages in laboratory capabilities. The UKs medical laboratories will be the most severely affected.

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Cell therapy Market Key Trends:

Market Share is expected to be significant for the Allogeneic Therapies Segment of Cell Therapy

Allogeneic treatments rely on one source of cells to treat many patients. They can cause an immune response in patients and are often combined with immunosuppressive treatments. This is why physicians are increasingly inclined to use allogeneic therapies therapeutically. There is also a growing awareness of the therapeutic potential of cord cells and other tissues in various therapeutic areas. The benefits of allogenic cells are that they produce immune stem cells which kill any remaining cancer cells even after high-dose chemotherapy with cytotoxic drugs. This is called the graft-versuscancer effect. It is used for cancer relapse prevention and treatment. Over the forecast period, the market will be driven by the abovementioned factors.

The segment is expected to grow due to the increasing number of clinical trials needed to obtain regulatory approval for new medications. The segment has many growth opportunities, such as ALLO-501, Allo-501A, and ALLO-715.

Additionally, Allogene Therapeutics Inc. & SpringWorks Therapeutics Inc. have entered into a clinical collaboration agreement to evaluate and treat ALLO-715 in multiple myeloma patients.

This is due to the increasing number of research studies about allogenic therapy for cancer treatment and its associated benefits. The forecast period will see steady growth.

Recent development:

Immunocore was approved by the Food and Drug Administration (KIMMTRAK) in January 2022 to treat metastatic or unresectable uveal melanoma.

Novadip Biosciences was approved by the Food and Drug Administration in March 2021 for regenerative bone product NVD003 to treat rare bone diseases.

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Global Cell Therapy Market to Reach a Capital Expenditure of USD 10.23 billion in 2021 - eTurboNews | eTN

An expert explains how we can reprogram cells, why the gut-brain connection is so exciting and what personalized medicine means for womens health.

Maryam Faizs path to neuroscience wasnt exactly a straight one. She considered architecture. She flirted with urban planning. She took a summer off from her PhD to intern at the BBC and spent another summer in Croatia tracking dolphins across the Adriatic. But a fascination with stem cellsand a meeting in Sweden with one of Canadas leading experts in regenerative medicinefinally drew her to the lab. When you see a neuron, its almost like spaceyou dont know exactly what it is, but its just so beautiful, says Faiz, a professor at the University of Torontos Faculty of Medicine. Theres a feeling of unmitigated possibility.

Her research now focuses on a promising class of star-shaped brain cells called astrocytes. Theyre a kind of glial cell, because glia is Greek for glue, and astrocytes were historically thought of as the sticky stuff that held the neurons of the brain together, Faiz says. Whoops: Turns out scientists were selling astrocytes short. They actually play a huge role in the brains circuitry, regulating blood flow and controlling how information travels across the brain. Not only thatas Faiz and her team are learning, astrocytes may also be harnessed for brain repair, offering the future possibility of custom-made therapeutics for people suffering from neurological injuries and diseases. Astrocytes are quite hot at the moment, in terms of things to study in neuroscience, she says with a laugh.

(Related: The Secret to Learning a New Skill at Any Age)

Lots. Broadly speaking, the brain is not a regenerative organ, like the skin or even the liver. You dont generally regenerate neuronstheyre kind of fixed. So you can have changes in the way the brain develops, and that can lead to neurodevelopmental disorders. You can have an injury, like a stroke, and lose neuronal cells. And then there are neurodegenerative diseases, like Alzheimers and Parkinsons disease, where your neurons become under attack and start to die off.

I can give you a personal example. My younger sister had a traumatic brain injury, and she lost neurons in a region of the brain thats important for verbal communication. It was a small injury, and she was able to recoverbecause even though you lose neurons, the neurons around them can reconnect, which we broadly refer to as neuroplasticity. But my sister still has problems with speaking. The word school is problematic for her, because she cant connect the sounds to the letters, so shell say shul.

The human brain is so interesting because it has this innate ability to rewire, kind of like an electrical circuit. But even small changes in neuronal loss can lead to pretty big impairments in function. And so depending on the region of the brain, you can have different types of impairments, whether that be vision or motor or cognition.

My lab studies astrocytes, which are really important for proper brain function: They fine-tune neuronal information, so they can make that information transmit further, or they can dampen it down. But after injury or disease, some types of astrocytes can become pathological and even start to kill neurons. One example was work out of Harvard on progressive multiple sclerosisand this was preclinical, in mice, not in humans. It showed that if you just removed astrocytes in this end stage, you got improved function.

What we want to do in my lab is create new cells. Basically, you can take any mature cell and hit it with a bunch of genes that are important for its conversion to a new cell type. And so we started by reprogramming astrocytes into neurons. Again, this is preclinicalnothing to do with humansbut in mice after stroke, reprogramming improved mobility and gait to the level of an uninjured animal.

I think the only way that reprogramming will work is if were able to generate really specific therapeutics. And thats where its important to understand the role that different astrocytes play in different types of diseases at different points in that disease. Imagine a scenario where weve identified Astrocyte Type A15, which happens at a certain time post-stroke and is really deleterious. We could go in, target it, change it into another type of cell and leave all the other cells that are important for recovery.

Over the last couple of yearsthis is so excitingtheres been a clear link between the gut and the brain. We know that the bacteria that colonize your gut are really important in brain development, and also really important for neurodegenerative diseases and even injury. So after a stroke, for example, the bacteria in your gut gets altered. And we think this bacteria feeds back onto the brain and can affect the neuroimmune response. We have some really nice dataagain, preclinicalthat shows that just by using probiotics after stroke, it actually improves motor function. Its wild. So one of the cool things weve started looking at is how different types of bacteria in the gut change the astrocyte response in the brain. We think that could be important for developing really novel therapeutics for brain treatment that you could administer in the gut.

Thats what our lab is all about. I think were in an era of personalized medicine. Especially in a system like the brain, which is so precise, you need to think about bespoke therapeutics. Youre not going to want to take out all astrocytes, which are so important, and youre not going to want to put back all types of neurons. This allows us to be really specific.

I mean, were humans, right? Theres so much variation that there can never be a one-size-fits-all response. I think a lot of clinical trials and drugs have failed in that respect. Even if you just think about womens health, 50 percent of our population was almost never tested. And so many of the drugs that have traditionally worked in men dont work in women. Even if we could just conquer that, I think it would be amazing. But with personalized medicine, you start to make discoveries that are going to work no matter where youre from, or what your background is, or your genetics or your sex or your age. Thats where the next 10 to 15 years are going to be really exciting.

Science tends to be quite incremental. But I do think, within 10 to 15 years, we could actually make a big difference with cellular reprogramming. And that helps us keep focused and on track to do the next experiment thats going to take us to the next step thats going to make the biggest difference in peoples lives.

Next: These Activities Help Prevent Dementia, According to a New Study

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How Astrocytes May Be Able to Help With Brain Repair - Best Health Magazine

Aug. 29, 2022 13:00 UTC

Company Continues Accelerated Development of Candidate Pipeline and Patent Portfolio in Respiratory Medicine Space as Phase III Trial Proceeds

ELK CITY, Idaho--(BUSINESS WIRE)-- Therapeutic Solutions International announced today data and filing of a patent covering the use of gene silencing in treatment of Acute Respiratory Distress Syndrome (ARDS), a leading cause of death in emergency rooms.

The Company currently is running a Phase III trial treating COVID-19 induced ARDS but has requested permission from the FDA to expand to ARDS caused by other precipitating factors.

The new data demonstrates feasibility of selectively silencing genes in the lung associated with mortality caused by ARDS, as well as a potent survival advantage in treated versus untreated mice. An approximately 70% reduction in mortality was observed in mice receiving siRNA specifically towards the target genes as compared to mice receiving scrambled siRNA in a TLR4 agonist induced model of ARDS.

The Company plans to continue development of this approach, which is attempted to synergize with the current regenerative medicine programs currently underway.

We are committed to making a significant impact in the lives of patients with ARDS. As part of that commitment, we need to constantly push the limits of medicine and science, said Dr. James Veltmeyer, Chief Medical Officer of the Company. Having previously demonstrated our ability to initiate and run clinical trials, as well as obtain Emergency IND approval, we are confident that we are in the position to accelerate this and other therapeutics in the area of respiratory medicine for which no curative therapeutic approaches exist.

The value of a biotechnology company is in its programs and intellectual property. As our ongoing Phase III continues, our team is brilliantly leveraging this waiting period to continually advance our science. This is what patients and investors count on use to do, said Timothy Dixon, President and CEO of the Company.

About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is http://www.therapeuticsolutionsint.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220829005264/en/

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Therapeutic Solutions International Develops Gene Silencing Therapy for Acute Respiratory Distress Syndrome - BioSpace

MILPITAS, Calif.--(BUSINESS WIRE)--Applied StemCell, Inc. (ASC), a leading cell and gene therapy CRO/CDMO focused on supporting the research community and biotechnology industry for their needs in developing and manufacturing cell and gene products, today announced the expansion of its Current Good Manufacturing (cGMP) facility. ASC has successfully carried out cell banking and product manufacturing projects in its current cGMP suite and is now set on building 4 additional cGMP cleanrooms, cryo-storage space, and a process development and QC/QA space. The expansion of the facility will increase its cell banking and cell product manufacturing capacity and allow ASCs team of experts to work simultaneously on multiple manufacturing projects such as iPSC generation, gene editing, differentiation, and cell bank manufacturing for safe and efficacious therapeutic products.

We are very excited to move forward with the expansion of our cGMP facility, said Dr. David Lee, Ph.D., Head of GMP and Quality. Our team has been working closely with our clients to ensure delivery of high-quality clinical grade products. We thank our customers for their support and trust. With the addition of 4 cGMP cleanrooms, we will be able to assist a greater number of researchers focused on cell and gene therapy.

President and CEO, Dr. Ruby Yanru Chen-Tsai, Ph.D. stated, We are committed to becoming a CDMO leader to support regenerative medicine and cell/gene therapy development and manufacturing. We aim to expand our bio-manufacturing capacity to meet the fast-growing demand in the cell and gene therapy industry. Our unique platform of GMP-grade allogeneic iPSC and TARGATTTM gene editing technology provides our partners great advantages, including shorter manufacturing timelines, non-viral gene editing, and genomic stability and safety.

Construction will begin within the next month, and the company has already begun the staff hiring process. ASC hopes to have the expansion completed and a team built that will be ready to take on as much as 4 times more new projects early next year.

About Applied StemCell, Inc.

ASC has a Drug Manufacturing License from the California Department of Public Health, Food and Drug Branch (FDB). It has a Quality Management System (ISO 13485 certified) and established cGMP-compliant protocols for cell banking and manufacturing, iPSC generation, genome editing, iPSC differentiation, and cell product manufacturing. With over 13 years of gene-editing and stem cell expertise, ASC offers comprehensive and customized cell and gene CRO/CDMO solutions. Its core iPSC and genome editing (CRISPR and TARGATTTM) technologies, facilitate site-specific, large cargo (up to 20kb) transgene integration and the development of allogenic cell products.

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Applied StemCell Announces the Expansion of its cGMP Manufacturing Facility to Support Cell and Gene Therapy - Business Wire

Requesting Input: NIAMS Strategic Plan 20252029

NIAMS is updating its Strategic Plan to help guide the research it supports. The new plan will cover fiscal years 20252029 and will focus on cross-cutting thematic research opportunities where the Institute can be best positioned to make a difference in the lives of all Americans. NIAMS invites feedback from researchers in academia and industry, health care professionals, patient advocates and health advocacy organizations, scientific or professional organizations, federal agencies, and interested members of the public. Professional societies and patient organizations are strongly encouraged to submit a single response that reflects the views of their membership as a whole. Responses can be submitted on this websiteand are due November 30, 2022.

NIAMS is operating under the FY 2022 Consolidated Appropriations Act. The interim funding plan for research and training grants represents the most current information as of the date cited on the web page.

Get the latest public health information from the Centers for Disease Control and Prevention, and the latest funding opportunities and research news from the National Institutes of Health (NIH). Additional news and resources include:

On September 22, 2022, watch NIH videocast, Cartilage Preservation and Restoration for Knee Osteoarthritis. NIAMS is planning this roundtable to engage stakeholders in discussing challenges, gaps, and opportunities regarding regenerative medicine approaches for cartilage preservation and restoration in knee osteoarthritis and where and how NIAMS could play a role and move the field forward.

Mariana Kaplan, M.D., Chief of the Systemic Autoimmunity Branch in the NIAMS Intramural Research Program, aims to stop the immune system from harming the cells it is supposed to defend. Her unique expertise is being applied to various disease areas, including autoimmune diseases, especially systemic lupus erythematosus, or lupus, Sjogrens syndrome, inflammatory illnesses, and COVID-19.

Researchers supported in part by NIAMS found that a molecule, called Lac-Phe, produced during exercise by various mammalsincluding peoplereduces food consumption and obesity in mice.

The NIAMS STAR program provided two funding supplements to early-career stage investigators who have renewed their first NIAMS-funded R01 grant:

Erika Geisbrecht, Ph.D., is a Professor of biochemistry and molecular biophysics at Kansas State University in Manhattan. She leads a NIAMS-supported research project using the Drosophila model to determine mechanisms that prevent protein aggregation, and ultimately cellular degeneration, in muscle.

Corey Neu, Ph.D., is the Donnelly Family Endowed Professor of mechanical engineering at the University of Colorado at Boulder. He leads a NIAMS-funded research project to establish a noninvasive imaging method of measuring cartilage strain to predict osteoarthritis development.

The AMP BGTC announced that it has selected 14 rare disease candidates, including two rare orthopaedic conditionsfibrodysplasia ossificans progressiva and mucopolysaccharidosis IVA (MPS, IVA, Morquio A Syndrome). In addition, a new request for proposals has been issued for clinical trial proposals directed to one of the 14 bespoke indications.

The U.S. Food and Drug Administration (FDA) approved Opzelura (ruxolitinib) cream for the treatment of nonsegmental vitiligo in adult and pediatric patients age 12 and older. Opzelura is a topical Janus kinase (JAK) inhibitor.

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NIAMS Update, Issue 4, 2022 | NIAMS - National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

The buzzy field of synthetic biology aims to create complex life from customized DNA, a goal that has been decades in the making.

Now, researchers have taken a major step toward that sci-fi ambition: For the first time ever, a team has successfully mixed and matched mammal chromosomes, large-scale changes that would ordinarily take millions of years to achieve naturally via evolution. Such research might shed light on diseases stemming from chromosomal abnormalities in people, according to a new study published in Science.

HERE'S THE BACKGROUND Genetic mutations normally help rearrange chromosomes over millions of years. For example, the human genome is normally divided into 23 pairs of chromosomes, with each parent supplying a set of 23 chromosomes. But the gorilla genome consists of 24 pairs. Thats because two sets of chromosomes fused in human ancestors, while they remained separate in gorilla ancestors.

Rearrangements of chromosomes usually happen roughly every 1.6 per million years in primates and every 3.2 to 3.5 per million years in rodents. But synthetic biologists are exploring ways to engineer these changes on a far shorter timeline certainly within a human lifetime.

"An ultimate goal of synthetic biology is to generate complex multicellular life with designed DNA sequences," says study co-author Li-Bin Wang, a cell biologist at the Beijing Institute for Stem Cell and Regenerative Medicine.

To create such organisms, she explains, its necessary to carry out the sort of large-scale manipulation proven possible in this experiment.

Previously, researchers succeeded in engineering chromosomes in yeast, a fungus that makes our beloved sourdough and beer possible. But until now, no one had accomplished it with mammals.

The problem was that molecules are normally bound to DNA that help control which genes are active or inactive, a phenomenon known as genomic imprinting. Past chromosome-modifying experiments in mammal cells often disrupted the patterns of this genomic imprinting in mammal cells, which in turn prevented growing live animals from these cells.

Over the past few decades, scientists have blasted cells with chemicals or radiation to cause massive shifts in chromosomes. But now, synthetic biologists want to make these changes with a more precise, repeatable method.

What they did In the new study, researchers in China worked with mice, which normally have 20 pairs of chromosomes. They performed the experiment on embryonic stem cells from unfertilized mouse embryos, each of which only contained one set of chromosomes.

The scientists found that getting rid of three imprinted regions can kick off genomic imprinting in embryonic stem cells. As a result, they could fuse chromosomes in these cells and allow them to grow into embryos.

In some stem cells, the researchers fused two medium-sized chromosomes the tail of number 4 to the head of number 5, leading to cells dubbed 4+5. In others, they fused the two largest chromosomes, numbered 1 and 2. They did this by either sticking the tail of chromosome 1 to the head of chromosome 2 (for cells dubbed 1+2) or fusing the tail of chromosome 2 with the head of chromosome 1 (cells that were called 2+1).

The scientists then injected these altered embryonic stem cells into mouse egg cells, where they could develop into embryos in surrogate mouse mothers. These each had only 19 pairs of chromosomes, one pair fewer than natural mice. While mouse pregnancy lasts around three weeks, the genetic tweaking only took a few days magnitudes quicker than actual evolution.

The technique used by Wangs team wont be used to create mutants, it seems.MARK GARLICK/SCIENCE PHOTO LIBRARY/Science Photo Library/Getty Images

What they found The scientists observed that the 2+1 cells acted abnormally, so the embryos died only about 12 days into development. Compared to both typical mice and the 4+5 mice, the 1+2 cells developed into pups that grew into larger, more anxious, and slower-moving adults.

Only the 4+5 mice were able to produce offspring with standard mice, but at a much lower rate than typical lab mice. Still, they were able to pass on their fused chromosome to their rodent babies. This win has major ramifications for future research.

"Our chromosome fusion technology adds to the toolbox of synthetic biology," Wang says.

Whats next Moving forward, Wangs team may create mice with chromosome fusions to better understand diseases associated with chromosome abnormalities, such as infertility and childhood leukemia, Wang says.

You may be wondering: Can researchers use this technique to forge new species? Unfortunately for sci-fans, Wang says its intended to study how chromosomes evolve in nature, rather than creating some sort of mutant creature.

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Scientists just bypassed millions of years worth of evolution in mice - Inverse